Clinical trial NCT03537898: Balanced Solutions and Plasma Electrolytes
Official title: Balanced Solutions and Plasma Electrolytes in the Medical Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Acidosis, Metabolic
Keywords: balanced crystalloid
crystalloid
isotonic
acetate
non-acetate
lactated Ringer's
Normosol
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2018-05-25
Enrollment: 2093
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plasma Bicarbonate Concentration
timeFrame: Between ICU admission and Day 7
Secondary outcomes:
measure: Plasma Bicarbonate Concentration < 20 mmol/L
timeFrame: Between ICU admission and Day 7
measure: Lowest Plasma Bicarbonate Concentration
timeFrame: Between ICU admission and Day 7
measure: Plasma Chloride Concentration > 110 mmol/L
timeFrame: Between ICU admission and Day 7
measure: Plasma Chloride Concentration < 100 mmol/L
timeFrame: Between ICU admission and Day 7
measure: Highest Plasma Chloride Concentration
timeFrame: Between ICU admission and Day 7
measure: Change in Plasma Chloride Concentration from Baseline to Peak
timeFrame: Between ICU admission and Day 7
measure: Plasma Sodium Concentration > 145 mmol/L
timeFrame: Between ICU admission and Day 7
measure: Plasma Sodium Concentration < 135 mmol/L
timeFrame: Between ICU admission and Day 7
measure: Plasma Potassium Concentration > 5.5 mmol/L
timeFrame: Between ICU admission and Day 7
measure: Plasma values for Sodium, Potassium, Chloride, Bicarbonate, Blood Urea Nitrogen, Creatinine, Calcium, and Lactate
timeFrame: Between ICU admission and Hospital Discharge or 30 Days
measure: Strong Ion Difference
timeFrame: Between ICU admission and Day 7
measure: Arterial pH
timeFrame: Between ICU admission and Day 7
measure: Arterial Standard Base Excess
timeFrame: Between ICU admission and Day 7
measure: Major Adverse Kidney Events within 30 days
timeFrame: 30 Days after Enrollment Censored at Hospital Discharge
measure: 30-Day In-Hospital Mortality
timeFrame: 30 Days after Enrollment Censored at Hospital Discharge
measure: New Renal Replacement Therapy
timeFrame: 30 Days after Enrollment Censored at Hospital Discharge
measure: Stage II or Higher Acute Kidney Injury
timeFrame: Between ICU admission and Day 7
measure: Persistent Renal Dysfunction
timeFrame: 30 Days after Enrollment Censored at Hospital Discharge
measure: Total Volume of Blood Product Transfusion
timeFrame: Between ICU admission and Day 7
measure: Dose of Vasopressor
timeFrame: Between ICU admission and Day 7
measure: Intensive Care Unit-Free Days
timeFrame: Between ICU admission and Day 28
measure: Vasopressor-Free Days
timeFrame: Between ICU admission and Day 28
measure: Renal Replacement Therapy-Free Days
timeFrame: Between ICU admission and Day 28
measure: Ventilator-Free Days
timeFrame: Between ICU admission and Day 28
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Matthew W Semler, MD, MSc
role: STUDY_DIRECTOR
References:
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citation: Semler MW, Self WH, Wanderer JP, Ehrenfeld JM, Wang L, Byrne DW, Stollings JL, Kumar AB, Hughes CG, Hernandez A, Guillamondegui OD, May AK, Weavind L, Casey JD, Siew ED, Shaw AD, Bernard GR, Rice TW; SMART Investigators and the Pragmatic Critical Care Research Group. Balanced Crystalloids versus Saline in Critically Ill Adults. N Engl J Med. 2018 Mar 1;378(9):829-839. doi: 10.1056/NEJMoa1711584. Epub 2018 Feb 27.
citation: Self WH, Semler MW, Wanderer JP, Wang L, Byrne DW, Collins SP, Slovis CM, Lindsell CJ, Ehrenfeld JM, Siew ED, Shaw AD, Bernard GR, Rice TW; SALT-ED Investigators. Balanced Crystalloids versus Saline in Noncritically Ill Adults. N Engl J Med. 2018 Mar 1;378(9):819-828. doi: 10.1056/NEJMoa1711586. Epub 2018 Feb 27.
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