Balanced Solutions and Plasma Electrolytes
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/21/2019 |
| Start Date: | June 1, 2018 |
| End Date: | March 2, 2019 |
Balanced Solutions and Plasma Electrolytes in the Medical Intensive Care Unit
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.
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.
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.
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.
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
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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