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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
Sponsor:
Information provided by (Responsible Party):
Todd Rice, Vanderbilt University

Brief Summary:
The administration of intravenous fluids is ubiquitous in the care of the critically ill. Commonly available isotonic crystalloid solutions contain a broad spectrum electrolyte compositions including a range chloride concentrations. Recent studies have associated solutions with supraphysiologic chloride content with hyperchloremia, metabolic acidosis and renal vasoconstriction, acute kidney injury and renal replacement therapy, and increased mortality but no large, randomized-controlled trials have been conducted. SMART-MED will be a large, cluster-randomized, multiple-crossover trial enrolling critically ill patients from the Medical ICU at Vanderbilt University from June 2015 until April 2017. The primary endpoint will be the incidence of Major Adverse Kidney Events in 30 days after enrollment (MAKE30 is the composite of death, new renal replacement, or persistent renal dysfunction at discharge).

Condition or disease Intervention/treatment Phase
Critical Illness Acute Kidney Injury Other: 0.9% Saline Other: Physiologically-balanced isotonic crystalloid Not Applicable

Detailed Description:
SMART-MED is a large, cluster-randomized, multiple-crossover trial of 0.9% saline versus physiologically-balanced isotonic crystalloids (Lactated Ringers or Plasma-Lyte© A) with regard to the incidence of major adverse kidney events by 30 days in patients admitted to the medical intensive care unit. Between June 2015 and April 2017, all patients admitted to the medical intensive care unit at Vanderbilt University medical center who are 18 years or older will be enrolled. The study will occur in one-month blocks. The ICU will be randomized to an initial fluid group (0.9% saline or physiologically balanced crystalloids). The assigned fluid will be used exclusively for all patients receiving isotonic crystalloid for the duration of the month-long block (except in the presence of pre-specified contraindications). The assigned study fluid will switch at the end of each month-long block such that half of the months are assigned to 0.9% saline and half of the months are assigned to physiologically balance fluid. It is anticipated that around 5,300 patients will be enrolled from the medical ICU during the study period. All aspects of study design, intervention, and data collection will be harmonized with an independent study addressing the same question in the non-medical intensive care units at Vanderbilt University during a similar study period (SMART-SURG). A pre-specified data analysis plan will dictate the harmonized analysis of SMART-MED and SMART-SURG.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5381 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Other Names:
  • Normal Saline
  • 0.9% sodium chloride

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
Other Names:
  • Lactated Ringers
  • Ringer's Lactate
  • Plasma-Lyte© A




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Admitted to the medical intensive care unit (ICU) at Vanderbilt University Medical Center

Exclusion Criteria:

  • Age<18 years old

Information from the National Library of Medicine

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


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37209
Sponsors and Collaborators
Vanderbilt University
Investigators
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Principal Investigator: Todd W Rice, M.D. Vanderbilt University
  Study Documents (Full-Text)

Documents provided by Todd Rice, Vanderbilt University:

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Todd Rice, Associate Professor of Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02444988     History of Changes
Other Study ID Numbers: IRB#141349
First Posted: May 15, 2015    Key Record Dates
Results First Posted: November 25, 2019
Last Update Posted: November 25, 2019
Last Verified: November 2019
Keywords provided by Todd Rice, Vanderbilt University:
crystalloid
acute kidney injury
Additional relevant MeSH terms:
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Acute Kidney Injury
Critical Illness
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes
Plasma-lyte 148
Ophthalmic Solutions
Pharmaceutical Solutions