This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Dose-response Study of Sodium Nitroprusside in Children Requiring Controlled Hypotension in the Operating Room (NCT00135668), a randomized phase 2 study. The primary outcome is Change in Mean Arterial Pressure (MAP) From the Baseline MAP.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00135668 |
| Phase | Phase 2 |
| Condition | Hypotension |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 211 |
| Arms in the primary outcome | n/a |
| Lead sponsor | The Emmes Company, LLC |
| Results posted | Yes |
2. Clinical Question
Population
Children undergoing surgery who require blood pressure lowering are the population described in the study summary. The primary-outcome population is narrower: the record describes an ITT Efficacy Evaluable Population of randomized and treated patients with a pretreatment baseline MAP and a second MAP measurement. The remaining details of that population description are not reported in the registry record.
Intervention
The intervention was sodium nitroprusside delivered by infusion. The four listed dose groups were 0.3 μg/kg/Min, 1 μg/kg/Min, 2 μg/kg/Min, and 3 μg/kg/Min. The record says infusion began after a 5-minute period of stable anesthesia or sedation, then increased stepwise toward the assigned full rate.
Comparator
The comparison was among the four listed sodium nitroprusside dose groups. The registry record does not list a placebo group or a no-infusion group. Accordingly, the central comparison is between dose levels, rather than between sodium nitroprusside and an untreated control.
Primary question
The primary endpoint was change in mean arterial pressure (MAP) from baseline, measured over approximately 30 minutes. The clinical question was whether the observed MAP change differed across the sodium nitroprusside dose groups during the blinded infusion period. Numerical primary-endpoint results and a registry-reported dose-group comparison are not reported in the registry record, so the magnitude and precision of any differences cannot be described.
3. Trial Design
The registry describes a phase 2, multicenter, randomized, double-blind, parallel-group, dose-ranging study of sodium nitroprusside in pediatric subjects. Its official title also calls it effect-controlled and identifies pharmacokinetics and pharmacodynamics as study aims. The record marks masking as quadruple. These labels describe the trial’s recorded design; the details of who was masked and how masking was maintained are not reported in the registry record.
The registry lists four sodium nitroprusside dose groups: 0.3 μg/kg/Min, 1 μg/kg/Min, 2 μg/kg/Min, and 3 μg/kg/Min. It describes infusion initiation after a 5-minute period of stable anesthesia or sedation, followed by stepwise increases toward the full dose rate. The available arm descriptions specify 5 ± 1 minutes at 1/3 of the full rate. Further details of the stepwise schedule are not reported in the registry record.
Enrollment is recorded as 211. The trial began in 2005-08, had primary completion in 2008-03, and is marked completed. Those administrative details do not establish how many participants contributed data to each endpoint or analysis; such group-specific analysis counts are not reported in the registry record.
The stated purpose was to examine sodium nitroprusside efficacy and safety in children undergoing surgery who require blood pressure lowering to reduce surgical blood loss. The primary endpoint was change in MAP from baseline, with a timeframe of approximately 30 minutes. Listed secondary outcomes include MAP change during blinded infusion, infusion rate associated with a predetermined MAP target, and the number of participants reaching that target. Numerical results for these outcomes are not reported in the registry record.
The record does not report the randomization sequence method, allocation concealment procedures, the detailed masking procedures, or a statistical analysis plan. The intended sample-size justification is also not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Of the 206 randomized participants, 3 discontinued pre-operatively and 203 participants completed the study and no patients discontinued the study post operative. Participants counted as completing the study may have stopped the blinded study drug period early but continued on to the open-label study drug period and follow-up period.
Overall Study - Randomized to be Dosed
| Stage | 0.3 μg/kg/Min | 1 μg/kg/Min | 2 μg/kg/Min | 3 μg/kg/Min |
|---|---|---|---|---|
| STARTED | 51 | 49 | 55 | 51 |
| COMPLETED | 50 | 49 | 53 | 51 |
| NOT COMPLETED | 1 | 0 | 2 | 0 |
Reasons for not completing this period:
| Reason | 0.3 μg/kg/Min | 1 μg/kg/Min | 2 μg/kg/Min | 3 μg/kg/Min |
|---|---|---|---|---|
| Discontinued pre-operatively | 1 | 0 | 2 | 0 |
Blinded Treatment Phase-Randomized/Dosed
| Stage | 0.3 μg/kg/Min | 1 μg/kg/Min | 2 μg/kg/Min | 3 μg/kg/Min |
|---|---|---|---|---|
| STARTED | 50 | 49 | 53 | 51 |
| COMPLETED | 38 | 23 | 13 | 18 |
| NOT COMPLETED | 12 | 26 | 40 | 33 |
Analysis population for the primary outcome, as defined in the registry: Change from Baseline in MAP across the Sodium Nitroprusside (SNP) dose groups by mean at Baseline, 30 mins (LOCF), and change from Baseline for the ITT Efficacy Evaluable Population consisted of randomized and treated patients who had a pre-treatment Baseline MAP and a second MAP determined within 30 mins of study drug infusion at the starting dose
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: 211 participants were enrolled in the study; 206 were randomized, 5 discontinued preoperatively. Of the 206, 3 discontinued preoperatively after randomization resulting in 203 participants who completed the study. These 203 participants constituted the baseline population.
| Characteristic | Unit | 0.3 mcg/kg/Min | 1 mcg/kg/Min | 2 mcg/kg/Min | 3 mcg/kg/Min | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 50 | 49 | 53 | 51 | 203 | |
| Age, Customized | Months | 110.30 (SD 75.424) | 114.74 (SD 71.479) | 114.21 (SD 73.864) | 111.30 (SD 76.429) | 112.64 (SD 73.610) |
| Sex: Female, Male: Female | Participants | 14 | 21 | 20 | 19 | 74 |
| Sex: Female, Male: Male | Participants | 36 | 28 | 33 | 32 | 129 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 11 | 11 | 12 | 13 | 47 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 39 | 38 | 41 | 38 | 156 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Mean Arterial Pressure (MAP) From the Baseline MAP, measured over Approximately 30 minutes.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mm Hg |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in mean arterial pressure (MAP) from baseline, expressed in mm Hg. MAP is a continuous measure of arterial pressure, and describing change from baseline focuses attention on how the measure shifted during the study period rather than on a single measurement alone. The registry identifies the primary measure as a mean with standard deviation and gives an approximately 30-minute timeframe. It describes baseline MAP through the end of the blinded phase, with the 30-minute value using last observation carried forward (LOCF).
In general, a continuous endpoint can retain information about the size of changes across participants, rather than reducing outcomes to whether a threshold was or was not crossed. That can make it useful for comparing dose groups when the research question concerns the extent of a physiological change. MAP is also relevant to the stated purpose of controlled hypotension during surgery. This general rationale does not establish that the endpoint captures every aspect of surgical blood loss or safety.
The registry lists the primary population as the ITT Efficacy Evaluable Population and gives some eligibility details: randomized and treated patients with a pretreatment baseline MAP and a second MAP measurement. The rest of that population description is not reported in the registry record. Most importantly for interpreting the endpoint, numerical mean changes, standard deviations, dose-group sample sizes for the analysis, and a statistical comparison are not reported in the registry record. Without those results, the direction, magnitude, and precision of group differences cannot be assessed.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study question and design, but it does not give the numerical results needed to interpret the primary endpoint. There are no reported dose-specific mean changes in MAP, standard deviations, confidence intervals, or primary-comparison estimates in the record. It therefore does not support a description of how much MAP changed in any group, whether changes differed across groups, or how precisely those changes were estimated.
The design is dose-ranging: randomized participants were assigned to one of four listed sodium nitroprusside infusion rates. A dose-ranging study can inform whether patterns across dose levels are consistent with a relationship between assigned dose and an outcome. In general, examining all groups matters; a single comparison selected after looking at the results may not represent the overall pattern. In this case, numerical primary-endpoint results are not reported in the registry record, so neither a pattern nor a dose-response relationship can be characterized.
The record identifies the primary endpoint as change from baseline in MAP over approximately 30 minutes and describes use of LOCF for the 30-minute value. It also names secondary measures related to MAP change, infusion rate at a target, and reaching that target. The numerical results and uncertainty for those secondary outcomes are not reported in the registry record. Thus, their listed presence should not be mistaken for evidence about the size or consistency of an observed effect.
The safety information is more concrete but limited. For serious adverse events, the registry gives affected counts of 24 among 50 at risk in the 0.3 μg/kg/Min group, 22 among 49 at risk in the 1 μg/kg/Min group, 18 among 53 at risk in the 2 μg/kg/Min group, and 20 among 51 at risk in the 3 μg/kg/Min group. These are descriptive counts, not a comparative analysis. The record does not report an adjusted comparison, uncertainty intervals, or an interpretation of differences among groups. Death counts are not reported in the registry record.
The posted serious-event terms include Hypotension at 32.0%, Blood Pressure decreased at 4.1%, Postoperative Infection at 4.0%, Pancreatitis at 3.8%, Anaemia at 2.0%, and Pyrexia at 2.0%. The registry does not provide arm-specific percentages for these terms in the registry record for interpretation. They should therefore be read as listed safety terms, not as a dose-group comparison. No causal conclusion about a particular dose follows from these descriptive entries.
Overall, the record permits a description of the randomized dose-ranging design and selected safety counts, but it does not permit an estimate of primary-endpoint effect or its precision. The absence of numerical outcome results is not evidence that there was no change or no difference; it means the relevant results are not reported in the registry record.
9. Statistical Methods Explained
What does randomization contribute?
The registry identifies the study as randomized and parallel group. In general, randomization assigns participants to study groups using a chance-based process. Its statistical purpose is to reduce systematic differences between groups at assignment, including differences that researchers may not have measured. It does not guarantee identical groups, and it cannot by itself remove bias from missing outcomes, deviations after assignment, or selective reporting. The specific sequence-generation and allocation-concealment methods are not reported in the registry record.
A parallel-group design means each participant is assigned to a group rather than being described as receiving every dose in sequence. Here, the listed groups correspond to four sodium nitroprusside dose levels. The registry identifies quadruple masking, but the identities of the masked parties and practical masking procedures are not reported in the registry record. These details matter because expectations about treatment assignment can affect care, outcome measurement, or reporting, depending on the setting.
How should a continuous endpoint be understood?
MAP change is a continuous outcome: its values can span a range rather than belonging only to a yes-or-no category. The registry says the primary measure is summarized by a mean and standard deviation. In general, the mean describes the average value in a group, while the standard deviation describes the spread of individual observations around that average. A mean change alone would not show how variable participant responses were. The record does not report the group means or standard deviations for the primary endpoint.
When continuous outcomes are compared between randomized groups, an estimate of the difference and an uncertainty interval can help describe both the size and precision of the comparison. A confidence interval is a general statistical tool for expressing uncertainty around an estimate under the assumptions of the analysis. It is not a guarantee that the true value lies within a particular interval. No primary-endpoint confidence intervals or comparison estimates are reported in the registry record, so precision cannot be evaluated from the posted record.
What does the dose-ranging structure allow researchers to ask?
In general, multiple assigned dose levels allow researchers to examine whether outcome patterns vary with dose. Such an assessment might involve comparing group summaries or using a model that represents dose as ordered or quantitative. The choice depends on the prespecified question, outcome distribution, and analysis plan. The registry record does not report the analysis model, planned contrasts, or a formal dose-response method. It also does not report numerical primary results, so a dose pattern cannot be reconstructed from the record.
The official title describes the study as effect-controlled and as examining pharmacokinetics and pharmacodynamics. Those terms identify stated study aims, but the detailed operational definition of effect control and the statistical methods used for those aims are not reported in the registry record. The listed primary endpoint remains change in MAP from baseline.
What does LOCF mean for the endpoint?
The primary endpoint description says the 30-minute MAP value used last observation carried forward (LOCF). In general, LOCF fills a missing later measurement with the participant’s last observed value. It can make an analysis dataset easier to construct, but it relies on an assumption that carrying the last value forward is a reasonable representation of the later value. That assumption may be unsuitable when the outcome is changing over time or when missingness is related to a participant’s condition. LOCF does not eliminate uncertainty created by missing data.
The registry does not report how many measurements were missing, why they were missing, or whether sensitivity analyses using alternative missing-data assumptions were conducted. It also does not report enough detail to determine whether LOCF was used for every analysis or only for the stated 30-minute primary measure. The results cannot be recalculated from the registry information.
What is over-dispersion, and is it relevant?
In general, over-dispersion occurs when observed variability exceeds what a statistical model assumes. It is especially relevant to certain count outcomes, where ignoring extra variability can make uncertainty estimates too narrow. The primary endpoint in this trial is a continuous MAP change, not a count. The registry does not report the model or data diagnostics used for the primary analysis, so there is no basis to say whether over-dispersion was assessed or relevant to a particular analysis. No special model adjustment should be assumed.
How should planning illustrations be read?
In general, a sample-size planning illustration asks how many participants per arm might be needed under stated assumptions to detect an effect at a chosen significance level and power. Such a calculation is prospective planning, not a description of what the completed study demonstrated. The registry’s planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect set as a stated fraction of the observed effect. For time-to-event calculations, the stated convention is a total number of events; for other calculations, it is participants per arm.
These assumptions do not establish the trial’s original design rationale. The trial’s own sample-size justification is not reported in the registry record. Any planning illustration based on an observed effect is hypothetical and should not be read as observed power, a test of whether the study succeeded, or evidence that the effect is reproducible. Numerical planning estimates are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary MAP-change endpoint and several secondary outcomes, including MAP change during blinded infusion, infusion rate associated with a predetermined target, and the number of participants reaching that target. When a study examines multiple outcomes or multiple comparisons, the chance of at least one apparently notable result can increase. In general, a prespecified multiplicity strategy may address that issue through adjusted testing or by defining a hierarchy of outcomes. The statistical plan and any multiplicity adjustment are not reported in the registry record. No conclusion about adjustment should be inferred from the endpoint list alone.
The primary endpoint description specifies a 30-minute value using last observation carried forward (LOCF). In general, this method carries a participant’s last observed value forward when a later value is missing. The registry does not report the amount or reasons for missing data, the number of participants included in each endpoint analysis, or sensitivity analyses using alternative assumptions. The effect of missing data on the estimates therefore cannot be assessed from the record.
The named primary population is the ITT Efficacy Evaluable Population, described as randomized and treated patients with a pretreatment baseline MAP and a second MAP measurement. The population description ends after stating that the second MAP was determined within 3; further detail is not reported in the registry record. The record does not explain how participants lacking the required measurements were handled or how this population relates to all randomized participants.
Randomization is recorded, but the analysis populations, exclusions, and handling of protocol deviations are not fully described. Numerical primary results are also not reported in the registry record. Together, these omissions limit assessment of the analysis set, missing-data sensitivity, and the interpretation of multiple outcome tests.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| 0.3 μg/kg/Min | 24 | 50 | 48.0% |
| 1 μg/kg/Min | 22 | 49 | 44.9% |
| 2 μg/kg/Min | 18 | 53 | 34.0% |
| 3 μg/kg/Min | 20 | 51 | 39.2% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| 0.3 μg/kg/Min | 50 of 50 |
| 1 μg/kg/Min | 49 of 49 |
| 2 μg/kg/Min | 53 of 53 |
| 3 μg/kg/Min | 51 of 51 |
Most frequent serious adverse event terms
| Event term | Organ system | 0.3 μg/kg/Min | 1 μg/kg/Min | 2 μg/kg/Min | 3 μg/kg/Min |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | 16 of 50 | 15 of 49 | 11 of 53 | 15 of 51 |
| Blood Pressure decreased | Investigations | 1 of 50 | 2 of 49 | 1 of 53 | 1 of 51 |
| Pancreatitis | Gastrointestinal disorders | 0 of 50 | 0 of 49 | 2 of 53 | 0 of 51 |
| Pyrexia | General disorders | 0 of 50 | 1 of 49 | 0 of 53 | 1 of 51 |
| Postoperative Infection | Infections and infestations | 2 of 50 | 0 of 49 | 0 of 53 | 0 of 51 |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | 0 of 50 | 0 of 49 | 1 of 53 | 1 of 51 |
| Anaemia | Blood and lymphatic system disorders | 0 of 50 | 1 of 49 | 0 of 53 | 0 of 51 |
| Pseudocyst | General disorders | 0 of 50 | 0 of 49 | 0 of 53 | 1 of 51 |
| Sepsis | Infections and infestations | 0 of 50 | 1 of 49 | 0 of 53 | 0 of 51 |
| Serratia Infection | Infections and infestations | 1 of 50 | 0 of 49 | 0 of 53 | 0 of 51 |
Most frequent non-serious adverse event terms
| Event term | Organ system | 0.3 μg/kg/Min | 1 μg/kg/Min | 2 μg/kg/Min | 3 μg/kg/Min |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | 35 of 50 | 37 of 49 | 40 of 53 | 41 of 51 |
| Pyrexia | General disorders | 16 of 50 | 16 of 49 | 15 of 53 | 24 of 51 |
| Vomiting | Gastrointestinal disorders | 14 of 50 | 13 of 49 | 21 of 53 | 16 of 51 |
| Hypertension | Vascular disorders | 10 of 50 | 11 of 49 | 12 of 53 | 19 of 51 |
| Anaemia | Blood and lymphatic system disorders | 17 of 50 | 13 of 49 | 8 of 53 | 11 of 51 |
| Rebound Hypertension | Vascular disorders | 7 of 50 | 10 of 49 | 15 of 53 | 16 of 51 |
| Urine Output decreased | Investigations | 8 of 50 | 10 of 49 | 9 of 53 | 12 of 51 |
| Tachycardia | Cardiac disorders | 6 of 50 | 11 of 49 | 8 of 53 | 6 of 51 |
| Constipation | Gastrointestinal disorders | 6 of 50 | 7 of 49 | 7 of 53 | 6 of 51 |
| Face Oedema | General disorders | 6 of 50 | 4 of 49 | 8 of 53 | 5 of 51 |
Serious events with the highest arm-level rate: hypotension (32.0%), blood pressure decreased (4.1%), postoperative infection (4.0%), pancreatitis (3.8%), anaemia (2.0%).
The registry reports serious adverse event counts by dose group. In the 0.3 μg/kg/Min group, 24 of 50 participants at risk were affected; in the 1 μg/kg/Min group, 22 of 49 were affected; in the 2 μg/kg/Min group, 18 of 53 were affected; and in the 3 μg/kg/Min group, 20 of 51 were affected. These are counts within each listed group, not estimates of comparative risk. The record does not provide a statistical comparison or uncertainty intervals for these figures.
Listed serious-event terms and percentages are Hypotension, 32.0%; Blood Pressure decreased, 4.1%; Postoperative Infection, 4.0%; Pancreatitis, 3.8%; Anaemia, 2.0%; and Pyrexia, 2.0%. The record does not specify an arm-specific breakdown for these percentages in the registry record for interpretation. They should not be assigned to individual dose groups or treated as direct comparisons between doses.
The registry also reports other adverse events as affecting all participants at risk in each group: 50 of 50, 49 of 49, 53 of 53, and 51 of 51, respectively. These are reported counts; they do not identify the types or severity of those other events. Death counts are not reported in the registry record. In general, adverse-event counts describe events recorded during a study and do not by themselves establish that the study drug caused them.
12. What the Result Does, and Does Not, Mean
This trial’s record describes a randomized, quadruple-masked, parallel-group, phase 2 dose-ranging study of sodium nitroprusside in children requiring controlled hypotension during surgery. It identifies four infusion-rate groups and a primary endpoint focused on MAP change from baseline over approximately 30 minutes. These details establish what the study set out to examine, not what the outcome comparison found.
The registry does not report numerical primary-endpoint results. As a result, the posted record does not show the magnitude or direction of MAP change in each group, the difference between groups, or the precision of any estimated contrast. It cannot establish whether a higher dose was associated with a larger change, whether group results were similar, or whether any observed pattern was statistically distinguishable from chance.
The safety entries provide descriptive serious adverse event counts and a list of serious-event terms with percentages. They do not provide a complete comparative safety analysis, arm-specific term rates, or uncertainty intervals. Counts should not be interpreted as proof that a dose caused an event, and the absence of a reported death count cannot be interpreted as a count of zero.
In general, a trial result is most informative when the estimated effect is considered alongside its uncertainty, the analysis population, missing-data handling, and the planned comparisons. Those elements are not fully available in the registry record. The study’s stated aims and completed status do not substitute for numerical outcomes.
Accordingly, the record supports a description of the design, endpoint, and selected safety reporting. It does not support a conclusion about efficacy, a ranking of doses, or a claim that a particular dose is preferable. Those conclusions would require outcome and analysis information that is not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically notable as a dose-ranging study rather than a simple comparison of an active treatment with no treatment. Four sodium nitroprusside dose groups create the opportunity to examine how a continuous physiological outcome, MAP change, varies across assigned dose levels. In general, this can help characterize a dose-response pattern, but only if the outcome estimates and their uncertainty are reported and interpreted according to a clear analysis plan.
The primary endpoint is a continuous measure, summarized in the registry as a mean with standard deviation. That choice retains information about the scale and spread of MAP changes. The record also lists target-based outcomes, which frame response in terms of reaching a predetermined MAP range. Continuous and threshold-based outcomes answer related but distinct questions: one concerns the size of change, while another concerns whether a defined target was reached. Numerical results for these outcomes are not reported in the registry record.
The trial also illustrates why design labels alone are insufficient for statistical interpretation. Randomization and quadruple masking are recorded, but the randomization procedures, masking details, analysis model, missing-data sensitivity analyses, and multiplicity plan are not reported. Those details would help readers understand how estimates were produced and how robust they may be to analysis choices.
Finally, the record separates a meaningful design description from the evidence needed to quantify a result. Enrollment and completion status establish trial administration, while the reported safety counts offer limited descriptive information. Neither supplies the missing primary estimates. The statistical importance of the study therefore lies in its structured comparison of multiple dose levels and in the need for transparent numerical reporting to assess the resulting evidence.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most consequential limitation for interpretation is that numerical primary-endpoint results are not reported in the registry record. Group means, standard deviations, analysis sample sizes, estimated comparisons, and confidence intervals are unavailable. Without these, the primary outcome’s magnitude, direction, and precision cannot be described.
The record identifies an ITT Efficacy Evaluable Population but gives only a partial description. It does not report the number of participants included in that population or explain exclusions and analysis-set construction in detail. The description of a second MAP measurement ends after the words within 3, without the remaining qualification. The consequences of that incomplete information cannot be resolved from the registry record.
Although the primary endpoint description specifies LOCF for the 30-minute value, the record does not report how much data were missing, why values were missing, or whether alternative missing-data analyses were performed. The analysis model, planned dose comparisons, and any multiplicity procedures are also not reported. These gaps limit assessment of model assumptions and the stability of any potential findings.
Safety reporting is also limited for comparative interpretation. The registry gives serious-event counts by dose group and a list of serious-event terms with percentages, but does not provide arm-specific percentages for those terms or statistical comparisons. Death counts are not reported in the registry record. The detailed randomization and masking procedures, protocol adherence information, and trial-specific sample-size justification are not reported either.
These limitations concern what can be established from the registry record. They do not show that the study lacked analyses or that its results were null; the relevant details and numerical outcomes are simply not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Dose-response Study of Sodium Nitroprusside in Children Requiring Controlled Hypotension in the Operating Room — NCT00135668.
- Registry record last updated 2024-01-02; status last verified 2023-12.
- Results first posted 2024-01-02.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes a completed phase 2, multicenter, randomized, quadruple-masked, parallel-group dose-ranging study of sodium nitroprusside in children requiring controlled hypotension during surgery. Enrollment is recorded as 211. The listed dose groups are 0.3 μg/kg/Min, 1 μg/kg/Min, 2 μg/kg/Min, and 3 μg/kg/Min.
The primary endpoint was change in MAP from baseline over approximately 30 minutes, with a 30-minute value using LOCF. The record lists secondary outcomes involving MAP change, infusion rate at a target, and target attainment. Numerical results for the primary endpoint and these secondary outcomes are not reported in the registry record.
Serious adverse event counts are reported for each dose group, alongside selected serious-event terms and percentages. The record does not provide a full comparative safety analysis, and death counts are not reported in the registry record. Details of the statistical plan, multiplicity handling, and the trial’s sample-size justification are also not reported.