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

Critical Illness Clinical Trial

— SMART-SURG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02547779
• Other study ID #: IRB# 141349
• Status: Completed
• Phase: N/A
• Start date: October 1, 2015
• Est. completion date: June 30, 2017

Study information

• Verified date: November 2019
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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-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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10421
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Admitted to a participating non-medical intensive care unit (ICU) at Vanderbilt University Medical Center

Exclusion Criteria:

• Age<18 years old

Related Conditions & MeSH terms

• Acute Kidney Injury
• Critical Illness

Intervention

Other:
• 0.9% Saline
0.9% Saline will be used whenever an isotonic crystalloid is ordered
• Physiologically-balanced isotonic crystalloid
Lactated Ringers or Plasma-Lyte© A will be used whenever an isotonic crystalloid is ordered

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Kidney Event Within 30 Days	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 days after enrollment censored at hospital discharge
Secondary	30-day In-hospital Mortality	Death before hospital discharge, censored at 30 days after enrollment	30 days after enrollment censored at hospital discharge