Trial Outcomes & Findings for Isotonic Solutions and Major Adverse Renal Events Trial in the Medical Intensive Care Unit (NCT NCT02444988)

Last Updated: 2019-12-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

5381 participants

Primary outcome timeframe

30 days after enrollment censored at hospital discharge

Results posted on

2019-12-16

Participant Flow

For randomization, we will generate two sequences of study group assignment (\[1\] saline during odd-numbered months and balanced crystalloid during even-numbered months; \[2\] balanced crystalloid during odd-numbered months and saline during even-numbered months). Participants will only receive 1 of the 2 interventions.

Participant milestones

Participant milestones
Measure	0.9% Sodium Chloride (Saline) Patients in an ICU block randomized to saline will receive 0.9% sodium chloride whenever isotonic intravenous fluid administration is ordered by the treating provider. Saline: 0.9% sodium chloride will be used whenever an isotonic crystalloid is ordered	Balanced Crystalloid Patients in an ICU block randomized to balanced crystalloid will receive Plasma-Lyte A or Lactated Ringer's whenever isotonic intravenous crystalloid administration is ordered by the treating provider. Balanced crystalloid: Lactated Ringers or Plasma-Lyte A will be used whenever an isotonic crystalloid is ordered
Overall Study STARTED	2646	2735
Overall Study COMPLETED	2646	2735
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Isotonic Solutions and Major Adverse Renal Events Trial in the Medical Intensive Care Unit

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0.9% Sodium Chloride (Saline) n=2646 Participants Patients in an ICU block randomized to saline will receive 0.9% sodium chloride whenever isotonic intravenous fluid administration is ordered by the treating provider. Saline: 0.9% sodium chloride will be used whenever an isotonic crystalloid is ordered	Balanced Crystalloid n=2735 Participants Patients in an ICU block randomized to balanced crystalloid will receive Plasma-Lyte A or Lactated Ringer's whenever isotonic intravenous crystalloid administration is ordered by the treating provider. Balanced crystalloid: Lactated Ringers or Plasma-Lyte A will be used whenever an isotonic crystalloid is ordered	Total n=5381 Participants Total of all reporting groups
Age, Continuous	56 years n=5 Participants	56 years n=7 Participants	56 years n=5 Participants
Sex: Female, Male Female	1251 Participants n=5 Participants	1294 Participants n=7 Participants	2545 Participants n=5 Participants
Sex: Female, Male Male	1395 Participants n=5 Participants	1441 Participants n=7 Participants	2836 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1978 Participants n=5 Participants	2032 Participants n=7 Participants	4010 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	668 Participants n=5 Participants	703 Participants n=7 Participants	1371 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days after enrollment censored at hospital discharge

Population: Of the 15,802 patient enrolled in the SMART trial, 5381 were admitted to the medical ICU, 2646 in the saline group and 2735 in the balanced crystalloid group.

Outcome measures

Outcome measures
Measure	0.9% Sodium Chloride (Saline) n=2646 Participants Patients in an ICU block randomized to saline will receive 0.9% sodium chloride whenever isotonic intravenous fluid administration is ordered by the treating provider. Saline: 0.9% sodium chloride will be used whenever an isotonic crystalloid is ordered	Balanced Crystalloid n=2735 Participants Patients in an ICU block randomized to balanced crystalloid will receive Plasma-Lyte A or Lactated Ringer's whenever isotonic intravenous crystalloid administration is ordered by the treating provider. Balanced crystalloid: Lactated Ringers or Plasma-Lyte A will be used whenever an isotonic crystalloid is ordered
Major Adverse Kidney Event Within 30 Days	659 Participants	615 Participants

SECONDARY outcome

Timeframe: 30 days after enrollment censored at hospital discharge

Death before hospital discharge, censored at 30 days after enrollment

Outcome measures

Outcome measures
Measure	0.9% Sodium Chloride (Saline) n=2646 Participants Patients in an ICU block randomized to saline will receive 0.9% sodium chloride whenever isotonic intravenous fluid administration is ordered by the treating provider. Saline: 0.9% sodium chloride will be used whenever an isotonic crystalloid is ordered	Balanced Crystalloid n=2735 Participants Patients in an ICU block randomized to balanced crystalloid will receive Plasma-Lyte A or Lactated Ringer's whenever isotonic intravenous crystalloid administration is ordered by the treating provider. Balanced crystalloid: Lactated Ringers or Plasma-Lyte A will be used whenever an isotonic crystalloid is ordered
30-day In-hospital Mortality	467 Participants	418 Participants

Adverse Events

0.9% Sodium Chloride (Saline)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 467 deaths

Balanced Crystalloid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 418 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Matthew W. Semler, MD, MSc

Vanderbilt University Medical Center

Phone: (615) 322-3412

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place