Trial · NCT02444988
Isotonic Solutions and Major Adverse Renal Events Trial in the Medical Intensive Care Unit
NCT02444988, Not applicable, Completed, Vanderbilt University; results first posted 2019-11-25
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Isotonic Solutions and Major Adverse Renal Events Trial in the Medical Intensive Care Unit. Trials, record NCT02444988. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02444988
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Isotonic Solutions and Major Adverse Renal Events Trial in the Medical Intensive Care Unit
- NCT number
- NCT02444988
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 5,381 participants, actual
- Lead sponsor
- Vanderbilt University
- Conditions
- Critical Illness, Acute Kidney Injury
- Interventions
- 0.9% Saline, Physiologically-balanced isotonic crystalloid
- First posted
- 2015-05-15
- Last updated
- 2019-12-16
- Results first posted
- 2019-11-25
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Major Adverse Kidney Event Within 30 Days | 30 days after enrollment censored at hospital discharge | 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. |
| Secondary | 30-day In-hospital Mortality | 30 days after enrollment censored at hospital discharge | Death before hospital discharge, censored at 30 days after enrollment |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Major Adverse Kidney Event Within 30 Days | 30 days after enrollment censored at hospital discharge | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 30-day In-hospital Mortality | 30 days after enrollment censored at hospital discharge | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Major Adverse Kidney Event Within 30 Days | 0.9% Sodium Chloride (Saline) | 659 | Participants | ||
| Major Adverse Kidney Event Within 30 Days | Balanced Crystalloid | 615 | Participants | ||
| 30-day In-hospital Mortality | 0.9% Sodium Chloride (Saline) | 467 | Participants | ||
| 30-day In-hospital Mortality | Balanced Crystalloid | 418 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 0.9% Sodium Chloride (Saline) | 2,646 | |
| Overall Study | STARTED | Balanced Crystalloid | 2,735 | |
| Overall Study | COMPLETED | 0.9% Sodium Chloride (Saline) | 2,646 | |
| Overall Study | COMPLETED | Balanced Crystalloid | 2,735 | |
| Overall Study | NOT COMPLETED | 0.9% Sodium Chloride (Saline) | 0 | |
| Overall Study | NOT COMPLETED | Balanced Crystalloid | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 0.9% Sodium Chloride (Saline) | 467 | 2,646 |
| Total, all-cause mortality | Balanced Crystalloid | 418 | 2,735 |
| Total, other adverse events | 0.9% Sodium Chloride (Saline) | 0 | 2,646 |
| Total, other adverse events | Balanced Crystalloid | 0 | 2,735 |
| Total, serious adverse events | 0.9% Sodium Chloride (Saline) | 0 | 2,646 |
| Total, serious adverse events | Balanced Crystalloid | 0 | 2,735 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 0.9% Sodium Chloride (Saline) vs Balanced Crystalloid: Major Adverse Kidney Event Within 30 Days | Trial comparisons |
| 0.9% Sodium Chloride (Saline) vs Balanced Crystalloid: deaths from any cause | Trial comparisons |
| 0.9% Sodium Chloride (Saline) vs Balanced Crystalloid: 30-day In-hospital Mortality | Trial comparisons |
| 0.9% Sodium Chloride (Saline) vs Balanced Crystalloid: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02444988
GET https://conductscience.org/api/trials/v1/NCT02444988/registered