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01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Trials 1/2017

Balanced crystalloids versus saline in the intensive care unit: study protocol for a cluster-randomized, multiple-crossover trial

Zeitschrift:
Trials > Ausgabe 1/2017
Autoren:
Matthew W. Semler, Wesley H. Self, Li Wang, Daniel W. Byrne, Jonathan P. Wanderer, Jesse M. Ehrenfeld, Joanna L. Stollings, Avinash B. Kumar, Antonio Hernandez, Oscar D. Guillamondegui, Addison K. May, Edward D. Siew, Andrew D. Shaw, Gordon R. Bernard, Todd W. Rice, for the Isotonic Solutions and Major Adverse Renal Events Trial (SMART) Investigators, the Pragmatic Critical Care Research Group
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s13063-017-1871-1) contains supplementary material, which is available to authorized users.

Abstract

Background

Saline, the intravenous fluid most commonly administered to critically ill adults, contains a high chloride content, which may be associated with acute kidney injury and death. Whether using balanced crystalloids rather than saline decreases the risk of acute kidney injury and death among critically ill adults remains unknown.

Methods

The Isotonic Solutions and Major Adverse Renal Events Trial (SMART) is a pragmatic, cluster-level allocation, cluster-level crossover trial being conducted between 1 June 2015 and 30 April 2017 in five intensive care units at Vanderbilt University Medical Center in Nashville, TN, USA. SMART compares saline (0.9% sodium chloride) with balanced crystalloids (clinician’s choice of lactated Ringer’s solution or Plasma-Lyte A®). Each intensive care unit is assigned to provide either saline or balanced crystalloids each month, with the assigned crystalloid alternating monthly over the course of the trial. All adults admitted to participating intensive care units during the study period are enrolled and followed until hospital discharge or 30 days after enrollment. The anticipated enrollment is approximately 14,000 patients. The primary outcome is Major Adverse Kidney Events within 30 days—the composite of in-hospital death, receipt of new renal replacement therapy, or persistent renal dysfunction (discharge creatinine ≥200% of baseline creatinine). Secondary clinical outcomes include in-hospital mortality, intensive care unit-free days, ventilator-free days, vasopressor-free days, and renal replacement therapy-free days. Secondary renal outcomes include new renal replacement therapy receipt, persistent renal dysfunction, and incidence of stage 2 or higher acute kidney injury.

Discussion

This ongoing pragmatic trial will provide the largest and most comprehensive comparison to date of clinical outcomes with saline versus balanced crystalloids among critically ill adults.

Trial registration

For logistical reasons, SMART was prospectively registered separately for the medical ICU (SMART-MED; ClinicalTrials.gov identifier: NCT02444988; registered on 11 May 2015; date of first patient enrollment: 1 June 2015) and the nonmedical ICUs (SMART-SURG; ClinicalTrials.gov identifier: NCT02547779; registered on 9 September 2015; date of first patient enrollment: 1 October 2015).
Zusatzmaterial
Additional file 1: SPIRIT 2013 checklist: recommended items to address in a clinical trial protocol and related documents. (DOC 122 kb)
13063_2017_1871_MOESM1_ESM.doc
Additional file 2: This file contains supplemental tables and methods, including additional details regarding electronic health record-based data collection, power calculation, development of the model for the primary analysis, interim analyses, and handling of missing data for baseline creatinine. (DOCX 88 kb)
13063_2017_1871_MOESM2_ESM.docx
Additional file 3: This file contains a .pdf version of the R code that will be used to analyze the final study data. (PDF 118 kb)
13063_2017_1871_MOESM3_ESM.pdf
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