Expired Study
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Nashville, Tennessee 37232


Purpose:

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-SURG will be a large, cluster-randomized, multiple-crossover trial enrolling critically ill patients from the non-medical ICUs at Vanderbilt University from October 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).


Study summary:

SMART-SURG 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 non-medical intensive care units. All patients admitted to participating non-medical intensive care units at Vanderbilt University medical center who are 18 years or older will be enrolled. The study will occur in one-month blocks. Each participating ICU will be randomized to an initial fluid group (0.9% saline or physiologically balanced isotonic 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 to physiologically balance fluid. The primary endpoint will be major adverse kidney events by 30 days (MAKE30 is the composite of death, new renal replacement therapy, or persistent renal dysfunction at discharge). All aspects of study design, intervention, and data collection will be harmonized with an ongoing, independent study addressing the same question in the medical intensive care unit at Vanderbilt University during a similar study period (SMART-MED). A pre-specified data analysis plan will dictate the harmonized analysis of SMART-MED and SMART-SURG.


Criteria:

Inclusion Criteria: - Admitted to a participating non-medical intensive care unit (ICU) at Vanderbilt University Medical Center Exclusion Criteria: - Age<18 years old


Study is Available At:


Original ID:

IRB# 141349


NCT ID:

NCT02547779


Secondary ID:


Study Acronym:

SMART-SURG


Brief Title:

Isotonic Solutions and Major Adverse Renal Events Trial in the Non-Medical Intensive Care Unit (SMART-SURG)


Official Title:

Isotonic Solutions and Major Adverse Renal Events Trial in Non-Medical Intensive Care Units


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Vanderbilt University Medical Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

10421


Enrollment Type:

Actual


Overall Contact Information

Official Name:Todd W Rice, MD, MSc
Principal Investigator
Vanderbilt University

Study Dates

Start Date:October 1, 2015
Completion Date:June 30, 2017
Completion Type:Actual
Primary Completion Date:June 30, 2017
Primary Completion Type:Actual
Verification Date:November 2019
Last Changed Date:November 5, 2019
First Received Date:September 9, 2015
First Results Date:August 19, 2019

Study Outcomes

Outcome Type:Secondary Outcome
Measure:30-day In-hospital Mortality
Time Frame:30 days after enrollment censored at hospital discharge
Safety Issues:False
Description:Death before hospital discharge, censored at 30 days after enrollment
Outcome Type:Primary Outcome
Measure:Major Adverse Kidney Event Within 30 Days
Time Frame:30 days after enrollment censored at hospital discharge
Safety Issues:False
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 inpatie

Study Interventions

Intervention Type:Other
Name:0.9% Saline
Description:0.9% Saline will be used whenever an isotonic crystalloid is ordered
Arm Name:0.9% Saline
Other Name:Normal Saline
Intervention Type:Other
Name:Physiologically-balanced isotonic crystalloid
Description:Lactated Ringers or Plasma-Lyte© A will be used whenever an isotonic crystalloid is ordered
Arm Name:Physiologically-balanced
Other Name:Lactated Ringers

Study Arms

Study Arm Type:Active Comparator
Arm Name:0.9% Saline
Description: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.
Study Arm Type:Active Comparator
Arm Name:Physiologically-balanced
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Vanderbilt University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Yunos NM, Bellomo R, Hegarty C, Story D, Ho L, Bailey M. Association between a chloride-liberal vs chloride-restrictive intravenous fluid administration strategy and kidney injury in critically ill adults. JAMA. 2012 Oct 17;308(15):1566-72. doi: 10.1001/jama.2012.13356.
PMID:23073953
Reference Type:Reference
Citation:Yunos NM, Kim IB, Bellomo R, Bailey M, Ho L, Story D, Gutteridge GA, Hart GK. The biochemical effects of restricting chloride-rich fluids in intensive care. Crit Care Med. 2011 Nov;39(11):2419-24. doi: 10.1097/CCM.0b013e31822571e5.
PMID:21705897
Reference Type:Reference
Citation:Finfer S, Liu B, Taylor C, Bellomo R, Billot L, Cook D, Du B, McArthur C, Myburgh J; SAFE TRIPS Investigators. Resuscitation fluid use in critically ill adults: an international cross-sectional study in 391 intensive care units. Crit Care. 2010;14(5):R185. doi: 10.1186/cc9293. Epub 2010 Oct 15.
PMID:20950434

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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