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 Intraoperative Glucose Control in Liver Transplant (NCT00780026), a randomized phase 4 study. The primary outcome is Infection Rates.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00780026 |
| Phase | Phase 4 |
| Condition | Liver Transplant |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 100 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Michigan |
| Results posted | Yes |
2. Clinical Question
Population
People undergoing liver transplantation. The registry record describes the study as evaluating postoperative outcomes following transplantation, but does not provide further eligibility details or a more specific description of the population analyzed for the primary endpoint.
Intervention
Strict intraoperative glycemic control using insulin, described as maintaining glucose at 80 to 110 mg/dl.
Comparator
Standard of care insulin dosing during the operation. The registry record does not describe the glucose targets or dosing algorithm for this comparator.
Primary question
Does strict, rather than standard, intraoperative glycemic control change the number of participants who sustain an infection after surgery, assessed at 30 days?
The broader stated objective also concerns recipient survival at 1 year and surgical complications, including infections. However, the primary endpoint listed in the registry record is infection rates, measured as the number of participants with an infection after surgery at 30 days. These objectives should not be conflated: a stated objective is not itself a reported result, and the listed primary endpoint does not provide a numerical estimate of the survival comparison.
The trial addresses a comparison between two approaches to insulin management during liver transplantation. It is not a comparison of insulin with no insulin: both arms involve insulin, with strict glycemic control contrasted with standard care insulin dosing. The registry record identifies the central question but does not provide arm-specific primary infection results, an effect estimate, or a measure of uncertainty. Therefore, the registry information available for this analysis establishes what was asked, but does not establish the size or direction of the primary-outcome result.
3. Trial Design
The registry describes a randomized, prospective, parallel-group trial with no masking. It lists the phase as PHASE4 and the enrollment as 100. The study status is COMPLETED. The recorded start is 2008-07 and the primary completion is 2009-09. The sponsor is University of Michigan.
The two groups are named Strict Glycemic Control and Standard of Care Control. The strict-control arm is described as insulin-based control at 80 to 110 mg/dl. The comparator is described as standard of care insulin dosing. Because both arms use insulin, the intended contrast is between glucose-management strategies rather than insulin exposure versus no insulin exposure. The record does not state the comparator’s glucose target or provide further details about dosing, monitoring, or how treatment adherence was assessed.
Random allocation is intended to make the groups comparable, on average, with respect to factors that could influence outcomes. That principle does not guarantee that the groups will be identical in a particular trial. The registry record does not report the method used to generate the allocation sequence, whether allocation was concealed, or any baseline characteristics with which to assess group comparability. With no masking, participants and study personnel were not described as blinded; the record does not specify whether outcome assessors or analysts were masked.
The study lists seven outcome measures and ten analyses. The record identifies secondary outcomes that include hospital length of stay, postoperative blood transfusion within three days in the ICU, hemodialysis, biliary complications, and venous thrombotic complications. It does not provide enough information to determine which analyses correspond to each outcome or the exact analysis populations. A detailed protocol and the statistical analysis plan are 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.
Overall Study
| Stage | Strict Glycemic Control | Standard of Care Control |
|---|---|---|
| STARTED | 50 | 50 |
| COMPLETED | 50 | 50 |
| NOT COMPLETED | 0 | 0 |
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.
| Characteristic | Unit | Strict Glycemic Control | Standard of Care Control | Total |
|---|---|---|---|---|
| Participants analysed | 50 | 50 | 100 | |
| Age, Continuous | years | 54 (48 to 57) | 55 (50.0 to 59.0) | 54 (49.0 to 59.0) |
| Sex: Female, Male: Female | Participants | 38 | 36 | 74 |
| Sex: Female, Male: Male | Participants | 12 | 14 | 26 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 5 | 4 | 9 |
| Race (NIH/OMB): White | Participants | 41 | 41 | 82 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 4 | 4 | 8 |
| Race/Ethnicity, Customized: White | Participants | 41 | 41 | 82 |
| Race/Ethnicity, Customized: African American | Participants | 5 | 4 | 9 |
| Race/Ethnicity, Customized: Asian | Participants | 0 | 1 | 1 |
| Race/Ethnicity, Customized: Other | Participants | 4 | 4 | 8 |
| Region of Enrollment: United States | Participants | 50 | 50 | 100 |
| BMI | kg/m2 | 30.4 (25.7 to 35.9) | 28.9 (25 to 32.4) | 29.6 (25.1 to 34.0) |
| Pre-existing conditions: Diabetes | Participants | 13 | 16 | 29 |
| Pre-existing conditions: Coronary Artery Disease(CAD) | Participants | 4 | 4 | 8 |
6. Primary Endpoint
The registry lists the primary outcome as Infection Rates, measured over 30 days.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is titled Infection Rates and is measured as the number of participants who sustained an infection after surgery. The stated timeframe is 30 days. This is a binary participant-level outcome for each individual: a participant either had an infection recorded within the endpoint definition or did not. The registry describes the endpoint as a count of participants, rather than the number of separate infection episodes.
In general, an infection endpoint can summarize a clinically relevant postoperative complication in a form that can be compared between randomized groups. Counting participants with an event avoids treating repeated infections in the same person as if they were separate participants, although it does not convey the number, type, severity, or timing of infections beyond the stated assessment window. The registry record does not provide further details about which infections qualified, how they were confirmed, or how events were adjudicated.
The registry record does not report arm-specific event counts, an effect estimate, or a confidence interval for this endpoint. It also does not give a numerical result for the stated 1-year survival objective. The endpoint definition therefore clarifies what the trial intended to measure, but the available record does not support a conclusion about the observed infection comparison.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The principal interpretive limitation is that the registry record identifies the primary endpoint but does not report its numerical results. It gives no arm-specific counts of participants with infection at 30 days, no estimated contrast between strict and standard control, and no confidence interval or p-value for that comparison. The direction, magnitude, and statistical precision of the primary result therefore cannot be established from the recorded information.
The stated study objective includes 1-year recipient survival and postoperative complications, including infection. These aims do not substitute for outcome results. The listed secondary outcomes include hospital length of stay and several complications, but the record does not provide their numerical findings. In particular, deaths recorded in the safety information should not be read as the trial’s 1-year survival comparison: the safety counts do not specify that survival endpoint’s timeframe or analysis.
General statistical context: an effect estimate describes the contrast between groups, while a confidence interval indicates the range of values compatible with the data under the method used. A p-value, when reported, addresses how compatible the data are with a specified null model; it does not measure clinical importance or the probability that the null hypothesis is true. None of these primary-outcome statistics is reported in the registry record, so they cannot be used to judge either the size of the infection contrast or its precision.
The registry does report safety-event counts for each arm. For serious adverse events, it lists 16 affected participants among 50 at risk in Strict Glycemic Control and 11 among 50 at risk in Standard of Care Control. For other adverse events, it lists 45 affected participants among 50 at risk in Strict Glycemic Control and 42 among 50 at risk in Standard of Care Control. The recorded death counts are 12 and 9, respectively. These are safety-record figures, not a substitute for the primary infection result, and the record does not clarify their relationship to the endpoint populations or analysis windows.
No treatment effect should be inferred from these counts alone. The record does not give the definitions used for the safety categories, whether participants could contribute to more than one category, or statistical comparisons for these figures. In addition, the registry record does not report a detailed analysis plan, missing-outcome counts, or analysis populations. The posted information thus supports a description of the trial and its listed safety figures, but not a complete assessment of the primary efficacy question.
9. Statistical Methods Explained
General statistical context. A randomized trial compares outcomes across groups assigned to different strategies. Random allocation is useful because, in expectation, it distributes both measured and unmeasured prognostic factors across the groups. In an individual trial, chance imbalances can remain. The registry record says the study was randomized, but does not report how the sequence was generated or how assignments were concealed. Without those details, the precise safeguards against selection bias cannot be assessed from the record.
What does a participant-count endpoint represent?
The primary endpoint is a count of participants who experienced an infection after surgery within the stated 30-day timeframe. In general, this can be analyzed as a binary outcome at the participant level. A comparison might describe the proportion of participants with an event in each arm, or estimate a difference or ratio between those proportions. Those are general ways to express binary-outcome effects; the registry record does not identify which measure was used for the primary analysis or supply the information needed to reproduce one.
Participant-level counts are not the same as counts of all infection episodes. A person with repeated infections may still contribute as a participant with an event under a binary definition. The registry’s brief endpoint description does not specify whether repeat events were handled separately, how infections were defined, or whether a review process confirmed them. These details can affect interpretation and reproducibility.
What do uncertainty measures tell readers?
General statistical context. An effect estimate gives a numerical summary of the group contrast. A confidence interval communicates uncertainty around that estimate under the statistical model and assumptions used. A narrow interval indicates greater precision than a wide one, but precision alone does not determine clinical relevance. A p-value assesses compatibility with a specified null hypothesis; it does not describe the size of an effect, establish causation by itself, or tell readers the probability that a result is true.
The registry record does not report a primary-outcome effect estimate, confidence interval, or p-value. Consequently, readers cannot assess the estimated direction, the plausible range of effects, or how the primary result relates to a null comparison from this record. The absence of these statistics should not be interpreted as evidence that there was no effect or that a comparison was statistically significant.
What can the safety counts show?
The record separates serious adverse events from other adverse events and lists the number at risk and affected in each arm. General caution is needed when reading such categories. Affected-participant counts do not necessarily represent event episodes, and the same participant may potentially appear in more than one category or term. The registry record does not state whether categories overlap, explain the event definitions, or give a comparative statistical model. It is therefore appropriate to report the entries as recorded without turning them into a calculated risk contrast or a causal conclusion.
The record also lists deaths within the safety information. A safety death count is not automatically equivalent to a prespecified survival endpoint. For a survival analysis, the timing of events and follow-up, censoring, and analysis population can matter. Those details and a numerical result for the stated 1-year survival objective are not reported in the registry record.
How should planning calculations be understood?
General statistical context. A sample-size calculation is a planning exercise. It asks how much information a future study might need under specified assumptions about the effect to detect, variability, significance level, allocation, and analysis method. It is not a result of the trial and does not show the probability that this completed trial detected an effect. A calculation based on an observed effect can be especially sensitive to the estimate chosen, because an uncertain observed estimate is not a guaranteed effect in a new study.
The registry describes its sample-size assumptions as a planning illustration based on the observed effect, with two-sided significance level 0.05, equal allocation, and a normal approximation. It states that time-to-event calculations use total events, while other calculations use participants per arm. The illustration is not described as the trial’s original design justification. Numerical planning results and the effect fractions used are not reported in the registry record available for this analysis. These calculations should therefore be understood as hypothetical planning scenarios, not observed power or evidence about the primary trial result.
Over-dispersion is a general concern when count outcomes vary more than a statistical model assumes. It can make standard errors too small if the model fails to account for the extra variability. The primary endpoint is described as participants with an event, rather than a repeated-event count with a stated dispersion parameter. The registry record does not report a model or variance assumption for the primary analysis, so it is not possible to assess whether an over-dispersion adjustment was used or needed.
Overall, the listed design supports identifying the randomized comparison and endpoint, but the statistical methods used to analyze the primary outcome are not reported in the registry record. The methods discussion above distinguishes general concepts from trial-specific information; it should not be taken as a description of an undocumented analysis plan.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists seven outcome measures and ten analyses, but it does not report how the analyses were organized, which were designated primary or secondary in the analysis plan, or whether any multiplicity adjustment was planned. When a study examines multiple outcomes or performs multiple comparisons, the chance of at least one apparently unusual result can increase. General approaches to addressing this include prespecifying a hierarchy of outcomes or adjusting inference across tests. The registry record does not say whether either approach was used, so no conclusion about multiplicity control is possible.
The primary outcome is identified as infection rates at 30 days. The registry record does not provide its results or say whether all randomized participants were included in the analysis. It also does not report how missing endpoint data were handled, whether participants were analyzed according to their assigned group, or how protocol deviations were treated. These details matter because exclusions or missing observations can affect the comparability created by randomization.
Information about the analysis populations, reasons for missing data, and outcome ascertainment is not reported in the registry record. It is also not reported whether an analysis plan was finalized before results were examined, or whether interim analyses were conducted. No assumptions about these matters can be made from the listed design. The ten analyses should not be treated as ten independent confirmations, nor do their number alone reveal the direction or reliability of any result.
General statistical context: missingness can be informative if the chance of an unavailable outcome is related to a participant’s health or outcome status. Different assumptions about missing outcomes can yield different estimates. Without counts of missing outcomes and a stated handling method, robustness to missing data cannot be evaluated. Likewise, without a reported multiplicity strategy, p-values across outcomes, if any, would need cautious interpretation.
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 |
|---|---|---|---|
| Strict Glycemic Control | 16 | 50 | 32.0% |
| Standard of Care Control | 11 | 50 | 22.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Strict Glycemic Control | 12 of 50 |
| Standard of Care Control | 9 of 50 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Strict Glycemic Control | 45 of 50 |
| Standard of Care Control | 42 of 50 |
Most frequent serious adverse event terms
| Event term | Organ system | Strict Glycemic Control | Standard of Care Control |
|---|---|---|---|
| Graft Loss | Hepatobiliary disorders | 16 of 50 | 11 of 50 |
| Death | Hepatobiliary disorders | 12 of 50 | 9 of 50 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Strict Glycemic Control | Standard of Care Control |
|---|---|---|---|
| Infections | Infections and infestations | 35 of 50 | 32 of 50 |
| Biliary Stricture | Hepatobiliary disorders | 13 of 50 | 20 of 50 |
| Bile Leak | Hepatobiliary disorders | 14 of 50 | 15 of 50 |
| Re-operation - other | Surgical and medical procedures | 15 of 50 | 9 of 50 |
| Wound dehiscence | Surgical and medical procedures | 12 of 50 | 5 of 50 |
| Re-operation for bleeding | Surgical and medical procedures | 10 of 50 | 6 of 50 |
| Dialysis - renal failure | Renal and urinary disorders | 6 of 50 | 9 of 50 |
| Major Cardiac Event | Cardiac disorders | 4 of 50 | 5 of 50 |
| Portal Vein Thrombosis | Vascular disorders | 3 of 50 | 3 of 50 |
Serious events with the highest arm-level rate: graft loss (32.0%), death (24.0%).
The registry lists safety figures for Strict Glycemic Control and Standard of Care Control separately. For serious adverse events, the listed at-risk and affected counts are 50 and 16 in the strict-control group, and 50 and 11 in the standard-care group. For other adverse events, the corresponding entries are 50 and 45, and 50 and 42. The recorded death counts are 12 for Strict Glycemic Control and 9 for Standard of Care Control.
The registry also lists Graft Loss at 32.0% and Death at 24.0% among its top serious terms. The record does not clarify whether these term percentages are pooled across groups, how the denominator was defined, or whether they refer to participants or event reports. They should therefore be read as entries in the registry’s serious-event listing, not as a direct arm-to-arm comparison.
General safety-reporting context: affected-participant counts and event-term percentages can describe different levels of information. A participant may experience more than one event, and a single event may be represented in a category and a term listing. The record does not explain overlap or provide a statistical comparison of the safety figures. The counts alone do not establish whether an event was caused by the intervention. The timeframe and analysis population for these safety entries are also not reported in the registry record, so the death counts should not be interpreted as the 1-year survival endpoint.
12. What the Result Does, and Does Not, Mean
The registry record documents a randomized comparison of strict intraoperative glycemic control with standard insulin dosing during liver transplantation. It defines the primary endpoint as participants who sustained an infection after surgery within 30 days. These details establish the research question and the endpoint’s basic meaning.
The record does not report numerical primary infection results by group, an estimated treatment contrast, or uncertainty around that contrast. It therefore does not show whether infection counts were higher or lower under either strategy, how large a difference might have been, or how precisely that difference was estimated. No claim that strict control improved or worsened the primary outcome can be drawn from the available information.
The stated objective also mentions 1-year recipient survival and surgical complications. Those objectives should not be mistaken for evidence that the corresponding outcomes favored either arm. The registry lists secondary outcomes, but numerical results for those outcomes are not reported in the registry record for this analysis. Similarly, the safety counts describe recorded events but do not establish causal attribution or replace an analysis of a prespecified endpoint.
General statistical context: statistical significance and clinical importance are distinct. A small estimated difference can be statistically detectable when uncertainty is low, while an important difference can remain uncertain when data are limited. Interpreting either requires the estimate, its uncertainty, outcome definitions, and the context of the study. Those primary-outcome details are not reported in the registry record. The trial’s completed status means the study is recorded as completed; it does not by itself supply the results or determine what the evidence means.
The appropriate conclusion is limited: the record describes the comparison and endpoint but does not provide the primary result needed to judge the observed infection contrast. The findings should not be inferred from planning illustrations, safety counts, or the stated objectives.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of why a clear design description and a numerical outcome report serve different purposes. The registry specifies randomization, a parallel-group comparison, the two insulin strategies, and an infection endpoint at 30 days. That is enough to identify the question the investigators set out to address, but not enough to quantify the result.
For a binary endpoint, counts by group and an effect estimate with uncertainty are central to interpretation. Without them, readers cannot distinguish a small contrast from a large one, or a precise estimate from an uncertain one. A trial’s completed status, enrollment entry, and stated objectives do not fill this gap. Nor can safety entries be substituted for efficacy results, because they address different recorded outcomes and may use different definitions or follow-up.
The trial also illustrates the importance of separating study planning from study findings. Sample-size illustrations based on assumptions can inform prospective design choices, but they are not observed power and do not reveal whether the trial’s primary result was persuasive. The registry’s description explicitly characterizes the illustration as separate from the trial’s own design. Without numerical planning outputs or the underlying analysis details, those calculations do not add an outcome conclusion.
Finally, interpretation depends on transparency about analysis populations, missing data, endpoint definitions, and multiplicity. These are not reported in the registry record. Their absence does not prove that the trial was conducted improperly; it limits what can be independently assessed from this record. Statistically, the key lesson is to distinguish a well-defined comparison from a fully reported estimate of that comparison. Here, the former is described, while the numerical primary-outcome evidence is not.
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.
Several trial-specific limitations in interpretation arise from details not reported in the registry record. The infection endpoint is described as participants who sustained an infection after surgery, but the record does not define qualifying infections, indicate how they were confirmed, or describe whether outcome assessment was standardized. These details affect how consistently an event may have been identified and how well the endpoint can be reproduced.
The record does not provide primary infection counts by arm, an effect estimate, or uncertainty measures. It also does not provide numerical results for the stated 1-year survival objective or the listed secondary outcomes. The absence of these results prevents assessment of the direction, magnitude, and precision of the outcome comparisons.
Although allocation is described as randomized and masking as none, the method of sequence generation and allocation concealment are not reported. The record does not provide baseline characteristics, so group comparability cannot be assessed. It also does not specify whether outcome assessors were masked. These omissions limit assessment of potential selection and measurement concerns without establishing that such problems occurred.
Further, the analysis populations, missing-data counts and methods, handling of protocol deviations, and statistical analysis plan are not reported. The record does not describe multiplicity control across the listed outcomes and analyses, or indicate whether interim analyses were conducted. Safety-event definitions, timeframes, possible overlap between categories, and denominators for the listed term percentages are also unclear. Each of these limits restricts interpretation of the registry entries; none should be filled by assumption.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Intraoperative Glucose Control in Liver Transplant — NCT00780026.
- Registry record last updated 2019-01-15; status last verified 2018-12.
- Results first posted 2017-12-06.
- 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 NCT00780026, Intraoperative Glucose Control in Liver Transplant, as a completed randomized, prospective, parallel-group PHASE4 trial with no masking. Enrollment is listed as 100. The recorded start is 2008-07, primary completion is 2009-09, and the sponsor is University of Michigan.
The comparison is strict intraoperative glycemic control with insulin at 80 to 110 mg/dl versus standard of care insulin dosing. The primary endpoint is the number of participants with an infection after surgery at 30 days. The broader stated objective includes recipient survival at 1 year and postoperative complications.
Numerical primary infection results, effect estimates, uncertainty measures, and detailed analysis methods are not reported in the registry record available for this analysis. The record lists safety counts and selected serious-event terms, but their denominators, timeframe, and relationship to the primary endpoint are not fully described. The registry therefore documents the question and design but does not provide enough primary-outcome information to determine the observed infection comparison.