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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2093

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Lactated Ringer's
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.
Other: Normosol
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vanderbilt University Medical Center

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 7, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 2, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 11, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 180397

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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