High MAP in Septic Shock With Hypertension: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for High MAP in Septic Shock With Hypertension (NCT01443494), a na na study. The primary outcome is Mean Arterial Pressure.

2. Clinical Question

The clinical question concerns a targeted change in blood pressure for patients with septic shock and previous hypertension. Each patient’s usual MAP was intended to serve as the target. The record says this level was estimated from the average MAP in physical examination records from the last two years; if records were incomplete, the target was obtained by detailed enquiry with the patient’s next of kin.

The intervention description focuses on titrating NE to that target, not on comparing the target strategy with a separate treatment group. Perfused Vessel Density is listed as a secondary outcome, but its results are not reported in the registry record. Thus, the registry describes the question and planned measurement approach, but does not provide results with which to evaluate the stated microcirculation hypothesis.

3. Trial Design

This completed study is registered as a single-group study with an enrollment of 19. Its condition is septic shock, and the intervention is listed as NE. The allocation is recorded as NA and masking as none. No randomized allocation or concurrent control group is described, so the design does not support a direct between-group treatment comparison.

The intervention description says NE doses were adjusted after EGDT to titrate MAP to the participant’s usual level, regardless of fluid responsiveness. The usual level was based on the average MAP in physical examination records from the last two years, with enquiry to next of kin used when records were incomplete. After basal hemodynamic and microcirculatory measurements, the NE doses were increased toward the target; participants were allowed to stabilize before new measurements were taken. The primary outcome timeframe is target MAP stabilization for 30 min.

The registry status is completed. The study start is recorded as 2011-06 and primary completion as 2012-06. Phase is listed as NA. The sponsor is Southeast University, China. These registry entries describe the study’s status and administrative record, but do not establish how participants were selected or whether all enrolled participants contributed measurements.

The registry lists two outcome measures and zero analyses. It does not report a formal statistical plan, a sample-size justification for the enrolled group, or details of interim analyses. The sample-size assumptions associated with planning illustrations describe a hypothetical two-arm calculation, whereas this study is single-group. Those assumptions should not be read as the study’s design or as evidence that the study had a particular planned power.

Because there is no control group, any within-study change would need to be interpreted as a change observed over time in this group, not as an isolated causal effect of the intervention. The registry record does not report the numerical primary outcome results or the analysis used to assess change.

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.

Overall Study

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: Detailed enquiry about the target MAP to their next kin was performed in all of the patients.

6. Primary Endpoint

The registry lists the primary outcome as Mean Arterial Pressure, measured over Target MAP stabilization for 30 min.

The registered primary endpoint is mean arterial pressure (MAP), measured in mmHg and summarized as a mean with standard deviation. The timeframe is target MAP stabilization for 30 min. MAP is the blood-pressure target used in the intervention: NE was adjusted toward the participant’s estimated usual MAP.

The registry description explains how the target was identified. For patients with previous hypertension, the average MAP in physical examination records from the last two years was taken as the usual level. If those records were incomplete, the target was elicited from the patient’s next of kin. This approach makes the individual’s estimated usual pressure the reference for titration.

MAP is directly relevant to whether the intended pressure target was reached and stabilized. The study’s stated hypothesis concerns sublingual microcirculation, and Perfused Vessel Density is listed as a secondary outcome. The primary endpoint is nevertheless MAP, not a direct measure of microcirculation. The registry record does not report a primary MAP mean, standard deviation, baseline-to-target change, or statistical test result. It therefore documents what was measured and when, but does not quantify the observed endpoint.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies MAP as a continuous outcome, with a mean and standard deviation as its summary measures. A continuous outcome can take values across a scale rather than being limited to categories. A mean describes the central level of the recorded measurements, while a standard deviation describes how spread out those measurements are around the mean. These are general statistical interpretations of the stated summary format; the registry record does not give the actual MAP mean or standard deviation.

What would a confidence interval communicate?

In general, a confidence interval presents a range of values compatible with an estimate under the method used to calculate it. Its width conveys precision: a narrower interval indicates greater precision, while a wider interval indicates more uncertainty. The interval does not guarantee that the true value lies within it, and it does not replace an assessment of study design or data quality. No confidence interval for MAP or Perfused Vessel Density is reported in the registry record.

What does a single-group design mean for analysis?

In general, a single-group study can describe measurements within the enrolled group, including measurements taken at different times if those are collected. Without a concurrent control group, it cannot make a direct randomized comparison between alternative strategies. Observed changes may coincide with the intervention, but a single-group design alone cannot distinguish the intervention from other changes occurring over the same period. The registry records a single-group model and does not describe a control arm.

The record describes basal hemodynamic and microcirculatory measurements before NE doses were increased to titrate MAP toward the target, followed by new measurements after stabilization. It does not report the numerical measurements at either time point or the method used to compare them. The timeframe for the primary MAP outcome is target MAP stabilization for 30 min; the description also says participants were allowed to stabilize for 30 min before new measurements. The registry does not clarify how repeated measurements were combined for analysis.

Why do dispersion and uncertainty matter?

General statistical interpretation requires both an estimate and information about its variability. A mean alone does not show whether participant measurements were tightly grouped or widely spread. A standard deviation describes observed spread, while a confidence interval addresses uncertainty in an estimated quantity under a specified method. Neither the primary outcome’s standard deviation nor an inferential estimate is reported, so the variability and precision of the outcome cannot be evaluated.

For count outcomes, sparse or zero counts can make estimates especially uncertain. General methods for rare events may need to account for the small amount of information in the data rather than treating a zero observed count as proof that the underlying event risk is zero. The registry’s serious-event counts should therefore be read as recorded counts, not as a precise estimate of risk.

What do the planning assumptions represent?

The planning assumptions describe a general sample-size illustration based on an observed effect, with two-sided significance level 0.05, equal allocation between two arms, and a normal approximation. For time-to-event outcomes, the assumption describes total events; for other outcomes, it describes participants per arm. These are planning conventions, not observed trial results and not evidence of observed power.

Those assumptions do not match the registered single-group design, which has no stated two-arm allocation. The registry record does not report the specific effect used for a planning illustration, a study-specific sample-size justification, or planned sample-size counts. Because the numerical primary outcome results are not reported, the observed effect cannot be assessed from the record. A sample-size illustration cannot substitute for an analysis of the actual participants or establish whether the study’s results are precise.

What can be concluded from the analysis record?

The registry lists zero analyses. It does not specify a statistical test, model, covariate adjustment, confidence-interval method, or approach to repeated measures. It also does not report an analysis population or missing-data strategy. Without those details and without numerical outcome results, the posted record supports a methodological description but not a reconstruction of the inferential analysis. General statistical concepts explain what such methods would address; they do not fill in methods or results that are not reported in the registry record.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Septic Shock Patients Despite EGDT")
n   <- c(19)
m   <- c(90)
sp  <- c(7)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Septic Shock Patients Despite EGDT  19  90.000  7.000  86.626  93.374

11. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures: the primary MAP endpoint and Perfused Vessel Density as a secondary outcome. It records zero analyses. No multiplicity strategy is reported in the registry record. In general, when multiple outcomes are tested, multiplicity methods address the increased chance of finding at least one apparently notable result by chance. Whether that issue affected interpretation in this study cannot be assessed without reported tests and an analysis plan.

The registry record does not state how missing measurements were handled, whether any participants lacked endpoint data, or whether an intention-to-treat, per-protocol, or other analysis population was used. Enrollment of 19 does not establish how many participants contributed to a particular outcome analysis. The outcome-specific analysis counts are not reported in the registry record.

For a continuous measure such as MAP, missingness can affect both the estimate and its precision. General approaches may include analyzing available observations or using a model or imputation method, but the appropriate approach depends on the data and assumptions. None of these methods is identified for this study. The reason for any missing observations and whether missingness was related to participant status are also not reported in the registry record.

The registry’s zero analyses entry should be read as an absence of analyses recorded in the registry, not as proof that no analysis was ever conducted outside the record. The posted results do not permit evaluation of multiplicity control, missing-data handling, or the population used for inference.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry records a serious adverse event group titled “Septic Shock Patients Despite EGDT.” In that group, 19 participants were at risk and zero were affected by the recorded serious-event count. For the other-event count, 19 were at risk and zero were affected. These are reported counts and denominators, not estimates from a comparative safety analysis.

The deaths entry is null. A death count is therefore not reported in the registry record; null should not be interpreted as zero deaths. The record also lists no serious-event terms. It does not provide further event definitions, follow-up detail, or a comparison group against which to interpret the counts.

In general, zero recorded events in a small study do not establish that the underlying risk is zero. The counts provide limited information about uncommon events, and the absence of a control group prevents a comparative assessment. The safety entries should be read narrowly as the events recorded in this registry record, not as proof of safety or as evidence about events that were not reported.

13. What the Result Does, and Does Not, Mean

The registry record establishes that a completed single-group study enrolled 19 participants with septic shock and used NE titration toward an individually estimated usual MAP after EGDT. It describes MAP as the primary outcome and Perfused Vessel Density as a secondary outcome. It also records a hypothesis about increasing MAP from 65 mmHg to the usual level and improving sublingual microcirculation.

Those details explain the study’s rationale and approach, but they are not outcome evidence. The registry does not report the primary MAP mean, standard deviation, or change, and it does not report a result for Perfused Vessel Density. There is no reported confidence interval or statistical test result. The effect’s size, direction, and precision therefore cannot be determined from the posted results.

The study is single-group, with no concurrent comparator described. General statistical reasoning cautions that change observed over time in one group cannot on its own distinguish the intervention’s contribution from other influences. The registry record also does not report the analysis method, the number of participants with usable outcome data, or the handling of missing measurements.

The serious adverse event entries show zero affected participants among 19 at risk for the listed counts, while the deaths value is not reported in the registry record. Those entries do not establish that no events occurred beyond what was recorded, and they do not provide a comparative safety estimate.

Accordingly, the posted record supports describing the target-setting procedure, enrolled group, outcome definitions, and recorded event counts. It does not establish whether the stated microcirculation hypothesis was supported, quantify an effect, or demonstrate that the target strategy caused a change. These conclusions would require results and analysis details that are not reported in the registry record.

14. Why This Trial Matters Statistically

This trial is statistically notable because its clinical hypothesis concerns microcirculation, while its registered primary endpoint is MAP. MAP is central to the titration target, but it is not itself the listed secondary measure of Perfused Vessel Density. Keeping the hypothesis distinct from the primary endpoint helps clarify what the registry set out to measure and what evidence would be needed to address the biological question.

The study’s individual target is based on a retrospective estimate of each participant’s usual MAP, using records from the last two years or enquiry with next of kin when records were incomplete. This creates an outcome and intervention context in which the target is individualized. The registry describes that procedure, but does not report how target estimates were distributed or how many were obtained through each route.

The single-group model also matters statistically. It can describe measurements collected during the intervention process, but does not provide a concurrent reference group for separating changes associated with titration from other influences. This design feature should shape interpretation regardless of whether a within-group change is reported.

Finally, the registry record contains enrollment and event counts but no numerical primary outcome results or analysis. This illustrates why a study description, an outcome definition, and a statistical result are distinct kinds of information. Without an estimate and its uncertainty, readers cannot assess the magnitude or precision of the primary outcome. The record can inform readers about the study question and design, while leaving the central outcome question unanswered.

15. 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 registry record does not report the numerical results for the primary MAP endpoint or the secondary Perfused Vessel Density outcome. It also does not provide measures of variability, confidence intervals, or test results. The central limitations for interpreting efficacy are therefore lack of outcome estimates and lack of inferential detail.

The study is registered as single-group, with allocation NA and no masking. No concurrent control group is described. Any within-group measurements would not supply a randomized comparison, and the record does not report an analysis that could address the absence of a comparator.

The primary outcome timeframe is target MAP stabilization for 30 min, but the record does not state how many measurements contributed to each participant’s endpoint or how repeated measurements were summarized. It does not report the number with complete measurements, missing-data reasons, or the analysis population. The approach to selecting or estimating each participant’s usual MAP is described, but the record does not report the completeness of the underlying records or how often next-of-kin enquiry was needed.

The registry lists two outcome measures and zero analyses, but does not specify an analysis plan or a multiplicity approach. The sample-size assumptions describe a hypothetical two-arm planning illustration, not the registered single-group design; a study-specific sample-size justification is not reported in the registry record.

Safety interpretation is also constrained by the small enrolled group, the absence of a comparator, and the lack of additional event detail. Deaths are not reported as a numerical count. These limitations are specific to the information recorded and should not be replaced with assumptions about unreported methods or results.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: High MAP in Septic Shock With Hypertension — NCT01443494.
• Registry record last updated 2017-07-06; status last verified 2017-06.
• Results first posted 2014-06-16.
• 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.

19. Record Summary

This completed single-group study enrolled 19 participants with septic shock. NE was titrated after EGDT toward each participant’s estimated usual MAP, regardless of fluid responsiveness. The registry lists no masking and no randomized allocation.

The primary outcome is mean MAP in mmHg, summarized as a mean and standard deviation after target MAP stabilization for 30 min. Perfused Vessel Density is listed as a secondary outcome. The stated hypothesis concerns improvement in sublingual microcirculation when MAP is increased from 65 mmHg to the participant’s usual level.

The registry does not report numerical outcome results, analysis methods, missing-data handling, or a study-specific sample-size justification. It records zero analyses. Serious and other adverse event counts each show zero affected among 19 at risk; deaths are not reported in the registry record. The posted information describes the study design and measurements but does not establish the direction, magnitude, or precision of an outcome effect.