- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03537898
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
Conditions
Intervention / Treatment
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:
|
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:
|
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
- 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.
- Finfer S, Liu B, Taylor C, Bellomo R, Billot L, Cook D, Du B, McArthur C, Myburgh J; SAFE TRIPS Investigators. Resuscitation fluid use in critically ill adults: an international cross-sectional study in 391 intensive care units. Crit Care. 2010;14(5):R185. doi: 10.1186/cc9293. Epub 2010 Oct 15.
- 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.
- Weinberg L, Chiam E, Hooper J, Liskaser F, Hawkins AK, Massie D, Ellis A, Tan CO, Story D, Bellomo R. Plasma-Lyte 148 vs. Hartmann's solution for cardiopulmonary bypass pump prime: a prospective double-blind randomized trial. Perfusion. 2018 May;33(4):310-319. doi: 10.1177/0267659117742479. Epub 2017 Nov 16.
- Weinberg L, Pearce B, Sullivan R, Siu L, Scurrah N, Tan C, Backstrom M, Nikfarjam M, McNicol L, Story D, Christophi C, Bellomo R. The effects of plasmalyte-148 vs. Hartmann's solution during major liver resection: a multicentre, double-blind, randomized controlled trial. Minerva Anestesiol. 2015 Dec;81(12):1288-97. Epub 2014 Nov 19.
- Shin WJ, Kim YK, Bang JY, Cho SK, Han SM, Hwang GS. Lactate and liver function tests after living donor right hepatectomy: a comparison of solutions with and without lactate. Acta Anaesthesiol Scand. 2011 May;55(5):558-64. doi: 10.1111/j.1399-6576.2011.02398.x. Epub 2011 Feb 22.
- Hadimioglu N, Saadawy I, Saglam T, Ertug Z, Dinckan A. The effect of different crystalloid solutions on acid-base balance and early kidney function after kidney transplantation. Anesth Analg. 2008 Jul;107(1):264-9. doi: 10.1213/ane.0b013e3181732d64.
- Hasman H, Cinar O, Uzun A, Cevik E, Jay L, Comert B. A randomized clinical trial comparing the effect of rapidly infused crystalloids on acid-base status in dehydrated patients in the emergency department. Int J Med Sci. 2012;9(1):59-64. doi: 10.7150/ijms.9.59. Epub 2011 Nov 23.
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
Additional Relevant MeSH Terms
Other Study ID 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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