NCT02547779: SMART-SURG

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

Completed NA Results posted Last updated 25 November 2019

What this trial tests

NA trial testing 0.9% Saline in Critical Illness in 10,421 participants. Completed in 30 June 2017.

Timeline

1 October 2015

Primary endpoint
30 June 2017

30 June 2017

Quick facts

Lead sponsor	Vanderbilt University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	10,421
Start date	1 October 2015
Primary completion	30 June 2017
Estimated completion	30 June 2017
Sites	1 location across United States

Drugs / interventions tested

• 0.9% Saline
• Physiologically-balanced isotonic crystalloid

Conditions studied

• Critical Illness — all drugs for Critical Illness →
• Acute Kidney Injury — all drugs for Acute Kidney Injury →

Sponsor

Vanderbilt University

Who can join

18 and older, any sex, with Critical Illness or Acute Kidney Injury. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Major Adverse Kidney Event Within 30 Days Primary · 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.

Group	Value	95% CI
0.9% Sodium Chloride	551
Balanced Crystalloids	524

30-day In-hospital Mortality Secondary · 30 days after enrollment censored at hospital discharge

Death before hospital discharge, censored at 30 days after enrollment

Group	Value	95% CI
0.9% Sodium Chloride	408
Balanced Crystalloids	400

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

0.9% Sodium Chloride

Serious: 0/5214 (0%)

Deaths: 408/5214

Balanced Crystalloids

Serious: 0/5207 (0%)

Deaths: 400/5207

Other adverse events (1 terms — click to expand)

Reaction	System	0.9% Sodium Chloride	Balanced Crystalloids
Adverse Event	Renal and urinary disorders	—	—

Data from ClinicalTrials.gov NCT02547779 adverse events section.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Balanced Crystalloids versus Saline in Critically Ill Adults.
   Semler MW, Self WH, Wanderer JP, Ehrenfeld JM, et al · · 2018 · cited 868× · PMID 29485925 · DOI 10.1056/nejmoa1711584
2. Balanced Crystalloids versus Saline in Critically Ill Adults.
   Semler MW, Self WH, Rice TW. · · 2018 · cited 39× · PMID 29768150 · DOI 10.1056/nejmc1804294
3. Buffered solutions versus 0.9% saline for resuscitation in critically ill adults and children.
   Antequera Martín AM, Barea Mendoza JA, Muriel A, Sáez I, et al · · 2019 · cited 28× · PMID 31334842 · DOI 10.1002/14651858.cd012247.pub2
4. Balanced crystalloids versus saline in the intensive care unit: study protocol for a cluster-randomized, multiple-crossover trial.
   Semler MW, Self WH, Wang L, Byrne DW, et al · · 2017 · cited 23× · PMID 28302179 · DOI 10.1186/s13063-017-1871-1
5. Balanced Crystalloid versus Saline in Adults with Traumatic Brain Injury: Secondary Analysis of a Clinical Trial.
   Lombardo S, Smith MC, Semler MW, Wang L, et al · · 2022 · cited 22× · PMID 35443809 · DOI 10.1089/neu.2021.0465
6. Saline versus Balanced Crystalloids for Adults with Aneurysmal Subarachnoid Hemorrhage: A Subgroup Analysis of the SMART Trial.
   Mistry AM, Magarik JA, Feldman MJ, Wang L, et al · · 2022 · cited 11× · PMID 36186896 · DOI 10.1161/svin.121.000128
7. Reply to Gueret <i>et al.</i> and to Hammond <i>et al.</i>
   Brown RM, Wang L, Casey JD, Jackson KE, et al · · 2020 · cited 1× · PMID 31972099 · DOI 10.1164/rccm.202001-0073le
8. Effect of Balanced Crystalloids versus Saline on Urinary Biomarkers of Acute Kidney Injury in Critically Ill Adults
   Funke B, Jackson K, Self W, Collins S, et al · · 2020 · DOI 10.21203/rs.3.rs-44278/v1