Comparison · NCT02444988-4fa760c5
0.9% Sodium Chloride (Saline) vs Balanced Crystalloid: Major Adverse Kidney Event Within 30 Days
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. 0.9% Sodium Chloride (Saline) vs Balanced Crystalloid: Major Adverse Kidney Event Within 30 Days. Trial comparisons, record NCT02444988-4fa760c5. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02444988-4fa760c5
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.249 | 0.233 | 0.266 | wilson | |
| Risk in group 2 | 0.225 | 0.21 | 0.241 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0242 | 0.00147 | 0.0469 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.11 | 1.01 | 1.22 | log | |
| Odds ratio, group 1 over group 2 | 1.14 | 1.01 | 1.3 | log | |
| Number needed to treat, for one more participant with the outcome on 0.9% Sodium Chloride (Saline) than on Balanced Crystalloid | 41.3 | 21.3 | 680 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 0.9% Sodium Chloride (Saline) | Patients in an ICU block randomized to saline will receive 0.9% sodium chloride whenever isotonic intravenous fluid administration is ordered by the treating provider.~Saline: 0.9% sodium chloride will be used whenever an isotonic crystalloid is ordered | 659 | 2,646 | OG000 |
| Group 2 | Balanced Crystalloid | Patients in an ICU block randomized to balanced crystalloid will receive Plasma-Lyte A or Lactated Ringer's whenever isotonic intravenous crystalloid administration is ordered by the treating provider.~Balanced crystalloid: Lactated Ringers or Plasma-Lyte A will be used whenever an isotonic crystalloid is ordered | 615 | 2,735 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Major Adverse Kidney Event Within 30 Days
- Description
The primary outcome was the proportion of patients who met one or more criteria for a major adverse kidney event within 30 days - the composite of death, new receipt of renal-replacement therapy, or persistent renal dysfunction (defined as a final inpatient creatinine value ≥200% of the baseline value) - all censored at hospital discharge or 30 days after enrollment, whichever came first.
- Time frame
- 30 days after enrollment censored at hospital discharge
- Population
- Of the 15,802 patient enrolled in the SMART trial, 5381 were admitted to the medical ICU, 2646 in the saline group and 2735 in the balanced crystalloid group.
Source ClinicalTrials.gov
Trial
- Title
- Isotonic Solutions and Major Adverse Renal Events Trial in the Medical Intensive Care Unit
- NCT number
- NCT02444988
- Phases
- NA
- Conditions
- Critical Illness, Acute Kidney Injury
- Interventions
- 0.9% Saline, Physiologically-balanced isotonic crystalloid
- Lead sponsor
- Vanderbilt University
- Results first posted
- 2019-11-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02444988?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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