"Balanced Crystalloids versus Saline in Critically Ill Adults". The New England Journal of Medicine. 2018. 378:829-839. PubMed • Full text • PDF

Contents

1 Clinical Question
2 Bottom Line
3 Major Points
4 Guidelines
5 Design
6 Population
6.1 Inclusion Criteria
6.2 Exclusion Criteria
6.3 Baseline Characteristics
7 Interventions
8 Outcomes
8.1 Primary Outcomes
8.2 Secondary Outcomes
9 Funding
10 Further Reading

Clinical Question

In critically ill adults requiring intravenous fluid administration, does the use of balanced crystalloids compared to saline result in better clinical outcomes?

Bottom Line

Among critically ill adults, the use of balanced crystalloids for intravenous fluid administration resulted in a lower rate of a composite outcome of death, new renal-replacement therapy, or persistent renal dysfunction than the use of saline.

Major Points

The selection of intravenous fluid, particularly between balanced crystalloids and saline, has been debated with regards to their impact on patient outcomes in critically ill adults. This study showed that balanced crystalloids reduced the composite outcome of death from any cause, new renal-replacement therapy, or persistent renal dysfunction in comparison to saline.

Guidelines

There are no guidelines that specifically reflect the results of this trial as of the knowledge cutoff date.

Design

- Multicenter, pragmatic, unblinded, cluster-randomized, multiple-crossover trial
- N=15,802 critically ill adults
- Randomized to either balanced crystalloids (lactated Ringer’s solution or Plasma-Lyte A) or saline (0.9% sodium chloride)
- Setting: 5 ICUs at an academic center
- Period: June 1, 2015, to April 30, 2017
- Analysis: Modified intention-to-treat
- Primary outcome: Major adverse kidney event within 30 days

Population

Inclusion Criteria

- Adults (18 years of age or older) admitted to a participating ICU
- Patients eligible to be re-enrolled if re-admitted to a participating ICU

Exclusion Criteria

- No explicit exclusions beyond age limitation were mentioned

Baseline Characteristics

- Median Age: 58 years
- Male: 57.6%
- On mechanical ventilation: 35%
- On vasopressors: 25%

Interventions

- Patients in the balanced-crystalloids group received lactated Ringer’s solution or Plasma-Lyte A
- Patients in the saline group received 0.9% sodium chloride
- Electronic advisor guided the providers as per assigned crystalloid, taking into account relative contraindications
- Clinician determined if unassigned crystalloid was required for any patient

Outcomes

Primary Outcomes

- Composite of death from any cause, new renal-replacement therapy, or persistent renal dysfunction at 30 days:
- Balanced crystalloids: 14.3%
- Saline: 15.4% (marginal odds ratio, 0.91; 95% CI, 0.84 to 0.99; P=0.04)

Secondary Outcomes

- In-hospital mortality at 30 days:
- Balanced crystalloids: 10.3%
- Saline: 11.1% (P=0.06)
- New renal-replacement therapy:
- Balanced crystalloids: 2.5%
- Saline: 2.9% (P=0.08)
- Persistent renal dysfunction:
- Balanced crystalloids: 6.4%
- Saline: 6.6% (P=0.60)

Funding

The trial was funded by the Vanderbilt Institute for Clinical and Translational Research, the National Center for Advancing Translational Sciences, the National Heart, Lung, and Blood Institute, the National Institute of General Medical Sciences, the American Geriatrics Society, the Department of Defense, and other sources.

Further Reading

For additional information and details on the trial, "Balanced Crystalloids versus Saline in Critically Ill Adults" can be accessed through the cited medical journal or clinical trials registry.