Balanced Solutions and Plasma Electrolytes (BASE)

October 8, 2019 updated by: Matthew Semler, Vanderbilt University Medical Center

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.

Study Overview

Status

Completed

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 Type

Interventional

Enrollment (Actual)

2093

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Lactated Ringer's will be used whenever an isotonic crystalloid is ordered
Other Names:
  • Ringer's lactate
  • Non-acetate buffered solution
Active Comparator: 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.
Normosol-R pH 7.4 will be used whenever an isotonic crystalloid is ordered
Other Names:
  • Normosol-R
  • Normosol-R pH 7.4
  • Acetate buffered solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Between ICU admission and Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Bicarbonate Concentration < 20 mmol/L
Time Frame: Between ICU admission and Day 7
Between ICU admission and Day 7
Lowest Plasma Bicarbonate Concentration
Time Frame: Between ICU admission and Day 7
Between ICU admission and Day 7
Plasma Chloride Concentration > 110 mmol/L
Time Frame: Between ICU admission and Day 7
Between ICU admission and Day 7
Plasma Chloride Concentration < 100 mmol/L
Time Frame: Between ICU admission and Day 7
Between ICU admission and Day 7
Highest Plasma Chloride Concentration
Time Frame: Between ICU admission and Day 7
Between ICU admission and Day 7
Change in Plasma Chloride Concentration from Baseline to Peak
Time Frame: Between ICU admission and Day 7
Between ICU admission and Day 7
Plasma Sodium Concentration > 145 mmol/L
Time Frame: Between ICU admission and Day 7
Between ICU admission and Day 7
Plasma Sodium Concentration < 135 mmol/L
Time Frame: Between ICU admission and Day 7
Between ICU admission and Day 7
Plasma Potassium Concentration > 5.5 mmol/L
Time Frame: Between ICU admission and Day 7
Between ICU admission and Day 7
Plasma values for Sodium, Potassium, Chloride, Bicarbonate, Blood Urea Nitrogen, Creatinine, Calcium, and Lactate
Time Frame: Between ICU admission and Hospital Discharge or 30 Days
Between ICU admission and Hospital Discharge or 30 Days
Strong Ion Difference
Time Frame: Between ICU admission and Day 7
(Sodium + Potassium + Calcium) - (Chloride + Lactate) in mmol/L
Between ICU admission and Day 7
Arterial pH
Time Frame: Between ICU admission and Day 7
Between ICU admission and Day 7
Arterial Standard Base Excess
Time Frame: Between ICU admission and Day 7
Between ICU admission and Day 7
Major Adverse Kidney Events within 30 days
Time Frame: 30 Days after Enrollment Censored at Hospital Discharge
This composite outcome will be considered present if at least one of the following occur: (1) A patient dies prior to the earlier of hospital discharge or day 30; (2) A patient receives new renal replacement therapy between enrollment and day 30, or (3) A patient has persistent renal dysfunction at the earlier of hospital discharge or day 30 (persistent renal dysfunction is defined as ≥ 200% of creatinine from baseline)
30 Days after Enrollment Censored at Hospital Discharge
30-Day In-Hospital Mortality
Time Frame: 30 Days after Enrollment Censored at Hospital Discharge
30 Days after Enrollment Censored at Hospital Discharge
New Renal Replacement Therapy
Time Frame: 30 Days after Enrollment Censored at Hospital Discharge
The initiation of any renal replacement therapy between enrollment and 30 days censored at hospital discharge in a patient not known to have previously received renal replacement therapy.
30 Days after Enrollment Censored at Hospital Discharge
Stage II or Higher Acute Kidney Injury
Time Frame: Between ICU admission and Day 7
A patient will meet this outcome if they meet Kidney Disease Improving Global Outcomes (KDIGO) creatinine criteria for stage II acute kidney injury or higher
Between ICU admission and Day 7
Persistent Renal Dysfunction
Time Frame: 30 Days after Enrollment Censored at Hospital Discharge
Final creatinine value before discharge or 30 days after enrollment ≥ 200% of baseline creatinine.
30 Days after Enrollment Censored at Hospital Discharge
Total Volume of Blood Product Transfusion
Time Frame: Between ICU admission and Day 7
Between ICU admission and Day 7
Dose of Vasopressor
Time Frame: Between ICU admission and Day 7
Dose of vasopressor (in norepinephrine equivalents, µg/kg/min)
Between ICU admission and Day 7
Intensive Care Unit-Free Days
Time Frame: Between ICU admission and Day 28
Intensive care unit-free days to day 28 (ICU-free days) will be defined as the number of days from the time of the patient's physical transfer out of the ICU until day 28 after enrollment. Patients who die prior to day 28 after enrollment received a value of 0 for ICU-free days. Patients who never transfer out of the ICU prior to day 28 after enrollment will receive a value of 0 for ICU-free days. Patients who transferred out of the ICU, return to the ICU, and are not subsequently transferred out of the ICU again before day 28 after enrollment will receive a value of 0 for ICU-free days. For patients who transfer out of the ICU, are readmitted to the ICU, and subsequently transfer out of the ICU again prior to day 28 after enrollment, ICU-free days will be awarded based on the time of the final transfer out of the ICU prior to day 28 after enrollment.
Between ICU admission and Day 28
Vasopressor-Free Days
Time Frame: Between ICU admission and Day 28
Vasopressor-free days to day 28 will be defined as the number of days from the time of vasopressor cessation until day 28 after enrollment. Patients who die prior to day 28 after enrollment will receive a value of 0 for vasopressor-free days. Patients who never cease to receive vasopressors prior to day 28 after enrollment receive a value of 0 for vasopressor-free days. Patients who achieve vasopressor cessation, return to receiving vasopressors, and do not again achieve vasopressor cessation before day 28 after enrollment receive a value of 0 for vasopressor-free days. For patients who achieve vasopressor cessation, return to receiving vasopressors, and subsequently achieve cessation of vasopressors again prior to day 28 after enrollment, vasopressor-free days will be awarded based on the time of the final cessation of vasopressors prior to day 28 after enrollment. Survivors who never receive vasopressors received 28 vasopressor-free days.
Between ICU admission and Day 28
Renal Replacement Therapy-Free Days
Time Frame: Between ICU admission and Day 28
Renal replacement therapy-free days to day 28 (RRT- free days) will be defined as the number of days from the time of the final RRT treatment until day 28 after enrollment. Patients who die prior to day 28 after enrollment receive a value of 0 for RRT-free days. Patients who continue to receive RRT through day 28 after enrollment receive a value of 0 for RRT-free days. Patients who achieve RRT cessation, return to receiving RRT, and do not again achieve RRT cessation before day 28 after enrollment receive a value of 0 for RRT-free days. For patients who achieve RRT cessation, return to receiving RRT, and subsequently achieve cessation of RRT again prior to day 28 after enrollment, RRT-free days will be awarded based on the time of the final RRT treatment prior to day 28 after enrollment. Survivors who never receive RRT will be awarded 28 RRT-free days.
Between ICU admission and Day 28
Ventilator-Free Days
Time Frame: Between ICU admission and Day 28
Ventilator-free days to day 28 (VFDs) will be defined as the number of days from the time of initiating unassisted breathing (breathing without support of the mechanical ventilator) until day 28 after enrollment. Patients who die prior to day 28 after enrollment will receive a value of 0 for VFDs. Patients who never achieve unassisted breathing prior to day 28 after enrollment will receive a value of 0 for VFDs. Patients who achieve unassisted breathing, returned to assisted breathing, and do not again achieve unassisted breathing before day 28 after enrollment will receive a value of 0 for VFDs. For patients who achieve unassisted breathing, return to assisted breathing, and subsequently achieve unassisted breathing again prior to day 28 after enrollment, VFDs will be awarded based on the time of the final initiation of unassisted breathing prior to day 28 after enrollment. Survivors who never experience assisted breathing will receive 28 VFDs.
Between ICU admission and Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

February 7, 2019

Study Completion (Actual)

March 2, 2019

Study Registration Dates

First Submitted

May 14, 2018

First Submitted That Met QC Criteria

May 14, 2018

First Posted (Actual)

May 25, 2018

Study Record Updates

Last Update Posted (Actual)

October 11, 2019

Last Update Submitted That Met QC Criteria

October 8, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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