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 The Association Between Peri-Operative Hyperglycemia and Major Morbidity and Mortality (NCT00487162), a randomized na study. The primary outcome is Wound Infection.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00487162 |
| Phase | NA |
| Condition | Hyperglycemia |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 56 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Medicine and Dentistry of New Jersey |
| Results posted | Yes |
2. Clinical Question
Population
Patients undergoing non-cardiac major surgery were the population of interest. The registry record lists hyperglycemia as the condition and reports enrollment of 56. It does not provide further eligibility criteria or a fuller description of the participants included in the study.
Intervention
The intensive glycemic control arm used continuous insulin infusion. The description says infusion would begin when glucose exceeded 110 mg / dL on two consecutive samples, with treatment adjusted to maintain glucose between 80; the recorded description ends at that point, so the upper end of the target range is not reported in the registry record.
Comparator
The conventional glycemic control arm used continuous insulin infusion if glucose exceeded 200 mg/dL, with the stated goal of maintaining glucose between 180-200mg/dL. The registry identifies the study as randomized, open-label, and parallel-group; it does not describe masking.
Primary question
The primary outcome was wound infection at 7-10 days post op. The broader study question was whether intensive peri-operative glucose control was associated with altered morbidity and mortality in non-cardiac major surgery patients. The registry states that no analysis was done because the study was terminated due to patient safety concerns.
The clinical rationale recorded for the study is that surgery may raise glucose and that peri-operative glucose control could be related to complications. The planned comparison therefore concerned two treatment strategies, not simply whether glucose was high or low at one measurement. The record also lists hemodynamic instability as a secondary outcome, but it does not report an analysis of that outcome.
Because the study ended without analysis of its primary outcome, the registry does not establish whether the treatment strategies differed in wound infection or other morbidity or mortality outcomes. The clinical question can be identified from the planned arms and endpoint, but it cannot be answered from a reported comparative outcome estimate in this record.
3. Trial Design
The registry describes a randomized, parallel-group trial with no masking. The listed arms were intensive glycemic control and conventional glycemic control. Random assignment is intended, in general, to make treatment groups comparable at the start of a trial with respect to both measured and unmeasured characteristics. That design feature does not by itself provide evidence of an outcome difference: an outcome analysis is needed to estimate the comparison, and the registry says no primary outcome analysis was done.
Enrollment is listed as 56. The safety results separately list 28 at risk in the conventional arm and 21 at risk in the intensive arm. Those are the posted arm-specific denominators for the adverse-event data; they are not a reported analysis population for the primary endpoint. The registry does not explain how these figures relate to enrollment or whether all enrolled participants were included in the safety counts. It would not be appropriate to infer the number analyzed for wound infection from these values.
The record identifies the study as terminated and gives patient safety concerns as the reason for termination in the primary outcome description. The start is listed as 2007-06 and primary completion as 2009-01. The phase is listed as NA. The record does not give further detail on when or how the safety concerns arose, what event prompted termination, or whether an independent monitoring group reviewed the accumulating data.
The intervention descriptions specify different glucose thresholds and targets, but the intensive-arm text is incomplete: it ends after the target range begins with between 80. No missing target value should be inferred. Other details of treatment delivery, adherence, co-interventions, or actual glucose levels are not reported in the registry record. The record also does not report a statistical analysis plan, a sample-size justification, or whether any interim analysis was planned.
Thus, the design describes a randomized comparison, but the available record is not a completed efficacy report. Its trial status, incomplete treatment description, and absence of primary outcome analysis are central to interpreting what can be learned from it.
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: Subjects were randomized to a specific study arm based on a computer generated randomization table. 49 participants are included in the baseline characteristic module because although 56 signed consent, some subjects withdrew the consent prior to study procedures and several withdrawn by attending anesthesiologist.
Overall Study
| Stage | Conventional Glycemic Control | Intensive Glycemic Control |
|---|---|---|
| STARTED | 30 | 26 |
| COMPLETED | 28 | 21 |
| NOT COMPLETED | 2 | 5 |
Reasons for not completing this period:
| Reason | Conventional Glycemic Control | Intensive Glycemic Control |
|---|---|---|
| Adverse Event | 0 | 1 |
| Physician Decision | 0 | 1 |
| Withdrawal by Subject | 2 | 3 |
Analysis population for the primary outcome, as defined in the registry: no analysis was done as the study was terminated due to patient safety concerns
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: males and females between the ages of 18 and 89.
| Characteristic | Unit | Conventional Glycemic Control | Intensive Glycemic Control | Total |
|---|---|---|---|---|
| Participants analysed | 28 | 21 | 49 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 25 | 20 | 45 |
| Age, Categorical: >=65 years | Participants | 3 | 1 | 4 |
| Sex: Female, Male: Female | Participants | 12 | 13 | 25 |
| Sex: Female, Male: Male | Participants | 16 | 8 | 24 |
6. Primary Endpoint
The registry lists the primary outcome as Wound Infection, measured over 7-10 days post op.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was wound infection, with assessment specified at 7-10 days post op. A wound infection is a clinically observable complication following surgery. In general, such an endpoint can be used to compare the frequency of a defined postoperative outcome between treatment groups, provided that the outcome is measured consistently and the analysis population and follow-up are adequately described.
The registry's rationale focuses on whether peri-operative glucose management is associated with altered morbidity and mortality among patients undergoing non-cardiac major surgery. Wound infection represents a morbidity outcome in that context. The record does not provide a detailed definition of wound infection, diagnostic criteria, assessment procedures, or information about who assessed the outcome. It also does not state whether the endpoint was measured as a count, a proportion, or another summary in the planned analysis.
Most importantly, the registry explicitly says no analysis was done because the study was terminated due to patient safety concerns. It therefore reports no comparative wound-infection result, effect estimate, or measure of precision. The presence of a named primary endpoint indicates what the study intended to assess; it is not evidence that the endpoint was evaluated or that the arms differed.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record establishes that the study was designed as a randomized, open-label, parallel-group comparison of intensive and conventional peri-operative glycemic control. It also identifies wound infection at 7-10 days post op as the primary outcome. Those details explain the intended comparison, but the record does not report a primary outcome analysis. There is consequently no estimated difference between arms, no confidence interval, and no inferential result for wound infection to interpret.
The registry gives a specific reason for the absence of the analysis: the study was terminated due to patient safety concerns. That statement is important for understanding why results are incomplete. It does not identify the nature of the concerns or establish that they were caused by one of the treatment strategies. The record contains no account of the events leading to termination, and no basis for assigning a cause or judging the balance of benefits and harms.
The safety figures are descriptive counts, not a substitute for the missing primary outcome analysis. Serious adverse events are recorded as zero in both arms. Other adverse events are recorded as zero in the conventional arm and one in the intensive arm. The listed arm-specific numbers at risk are 28 for conventional control and 21 for intensive control. The record does not provide further detail about the event recorded in the other-adverse-event category, its timing, severity, or relationship to treatment. Deaths are not reported in the safety record.
The randomized design would ordinarily support a comparison of outcomes between groups, but randomization alone cannot answer the research question when the planned outcome analysis is absent. Nor do the adverse-event counts establish that one strategy is safer: the counts are limited, event descriptions are missing, and the registry gives no comparative safety analysis. The difference between the listed arm denominators and the stated enrollment also is not explained in the record, so the relationship of the safety populations to all enrolled participants remains unclear.
No treatment effect should be inferred from the absence of a reported result. A missing analysis is not evidence that the groups had equal outcomes, and the safety counts do not reveal the wound-infection outcomes. The defensible interpretation is that this registry record documents a terminated trial and a planned endpoint, but does not supply the comparative clinical result needed to answer the primary question.
9. Statistical Methods Explained
What does randomization contribute?
In general, randomization assigns participants to treatment groups by chance. If assignment is implemented as intended, it can reduce systematic differences between groups at baseline, including differences that are difficult to measure. This makes a between-group outcome comparison more interpretable than a comparison in which treatment choice is determined by participant characteristics or clinician judgment. Randomization does not guarantee that every group characteristic will be identical, and it does not replace outcome measurement or analysis.
The registry classifies this study as randomized and parallel-group. A parallel-group design means the listed treatment strategies are compared in separate groups rather than by having each participant receive both strategies in sequence. The record does not report the sequence-generation method, allocation concealment, or other implementation details. It also does not report an analysis of baseline characteristics. These details therefore cannot be used to judge how randomization was carried out or whether the recorded groups were comparable.
What does open-label mean for interpretation?
The masking entry is none, so the record describes the trial as unmasked. In general, this means participants and study personnel may know which treatment strategy is assigned. Knowledge of assignment can affect treatment delivery, additional care, reporting, or outcome assessment, depending on the endpoint and study procedures. It does not automatically invalidate a result, but it makes clear outcome definitions and consistent assessment particularly relevant. The registry does not describe who assessed wound infection or whether any assessment procedures reduced the possibility that knowledge of treatment influenced measurement.
The endpoint is wound infection, with a stated assessment time of 7-10 days post op. The registry does not report operational criteria for determining that an infection occurred, nor does it state how incomplete or missed assessments would be handled. Without those details, a reader cannot evaluate endpoint ascertainment or determine how the planned analysis would have treated unavailable outcome data.
What would an effect estimate and confidence interval usually show?
In general, an effect estimate describes the observed contrast between groups for an outcome. Its interpretation depends on the outcome scale and on how the comparison is defined. A confidence interval conveys uncertainty around an estimate: a narrower interval indicates greater precision, while a wider interval indicates less precision. A confidence interval is not a guarantee that the true effect lies within its limits, and it does not by itself establish clinical importance.
There is no wound-infection effect estimate or confidence interval in this registry record because the primary outcome was not analyzed. No confidence interval can therefore be used to judge either the direction or precision of a treatment contrast. Similarly, no p-value for the primary endpoint is reported. It would be inappropriate to substitute the adverse-event counts for an estimate of the primary endpoint or to describe the unreported outcome as statistically significant or not significant.
What is the role of analysis populations and missing data?
In general, a trial report should define which participants are included in each analysis and how outcomes that were not observed are handled. Different analysis populations can answer different questions. For example, a comparison based on assigned treatment can preserve the benefits of randomization, while an analysis limited to participants who followed treatment can introduce differences between groups. These are general considerations, not descriptions of an analysis performed in this study.
The registry states that no analysis was done for the primary outcome. It does not report a primary analysis population, the number of participants with wound-infection assessments, or a missing-data method. Although the safety record lists numbers at risk for adverse events, those counts do not establish who would have been included in an analysis of wound infection. The record also does not explain the relationship between those safety counts and the enrollment figure.
What can be concluded from the posted safety counts?
Counts of events and numbers at risk can describe what was recorded in a particular safety category, but their interpretation depends on definitions, follow-up, and completeness of ascertainment. Here, the record lists zero serious adverse events in each arm and reports one other adverse event in the intensive arm and none in the conventional arm. It does not provide event descriptions or an analysis comparing safety between arms. Deaths are not reported. These limited data do not establish a treatment effect on safety.
Was a statistical analysis plan reported?
The registry record does not report the statistical methods intended for the primary endpoint. It does not identify a model, test, adjustment strategy, or approach to handling repeated or multiple outcomes. It also does not report a sample-size justification or interim-analysis plan. General statistical methods can explain how such choices matter, but they cannot be attributed to this study without documentation. The absence of a reported analysis plan is especially consequential because the primary analysis was not conducted, leaving no estimate or uncertainty measure to assess.
10. Multiplicity, Missing Data and Analysis Populations
The record lists wound infection as the primary outcome and hemodynamic instability as a secondary outcome. It does not report a statistical analysis plan describing how these outcomes would be analyzed, whether there were additional planned outcomes, or whether any adjustment for multiple comparisons was intended. The number of outcome measures listed in the record does not provide enough information to infer a multiplicity strategy.
In general, when several outcomes or several comparisons are tested, the chance of obtaining at least one apparently notable result by chance can increase. Prespecified outcome priorities and multiplicity procedures can help readers distinguish a primary test from exploratory analyses. No such procedures are reported for this trial, and no outcome analysis was conducted according to the registry description. It is therefore not possible to assess the impact of multiplicity on a reported treatment result.
Missing-data methods are also not reported. The registry does not give the number of participants with an observed wound-infection assessment, explain whether any assessments were unavailable, or describe a method for handling missing outcomes. The safety counts do not resolve these questions because they refer to adverse-event reporting, not to the primary endpoint analysis.
The registry reports enrollment of 56, while the arm-specific safety denominators are 28 and 21. It does not explain the relationship between these figures, identify an analysis population, or say whether any participants were excluded from safety reporting. No total or implied analysis count should be inferred from them. The study's termination and lack of a primary analysis further limit assessment of missingness, analysis populations, and multiplicity. These are unreported aspects of the record, not evidence that any particular statistical procedure was or was not used outside what the record states.
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 |
|---|---|---|---|
| Conventional Glycemic Control | 0 | 28 | 0.0% |
| Intensive Glycemic Control | 0 | 21 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Conventional Glycemic Control | 0 of 28 |
| Intensive Glycemic Control | 1 of 21 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Conventional Glycemic Control | Intensive Glycemic Control |
|---|---|---|---|
| hypoglycemia | Endocrine disorders | 0 of 28 | 1 of 21 |
The registry lists zero serious adverse events among 28 at risk in the conventional glycemic control arm and zero among 21 at risk in the intensive glycemic control arm. It also lists zero other adverse events in the conventional arm and one among 21 at risk in the intensive arm. These are descriptive counts in the posted safety record; they are not a comparative estimate of treatment effect.
The record does not describe the other adverse event or provide its timing, clinical details, severity, or assessed relationship to the intervention. The serious adverse event terms list is empty, and deaths are not reported in the safety results. The record also does not explain why the listed safety denominators differ from the stated enrollment, or whether the adverse-event reporting covers all participants over the same follow-up period.
Zero recorded serious events in these arms should not be interpreted as proof that serious events could not occur, nor does the single other event establish that the intensive strategy caused harm. The study was terminated due to patient safety concerns, but the registry does not identify those concerns or link them to a particular event or arm. The available figures therefore need to be read alongside the substantial gaps in event detail and the absence of a reported safety analysis.
12. What the Result Does, and Does Not, Mean
This record is useful for identifying the study's intended clinical comparison: intensive versus conventional glycemic control during the peri-operative period for patients undergoing non-cardiac major surgery. It records a randomized, parallel-group design without masking, names wound infection as the primary outcome, and gives the planned assessment time as 7-10 days post op. It also records hemodynamic instability as a secondary outcome.
What the record does not provide is the result needed to answer whether the groups differed in wound infection. The primary outcome was not analyzed because the study was terminated due to patient safety concerns. There is no reported effect estimate, confidence interval, or primary-outcome significance test. The record therefore cannot support a conclusion that intensive control improved, worsened, or had no effect on the primary endpoint.
The safety information is similarly limited. The recorded serious adverse event counts are zero in both arms, while the other-adverse-event counts are zero in the conventional arm and one in the intensive arm. The event itself is not described, deaths are not reported, and no comparative safety analysis is given. The reason for termination is stated at a high level, but the events or decision process behind that reason are not reported. It would be unwarranted to interpret the termination as proof that a particular treatment caused a specific harm.
More broadly, a randomized design is a framework for making a fair comparison, not a result in itself. When the planned endpoint is not analyzed, the design cannot establish the direction or precision of an outcome difference. Nor should an absent result be treated as evidence of equivalence. The registry is informative about the trial's question, design, status, and selected safety counts, while leaving the central comparative clinical question unanswered.
13. Why This Trial Matters Statistically
This trial matters statistically because it illustrates the distinction between a study design and an analyzed result. Random assignment can support a credible comparison when outcomes are measured and analyzed, but the registry states that no analysis was done for the primary endpoint. The presence of a randomized design does not create an effect estimate where none was reported.
The record also highlights why outcome definition and follow-up matter. Wound infection was named as the primary outcome and a postoperative assessment interval was specified, but the registry does not provide diagnostic criteria or assessment procedures. Those details affect how consistently an endpoint can be measured and how readers judge the comparability of its ascertainment, particularly in an unmasked study.
Termination adds another statistical and interpretive complication. The registry attributes termination to patient safety concerns without describing their nature or timing. This limits the ability to understand why the study stopped, what information was available at that point, or whether a particular treatment group or event was implicated. The record does not report an interim-analysis plan, so no such plan can be assumed.
Finally, the safety counts show why small descriptive event summaries must not be mistaken for a full analysis. The event descriptions, deaths, follow-up details, and analysis populations are not sufficiently reported to support a treatment comparison. Taken together, the record is a clear example of how trial registration can preserve information about a research question and design even when the outcome analysis needed to answer that question is unavailable.
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 is explicit in the registry: no analysis was done for the primary outcome because the study was terminated due to patient safety concerns. There is no reported wound-infection result, estimate of uncertainty, or analysis of the secondary outcome. The reason for termination is not described beyond the safety concern, so its source and implications cannot be assessed from this record.
The intervention description is incomplete. The intensive-arm text ends after stating that glucose would be maintained between 80, without reporting the other end of the target range. The record also does not describe actual glucose levels, treatment adherence, or other details that would show how the assigned strategies were delivered in practice.
Outcome reporting is limited. The registry does not define wound infection, give assessment procedures, or report the number with an observed primary outcome. It does not report a missing-data approach, analysis population, statistical model, or adjustment plan. The record names hemodynamic instability as a secondary outcome but gives no result for it.
The safety record lists arm-specific denominators that are not explained in relation to enrollment. It provides no description of the one other adverse event, does not report deaths, and lists no serious adverse event terms. The duration and completeness of safety follow-up are not described. These limitations prevent a detailed assessment of safety as well as efficacy.
The record also does not report a sample-size justification, interim-analysis plan, allocation-concealment method, or details of how randomization was implemented. These are unreported aspects of the registry record and should not be filled in by assumption.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: The Association Between Peri-Operative Hyperglycemia and Major Morbidity and Mortality — NCT00487162.
- Registry record last updated 2016-11-08; status last verified 2016-09.
- Results first posted 2014-04-03.
- 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 describes a randomized, open-label, parallel-group study of intensive versus conventional peri-operative glycemic control in non-cardiac major surgery patients. Enrollment is listed as 56. The primary endpoint was wound infection at 7-10 days post op, and hemodynamic instability was listed as a secondary outcome.
The study status is terminated. The primary outcome description states that no analysis was done because of patient safety concerns. No comparative primary or secondary outcome results are reported. Safety counts list zero serious adverse events in both arms, zero other adverse events in the conventional arm, and one other adverse event in the intensive arm. Deaths are not reported. The registry does not describe the event behind the safety concern or provide enough analysis detail to establish a treatment effect.