Examination of the Effects of Chromium Levels on Glucose Metabolism, Lipid Metabolism, Morbidity and Mortality Rates in Patients Followed in Intensive Care Unit: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Examination of the Effects of Chromium Levels on Glucose Metabolism, Lipid Metabolism, Morbidity and Mortality Rates in Patients Followed in Intensive Care Unit (NCT06334042), a registered phase not stated study. The primary outcome is Serum Chromium Level.

2. Clinical Question

The study asks whether serum chromium levels in critically ill intensive care patients are associated with glucose metabolism, lipid metabolism, morbidity and mortality. It describes repeated chromium measurements during an ICU stay, beginning at admission, alongside clinical measures including blood glucose, HbA1c, lipid profile and glycemic variability. The registry record does not report results that quantify these relationships, so their direction and strength cannot be assessed from the record.

3. Trial Design

This is an observational study of intensive care patients, not a randomized treatment comparison. The registry lists one group, Intensive Care Patients, and identifies serum chromium level as a diagnostic test. No allocation to different treatments or control conditions is described. Accordingly, the design as recorded can describe measured levels and their patterns, but does not by itself establish effects caused by changing chromium levels.

The record states that 309 participants were included. Serum chromium was measured weekly during the ICU stay, beginning at admission. The primary outcome timeframe specifies day 0, day 7, day 14 and day 21. The record gives 309 participants at the first measurement and 51 participants who completed the seventh day at the second measurement. The available description of the third measurement is incomplete, and the record does not report the corresponding count for later time points.

The study summary describes collection of a blood sample on the day of ICU admission and repeat sampling once a week during the stay, alongside routine blood tests. The record does not provide more detail on how the measurement schedule was handled when a participant left the ICU before a later measurement.

The study is marked completed, with a start date of 2024-02-07 and a primary completion date of 2024-08-08. These status and date fields describe the study record; they do not supply outcome findings. The record does not report a protocol, a sample-size justification, an interim analysis plan, or the statistical analysis plan. No participant-level or group-level outcome estimates are reported.

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: All of the enrolled participants were included in the study.

Overall Study

Analysis population for the primary outcome, as defined in the registry: A total of 309 participants were included in the study. Measurements were taken once a week throughout their hospital stay. In the first measurement (ICU admission/day 0), 309 participants; in the second measurement (participants who completed the 7th day of ICU stay), 51 participants; in the third measurement (participants who completed the 14th day of ICU stay), 24 participants; and in the fourth measurement (participants who completed the 21st day of ICU stay), 13 participants were assessed.

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.

6. Primary Endpoint

The registry lists the primary outcome as Serum Chromium Level, measured over Once a week throughout the participant's ICU stay, starting from admission (day 0, day 7, day 14 and day 21)..

The primary endpoint is serum chromium level, measured in µg/L and described using a mean and standard deviation. The registry specifies repeated measurements beginning at ICU admission and continuing weekly during the ICU stay, with time points listed as day 0, day 7, day 14 and day 21. It also states that a healthy reference range of 0.7 to 28.0 µg/L was used for blood chromium levels.

Chromium is the measurement central to the study’s stated question about glucose metabolism, lipid metabolism, morbidity and mortality. Repeated measurement can describe how observed serum levels vary over a patient’s ICU stay. The mean summarizes the central level for a set of measurements, while the standard deviation describes their spread around that mean. These are general statistical interpretations of the chosen summaries; the record does not report the actual means or standard deviations at the listed time points.

The reference range is context for interpreting chromium measurements, not a randomized comparator or evidence that participants inside or outside the range had different clinical outcomes. The registry record does not report the distribution of values relative to that range, estimates linking chromium to clinical outcomes, or uncertainty intervals for the primary endpoint.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registered primary outcome is a continuous measurement: serum chromium level in µg/L. The record specifies the mean and standard deviation as the summary statistics. In general, the mean describes the central level of a set of observations. The standard deviation describes how dispersed individual observations are around that mean. Neither summary alone shows the full distribution, and neither establishes a relationship with a clinical outcome. The registry record does not report numerical values for either summary.

What do repeated measurements contribute?

Measurements at admission and at weekly time points can describe chromium levels over the course of an ICU stay. In general, repeated observations can help distinguish a pattern over time from a single measurement. Interpretation depends on knowing who contributed data at each time point and how repeated observations were analyzed. The record lists day 0, day 7, day 14 and day 21, but only gives participant counts for the first and second measurements. The available description for the third measurement is incomplete. It does not report a method for analyzing within-participant change or for handling measurements that are not available at later time points.

The participant counts at different time points should not be treated as evidence of why data are absent. In general, later measurements may be unavailable for several reasons, and those reasons can affect the meaning of a time trend. The registry record does not report the reasons for the counts or an analysis accounting for them. The mean at one time point, if available, would describe the participants measured at that time unless the analysis specified another approach; the record does not give enough detail to determine the analysis population.

How should an association be interpreted?

In general, an observational study measures exposures or biomarkers without randomly assigning them. An association between serum chromium and blood glucose, HbA1c, lipid profile, glycemic variability, morbidity or mortality would therefore not alone show that chromium caused a change in the other measure. Other patient characteristics or clinical circumstances could be related to both. Adjusted analyses can sometimes address measured factors, but the registry record does not report an adjustment strategy, covariates, model form or estimated associations.

For continuous outcomes, analysts may use statistical models to estimate relationships between measurements, but the appropriate model depends on the research question, the data structure and the distribution of the measures. Repeated observations from the same participant are generally not independent; methods that account for that dependence may be relevant. This is general guidance, not a description of an analysis reported for this study. The registry record lists zero analyses and does not state what model, if any, was used.

What would a confidence interval tell a reader?

In general, a confidence interval expresses statistical uncertainty around an estimated quantity under the assumptions of the method used. A narrower interval indicates greater precision for that estimate, while a wider interval indicates less precision. An interval does not by itself rule out bias, confounding, measurement problems or other limitations. No confidence intervals or numerical effect estimates are reported in the registry record, so the precision of the study’s outcome findings cannot be assessed.

A p-value, in general, describes how compatible data are with a specified statistical model and null hypothesis. It does not measure the size or clinical importance of an association. The registry record does not report p-values or hypotheses tested. No conclusion about statistical significance can therefore be drawn from the listed study details.

What do the planning assumptions mean?

The record describes a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation. For non-time-to-event outcomes, the stated convention is participants per arm; time-to-event planning is described in terms of total events. Such sample-size calculations are planning illustrations, not observed power and not evidence that the study was designed as a two-arm randomized trial. The actual study is described as observational and lists one group. The record does not report the effect used for the illustration or numerical planning results, and does not identify these assumptions as the study’s own design justification.

General principles such as checking distributions, accounting for repeated measures and assessing missingness can help readers understand what a complete statistical report might address. They are not evidence that these procedures were used in this study. The registry record does not report analytic methods in enough detail to evaluate model assumptions, multiplicity handling or robustness of estimates.

10. Multiplicity, Missing Data and Analysis Populations

The record lists a primary outcome of serum chromium level and four secondary outcomes: HbA1c, blood glucose, lipid profile and glycemic variability measured by coefficient of variation. It also describes interest in morbidity and mortality in the study summary, but the record does not report numerical results for those topics. When several outcomes or comparisons are examined, the chance of at least one apparently notable result can increase. In general, a prespecified testing strategy or multiplicity adjustment can help clarify how such results should be interpreted. The registry record does not report whether either was used.

The registry record does not report a statistical analysis plan, the number of tests performed, or how any repeated measurements were handled analytically. It also does not report whether outcomes or analyses were selected after the data were examined. With no analyses reported, it is not possible to assess how multiplicity affected the findings.

For missing data, the record gives 309 participants at the first chromium measurement and 51 participants who completed the seventh day for the second measurement. The description of the third measurement is incomplete. The record does not explain the reasons for measurements being unavailable at different times, describe missingness by outcome, or state whether imputation or another missing-data method was used. In general, missing measurements can affect estimates if the participants observed at a time point differ systematically from those without measurements; the record does not provide information to assess this possibility.

The analysis populations are not described beyond the stated participant counts for the first two time points. The registry record does not report criteria for inclusion in each analysis or whether any participants were excluded from outcome analyses. These omissions limit assessment of both the representativeness of the reported measurements and the handling of repeated observations.

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

The study is relevant to questions about chromium levels and metabolic measures in intensive care, and the registry records repeated serum chromium measurement during participants’ ICU stays. The stated outcomes include glucose- and lipid-related measures, while the study summary also names morbidity and mortality. These details explain the research aim, but they are not findings about the relationship between chromium and those outcomes.

The registry record does not report numerical outcome results or analyses. It therefore does not show whether chromium levels were higher or lower at any time point, whether they changed during the ICU stay, or whether they were associated with HbA1c, blood glucose, lipid profile, glycemic variability, morbidity or mortality. It also does not report estimates or uncertainty intervals that would indicate the precision of any relationship.

Even if an association were reported, an observational design would not establish that chromium caused an outcome to change. In general, associations can reflect other characteristics or circumstances, and their interpretation depends on measurement quality, analysis methods and potential confounding. The registry record does not provide enough analytic detail to evaluate these issues for this study.

The healthy reference range of 0.7 to 28.0 µg/L is a stated reference for blood chromium levels. It is not evidence that a particular level predicts a clinical outcome, and the registry record does not report how the cohort’s measurements compared with that range. Likewise, the fact that the study is marked completed does not substitute for posted results.

The record supports a description of the cohort, measurement schedule and research question. It does not support conclusions about treatment, clinical benefit, harm or the value of changing chromium levels. Those conclusions would require outcome findings and methods that are not reported in the registry record.

12. Why This Trial Matters Statistically

This study illustrates the distinction between a biological measurement and a clinical outcome. Serum chromium is the registered primary measure, while glucose and lipid measures are listed as secondary outcomes and morbidity and mortality appear in the study’s stated aims. Keeping these roles distinct matters: a measured biomarker does not automatically establish a change in health outcomes, and an association between measures would not by itself establish causation.

The repeated measurement schedule also raises a central statistical issue. The record gives 309 participants at admission and 51 participants who completed day 7, while later measurement details are incomplete. A summary at each time point can describe the people measured then, but interpretation over time depends on knowing how participant availability changed and how repeated data were analyzed. The record does not report those details.

Observational evidence can be useful for describing patterns and generating questions, but its interpretation depends on the possibility of confounding and on transparent reporting of methods. The registry record does not report numerical outcome results, uncertainty estimates or an analysis plan. This makes it impossible to judge the magnitude or precision of any relationship between chromium and the outcomes of interest.

Finally, planning illustrations should not be mistaken for study design evidence. The registry’s stated assumptions describe a hypothetical sample-size calculation, whereas the recorded study is observational and lists one patient group. That difference reinforces why design, analysis and interpretation need to be read together. In this record, the question and measurement schedule are described, but the results needed to assess the proposed relationships are not reported.

13. 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 outcome information in the registry record is incomplete for assessing the study’s stated aims. It identifies serum chromium as the primary measure and names HbA1c, blood glucose, lipid profile and glycemic variability as secondary outcomes, but reports no numerical results or analyses. Although the summary refers to morbidity and mortality, the record does not provide corresponding estimates or findings. The title’s reference to these outcomes should not be read as evidence that a relationship was observed.

The description of repeated measurements does not give participant counts for all listed time points. It reports 309 participants at the first measurement and 51 participants who completed the seventh day at the second measurement, but the description of the third measurement is truncated. Reasons for the different counts and the status of later measurements are not reported in the registry record. This limits evaluation of how well measurements at different times can be compared.

The registry record does not describe methods for handling repeated observations, missing data, confounding, multiplicity or analysis populations. It also does not report a protocol, statistical analysis plan, sample-size justification or interim analysis plan. Consequently, the methods used to produce any results cannot be evaluated from the record.

The study is observational and lists only Intensive Care Patients, with no randomized control group. The healthy chromium reference range is not a concurrent comparison group. These design details limit causal interpretation, even if outcome associations were available. The registry record does not report numerical results that would permit assessment of either associations or their precision.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: Examination of the Effects of Chromium Levels on Glucose Metabolism, Lipid Metabolism, Morbidity and Mortality Rates in Patients Followed in Intensive Care Unit — NCT06334042.
• Registry record last updated 2025-04-13; status last verified 2025-04.
• Results first posted 2025-04-13.
• 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.

17. Record Summary

The registry describes a completed observational study of serum chromium levels in intensive care patients. It states that 309 participants were included and that chromium measurement began at ICU admission, with weekly measurements during the ICU stay. The primary outcome is mean serum chromium level in µg/L, summarized with a standard deviation. The listed time points are day 0, day 7, day 14 and day 21.

Secondary outcomes are HbA1c, blood glucose, lipid profile and glycemic variability measured by coefficient of variation. The study summary also names morbidity and mortality as topics of interest. The record lists 309 participants at the first measurement and 51 participants completing the seventh day at the second measurement; the available third-measurement description is incomplete.

No numerical outcome results, analyses or statistical analysis plan are reported in the registry record. The record therefore describes the research question and measurement schedule, but does not establish the observed relationships between chromium and clinical outcomes.