Effect of Intravenous Fluid Treatment With a Balanced Solution vs 0.9% Saline Solution on Mortality in Critically Ill Patients: The BaSICS Randomized Clinical Trial
Clinical Question
In critically ill patients, does the use of balanced intravenous solutions when compared to saline intravenous solution (0.9% sodium chloride) have an effect on 90-day mortality?
Bottom Line
Among critically ill patients, the use of balanced intravenous solutions compared to saline intravenous solutions (0.9% sodium chloride) did not have an effect on the 90 day mortality.
Major Points
Several small and large randomized trials in diabetics had previously suggested a sizable benefit of tight glycemic control in reducing cardiovascular risk. The ACCORD trial was the largest study of its kind and demonstrated that not only does euglycemia (ie, HbA1c <6%) not reduce cardiovascular risk, it also is associated with a trend towards increased mortality.
Guidelines
Design
- Multicenter, double-blind, parallel-group, randomized, controlled trial
- N=10,251
- Intensive (n=5,128)
- Standard (n=5,123)
- Setting: 77 centers in Canada and the United States
- Enrollment: January to June 2001, February 2003 to October 2005
- Mean follow-up: 3.5 years
- Analysis: Intention-to-treat
- Primary outcome:
Population
Inclusion Criteria
- Type 2 diabetes mellitus
- Hemoglobin A1c ≥7.5%
- Age 40-79 years with CAD or 55-79 years with
- Anatomical evidence of significant atherosclerosis
- Albuminuria
- LVH
- ≥2 cardiovascular risk factors (dyslipidemia, HTN, current smoking, obesity)
Exclusion Criteria
- Frequent or recent serious hypoglycemic events
- Unwillingness to perform home glucose monitoring or insulin injections
- BMI >45
- Cr >1.5mg/dl
- Serious illness
Baseline Characteristics
- Mean age: 72 years
- Mean BMI: 28
- Mean HbA1c: 8.8%
- Units of insulin: 14 units/day
Interventions
- Randomized to intensive (targeting HbA1c <6%) or standard (HbA1c 7-7.9%) glycemic therapy
- Then 46% were randomized to intensive (SBP <120) vs. standard (SBP <140) blood pressure therapy
- Remaining 54% randomized to fenofibrate vs. placebo; all received statin
- Intensive glycemic control group attended monthly visits for 4 months, then every 2 months, with additional visits and telephone calls as needed
- Standard therapy group had glycemic control visits every 4 months
Outcomes
Comparisons are intensive therapy vs. standard therapy.
Primary Outcomes
- Annual rate of nonfatal MI or nonfatal stroke or cardiovascular death
- 2.11% vs. 2.29% (HR 0.90; 95% CI 0.78-1.04; P=0.16)
Secondary Outcomes
- Annual rate of death from any cause
- 1.41% vs. 1.14% (HR 1.22; 95% CI 1.01-1.46; P=0.04)
- Annual rate of cardiovascular death
- 0.79% vs. 0.56% (HR 1.35; 95% CI 1.04-1.76; P=0.02)