Isotonic Solutions and Major Adverse Renal Events Trial in the Medical Intensive Care Unit (SMART-MED)
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|ClinicalTrials.gov Identifier: NCT02444988|
Recruitment Status : Completed
First Posted : May 15, 2015
Results First Posted : November 25, 2019
Last Update Posted : November 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Critical Illness Acute Kidney Injury||Other: 0.9% Saline Other: Physiologically-balanced isotonic crystalloid||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5381 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Isotonic Solutions and Major Adverse Renal Events Trial in the Medical Intensive Care Unit|
|Actual Study Start Date :||June 1, 2015|
|Actual Primary Completion Date :||June 30, 2017|
|Actual Study Completion Date :||June 30, 2017|
Active Comparator: 0.9% Saline
Patients in an ICU block randomized to physiologically-balanced isotonic fluid will receive 0.9% Saline whenever isotonic intravenous fluid administration is ordered by the treating provider.
Other: 0.9% Saline
0.9% Saline will be used whenever an isotonic crystalloid is ordered
Active Comparator: Physiologically-balanced
Patients in an ICU block randomized to physiologically-balanced isotonic fluid will receive Plasma-Lyte© A or Lactated Ringer's whenever isotonic intravenous fluid administration is ordered by the treating provider.
Other: Physiologically-balanced isotonic crystalloid
Lactated Ringers or Plasma-Lyte© A will be used whenever an isotonic crystalloid is ordered
- Major Adverse Kidney Event Within 30 Days [ Time Frame: 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.
- 30-day In-hospital Mortality [ Time Frame: 30 days after enrollment censored at hospital discharge ]Death before hospital discharge, censored at 30 days after enrollment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02444988
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37209|
|Principal Investigator:||Todd W Rice, M.D.||Vanderbilt University|