0.9% Sodium Chloride vs Balanced Crystalloids: Major Adverse Kidney Event Within 30 Days
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.106 | 0.0976 | 0.114 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.101 | 0.0928 | 0.109 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.00504 | -0.00664 | 0.0167 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.05 | 0.938 | 1.18 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.06 | 0.931 | 1.2 | log | ClinicalTrials.gov | |
| Number needed to treat, for one more participant with the outcome on 0.9% Sodium Chloride than on Balanced Crystalloids | 198 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
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 | Source |
|---|---|---|---|---|---|---|
| Group 1 | 0.9% Sodium Chloride | Patients in an ICU block randomized to saline will receive 0.9% sodium chloride whenever isotonic intravenous crystalloid administration is ordered by the treating provider.~Saline: 0.9% sodium chloride will be used whenever an isotonic crystalloid is ordered | 551 | 5,214 | OG000 | ClinicalTrials.gov |
| Group 2 | Balanced Crystalloids | Patients in an ICU block randomized to balanced crystalloids 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 | 524 | 5,207 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | Major Adverse Kidney Event Within 30 Days | ClinicalTrials.gov |
| 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. | ClinicalTrials.gov |
| Time frame | 30 days after enrollment censored at hospital discharge | ClinicalTrials.gov |
| Population | Of 15,802 patients in the SMART trial, 7,860 were assigned to saline and 7,942 were assigned to balanced crystalloids, of whom 10,421 were enrolled to surgical ICUs with 5,214 assigned to saline and 5,207 assigned to balanced crystalloids. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Isotonic Solutions and Major Adverse Renal Events Trial in the Non-Medical Intensive Care Unit (SMART-SURG) | ClinicalTrials.gov |
| NCT number | NCT02547779 | ClinicalTrials.gov |
| Phases | NA | ClinicalTrials.gov |
| Conditions | Critical Illness, Acute Kidney Injury | ClinicalTrials.gov |
| Interventions | 0.9% Saline, Physiologically-balanced isotonic crystalloid | ClinicalTrials.gov |
| Lead sponsor | Vanderbilt University | ClinicalTrials.gov |
| Results first posted | 2019-11-25 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT02547779?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.