Balanced Solutions and Plasma Electrolytes in the Medical Intensive Care Unit
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 2,093
- Locations
- 1
- Primary Endpoint
- Plasma Bicarbonate Concentration
Study Overview
Brief Summary
The administration of intravenous fluids is ubiquitous in the care of the critically ill. Commonly available isotonic crystalloid solutions contain a broad spectrum electrolyte compositions including a range chloride concentrations. Recent prospective, randomized trials have shown improved patient outcomes with the use of balanced crystalloids compared to saline. There have not been large randomized studies comparing acetate buffered balanced crystalloids to non-acetate buffered balanced crystalloids in the critically ill. BASE will be a pilot study for a large, cluster-randomized, multiple-crossover trial enrolling critically ill patients from the Medical ICU at Vanderbilt University from June 2018 until January 2019. The primary endpoint will be plasma bicarbonate concentration between Intensive Care Unit admission and hospital discharge.
Detailed Description
BASE is a pilot, cluster-randomized, multiple-crossover trial of lactated Ringer's versus Normosol-R pH 7.4 with regard to plasma bicarbonate concentration between intensive care unit admission and hospital discharge among all patients admitted to the medical intensive care unit. Between June 2018 and January 2019, all patients admitted to the medical intensive care unit at Vanderbilt University Medical Center who are 18 years or older will be enrolled. The study will occur in one-month blocks. The medical intensive care unit (MICU) will be randomized to an initial fluid group (lactated Ringer's or Normosol). The assigned fluid will be used exclusively for all patients receiving isotonic crystalloid for the duration of the month-long block (except in the presence of pre-specified contraindications). The assigned study fluid will switch at the end of each month-long block such that half of hte months are assigned to lactated Ringer's and half of the months are assigned to Normosol-R pH 7.4. It is anticipated that around 2,000 patients will be enrolled from the medical ICU during the study period. The primary outcome analysis will be an intention-to-treat comparison of the primary outcome of bicarbonate concentration (mmol/L) between enrollment and 7 days after enrollment between the lactated Ringer's and Normosol-R groups using generalized estimating equations with a random effect for study period and accounting for repeated measures.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients admitted to the Medical ICU during the study period (Enrolled patients who are discharged from the hospital are eligible again if they are readmitted to the Medical ICU during the study period)
Exclusion Criteria
- •Age < 18 years old
- •Prisoners
Arms & Interventions
Lactated Ringer's
Patients in a MICU block randomized to lactated Ringer's will receive lactated Ringer's whenever isotonic intravenous fluid administration is ordered by the treating provider.
Intervention: Lactated Ringer's (Other)
Normosol
Patients in a MICU block randomized to Normosol will receive Normosol-R pH 7.4 whenever isotonic intravenous fluid administration is ordered by the treating provider.
Intervention: Normosol (Other)
Outcomes
Primary Outcomes
Plasma Bicarbonate Concentration
Time Frame: Between ICU admission and Day 7
The primary outcome is a repeated measures variable of plasma bicarbonate concentration (mmol/L) between ICU admission and 7 days.
Secondary Outcomes
- Arterial pH(Between ICU admission and Day 7)
- Plasma Bicarbonate Concentration < 20 mmol/L(Between ICU admission and Day 7)
- Plasma Chloride Concentration < 100 mmol/L(Between ICU admission and Day 7)
- Total Volume of Blood Product Transfusion(Between ICU admission and Day 7)
- Plasma Sodium Concentration < 135 mmol/L(Between ICU admission and Day 7)
- Plasma values for Sodium, Potassium, Chloride, Bicarbonate, Blood Urea Nitrogen, Creatinine, Calcium, and Lactate(Between ICU admission and Hospital Discharge or 30 Days)
- Strong Ion Difference(Between ICU admission and Day 7)
- Arterial Standard Base Excess(Between ICU admission and Day 7)
- Major Adverse Kidney Events within 30 days(30 Days after Enrollment Censored at Hospital Discharge)
- New Renal Replacement Therapy(30 Days after Enrollment Censored at Hospital Discharge)
- Ventilator-Free Days(Between ICU admission and Day 28)
- Lowest Plasma Bicarbonate Concentration(Between ICU admission and Day 7)
- Plasma Chloride Concentration > 110 mmol/L(Between ICU admission and Day 7)
- Plasma Sodium Concentration > 145 mmol/L(Between ICU admission and Day 7)
- 30-Day In-Hospital Mortality(30 Days after Enrollment Censored at Hospital Discharge)
- Dose of Vasopressor(Between ICU admission and Day 7)
- Highest Plasma Chloride Concentration(Between ICU admission and Day 7)
- Stage II or Higher Acute Kidney Injury(Between ICU admission and Day 7)
- Persistent Renal Dysfunction(30 Days after Enrollment Censored at Hospital Discharge)
- Intensive Care Unit-Free Days(Between ICU admission and Day 28)
- Renal Replacement Therapy-Free Days(Between ICU admission and Day 28)
- Change in Plasma Chloride Concentration from Baseline to Peak(Between ICU admission and Day 7)
- Plasma Potassium Concentration > 5.5 mmol/L(Between ICU admission and Day 7)
- Vasopressor-Free Days(Between ICU admission and Day 28)
Investigators
Matthew Semler
Assistant Professor
Vanderbilt University Medical Center