This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record.
1. Trial at a Glance
ANDROMEDA-SHOCK was a randomized, parallel, single-masked clinical trial evaluating two approaches to fluid resuscitation guidance in septic shock.
| Feature | ANDROMEDA-SHOCK |
|---|---|
| NCT ID | NCT03762005 |
| Title | Peripheral Perfusion Versus Lactate Targeted Fluid Resuscitation in Septic Shock |
| Phase | NA |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Primary purpose | Treatment |
| Sponsor | Pontificia Universidad Catolica de Chile |
2. Clinical Question
Population
Patients with septic shock, hyperlactatemia, and peripheral perfusion considerations.
Intervention
CRT guided resuscitation.
Comparator
Lactate guided resuscitation.
Primary question
Does the selected resuscitation guidance strategy influence the amount of fluid administered during the initial protocol period?
3. Trial Design
Patients were assigned using a randomized design.
Parallel two-arm comparison.
Single masking.
Two resuscitation strategies.
4. Study Arms
CRT guided resuscitation
Intervention arm using peripheral perfusion guidance.
Lactate guided resuscitation
Comparator arm using lactate guidance.
5. Endpoints
| Endpoint | Time frame | Description |
|---|---|---|
| Amount of resuscitation fluids | At six hours | The total amount of fluids administered as fluid challenges from baseline to 6 hours after starting protocol. |
6. Statistical Methodology
The registry identifies the primary endpoint as a continuous measurement of fluid administration over a defined six-hour period. Statistical analysis of an endpoint of this type generally compares the distribution of fluid volumes between randomized groups using methods appropriate for the observed data characteristics.
The statistical interpretation depends on the prespecified analysis method, assumptions about distribution, variability, and handling of missing observations.
7. Planned Analysis
The registry reports measurement of the amount of resuscitation fluids administered as fluid challenges from baseline to six hours after starting protocol. No statistical analyses are posted to ClinicalTrials.gov for this endpoint.
For a randomized comparison of a continuous outcome, an analysis would typically estimate the difference between groups with uncertainty measures such as confidence intervals. The clinical interpretation would depend on the size and precision of that estimated difference rather than the endpoint alone.
8. Statistical Methods Explained
Why is randomization important in this trial?
Randomization creates the basis for comparing two resuscitation strategies because treatment assignment is determined independently of patient characteristics.
Why is the primary endpoint measured at six hours?
A fixed time window creates a standardized comparison of fluid administration during the early protocol period.
What type of statistical outcome is amount of fluid?
Fluid volume is a continuous outcome, meaning each participant contributes a numerical measurement rather than an event occurrence.
Why does masking matter?
Masking can reduce the influence of knowledge of assignment on trial conduct or assessment when applicable.
Why are confidence intervals useful?
Confidence intervals describe uncertainty around an estimated treatment difference and help distinguish precise from imprecise estimates.
Why does a p-value not describe clinical importance?
A p-value addresses compatibility with a statistical hypothesis. It does not directly describe the magnitude or practical importance of an observed difference.
9. Limitations
- The ClinicalTrials.gov record does not report posted statistical analyses for the primary endpoint.
- The registry does not report endpoint estimates, confidence intervals, or p-values.
- Detailed analysis populations and handling of missing data are not reported in the registry record.
- The interpretation of the primary endpoint depends on the prespecified statistical analysis plan.
10. Why This Trial Matters Statistically
ANDROMEDA-SHOCK illustrates several important principles in clinical trial methodology:
| Concept | Application |
|---|---|
| Randomization | Comparison of two prospectively assigned resuscitation strategies. |
| Parallel design | Two groups evaluated concurrently. |
| Continuous outcomes | Primary endpoint based on amount of fluid administered. |
| Time-defined endpoint | Measurement window defined as six hours. |
| Statistical uncertainty | Interpretation requires estimates and precision measures. |
11. Related Tutorials
Learn more about the methods used in this trial: