Trial Outcomes & Findings for Isotonic Solutions and Major Adverse Renal Events Trial in the Non-Medical Intensive Care Unit (SMART-SURG) (NCT NCT02547779)

Last Updated: 2019-11-25

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

10421 participants

Primary outcome timeframe

30 days after enrollment censored at hospital discharge

Results posted on

2019-11-25

Participant Flow

The Isotonic Solutions and Major Adverse Events Trial (SMART) was registered for the medical ICU (NCT02444988), which enrolled 5381 patient beginning on June 1 2015, and then for the surgical ICUs (NCT02547779), which enrolled 10,421 patients beginning on October 1 2015. The overall SMART trial enrolled 15,802 patients and ended on April 30 2017.

Participant milestones

Participant milestones
Measure	0.9% Sodium Chloride Patients in an ICU block randomized to saline will receive 0.9% sodium chloride whenever isotonic intravenous crystalloid administration is ordered by the treating provider. Saline: 0.9% sodium chloride will be used whenever an isotonic crystalloid is ordered	Balanced Crystalloids Patients in an ICU block randomized to balanced crystalloids 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	5214	5207
Overall Study COMPLETED	5214	5207
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 Non-Medical Intensive Care Unit (SMART-SURG)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0.9% Sodium Chloride n=5214 Participants Patients in an ICU block randomized to saline will receive 0.9% sodium chloride whenever isotonic intravenous crystalloid administration is ordered by the treating provider. Saline: 0.9% sodium chloride will be used whenever an isotonic crystalloid is ordered	Balanced Crystalloids n=5207 Participants Patients in an ICU block randomized to balanced crystalloids 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=10421 Participants Total of all reporting groups
Age, Continuous	57 years n=5 Participants	57 years n=7 Participants	57 years n=5 Participants
Sex: Female, Male Female	2052 Participants n=5 Participants	2108 Participants n=7 Participants	4160 Participants n=5 Participants
Sex: Female, Male Male	3162 Participants n=5 Participants	3099 Participants n=7 Participants	6261 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	4344 Participants n=5 Participants	4352 Participants n=7 Participants	8696 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	870 Participants n=5 Participants	855 Participants n=7 Participants	1725 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days after enrollment censored at hospital discharge

Population: Of 15,802 patients in the SMART trial, 7,860 were assigned to saline and 7,942 were assigned to balanced crystalloids, of whom 10,421 were enrolled to surgical ICUs with 5,214 assigned to saline and 5,207 assigned to balanced crystalloids.

Outcome measures

Outcome measures
Measure	0.9% Sodium Chloride n=5214 Participants Patients in an ICU block randomized to saline will receive 0.9% sodium chloride whenever isotonic intravenous crystalloid administration is ordered by the treating provider. Saline: 0.9% sodium chloride will be used whenever an isotonic crystalloid is ordered	Balanced Crystalloids n=5207 Participants Patients in an ICU block randomized to balanced crystalloids 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	551 Participants	524 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 n=5214 Participants Patients in an ICU block randomized to saline will receive 0.9% sodium chloride whenever isotonic intravenous crystalloid administration is ordered by the treating provider. Saline: 0.9% sodium chloride will be used whenever an isotonic crystalloid is ordered	Balanced Crystalloids n=5207 Participants Patients in an ICU block randomized to balanced crystalloids 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	408 Participants	400 Participants

Adverse Events

0.9% Sodium Chloride

Serious events: 0 serious events

Other events: 0 other events

Deaths: 408 deaths

Balanced Crystalloids

Serious events: 0 serious events

Other events: 1 other events

Deaths: 400 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	0.9% Sodium Chloride n=5214 participants at risk Patients in an ICU block randomized to saline will receive 0.9% sodium chloride whenever isotonic intravenous crystalloid administration is ordered by the treating provider. Saline: 0.9% sodium chloride will be used whenever an isotonic crystalloid is ordered	Balanced Crystalloids n=5207 participants at risk Patients in an ICU block randomized to balanced crystalloids 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
Renal and urinary disorders Adverse Event	0.00% 0/5214 • 30 days An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered an intervention that does not necessarily have to have a causal relationship with this treatment. An adverse event therefore can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an intervention, whether or not the incident is considered to be related to the intervention.	0.02% 1/5207 • Number of events 1 • 30 days An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered an intervention that does not necessarily have to have a causal relationship with this treatment. An adverse event therefore can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an intervention, whether or not the incident is considered to be related to the intervention.

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