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Balanced Solutions and Plasma Electrolytes (BASE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03537898
Recruitment Status : Completed
First Posted : May 25, 2018
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Matthew Semler, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment Phase
Critical Illness Acidosis, Metabolic Other: Lactated Ringer's Other: Normosol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2093 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Balanced Solutions and Plasma Electrolytes in the Medical Intensive Care Unit
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : February 7, 2019
Actual Study Completion Date : March 2, 2019

Resource links provided by the National Library of Medicine


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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Plasma Bicarbonate Concentration < 20 mmol/L [ Time Frame: Between ICU admission and Day 7 ]
  2. Lowest Plasma Bicarbonate Concentration [ Time Frame: Between ICU admission and Day 7 ]
  3. Plasma Chloride Concentration > 110 mmol/L [ Time Frame: Between ICU admission and Day 7 ]
  4. Plasma Chloride Concentration < 100 mmol/L [ Time Frame: Between ICU admission and Day 7 ]
  5. Highest Plasma Chloride Concentration [ Time Frame: Between ICU admission and Day 7 ]
  6. Change in Plasma Chloride Concentration from Baseline to Peak [ Time Frame: Between ICU admission and Day 7 ]
  7. Plasma Sodium Concentration > 145 mmol/L [ Time Frame: Between ICU admission and Day 7 ]
  8. Plasma Sodium Concentration < 135 mmol/L [ Time Frame: Between ICU admission and Day 7 ]
  9. Plasma Potassium Concentration > 5.5 mmol/L [ Time Frame: Between ICU admission and Day 7 ]
  10. 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 ]
  11. Strong Ion Difference [ Time Frame: Between ICU admission and Day 7 ]
    (Sodium + Potassium + Calcium) - (Chloride + Lactate) in mmol/L

  12. Arterial pH [ Time Frame: Between ICU admission and Day 7 ]
  13. Arterial Standard Base Excess [ Time Frame: Between ICU admission and Day 7 ]
  14. 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)

  15. 30-Day In-Hospital Mortality [ Time Frame: 30 Days after Enrollment Censored at Hospital Discharge ]
  16. 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.

  17. 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

  18. 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.

  19. Total Volume of Blood Product Transfusion [ Time Frame: Between ICU admission and Day 7 ]
  20. Dose of Vasopressor [ Time Frame: Between ICU admission and Day 7 ]
    Dose of vasopressor (in norepinephrine equivalents, µg/kg/min)

  21. 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.

  22. 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.

  23. 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.

  24. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537898


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Study Director: Matthew W Semler, MD, MSc Vanderbilt University Medical Center
Publications:

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Responsible Party: Matthew Semler, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03537898    
Other Study ID Numbers: 180397
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Matthew Semler, Vanderbilt University Medical Center:
balanced crystalloid
crystalloid
isotonic
acetate
non-acetate
lactated Ringer's
Normosol
Additional relevant MeSH terms:
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Acidosis
Critical Illness
Disease Attributes
Pathologic Processes
Acid-Base Imbalance
Metabolic Diseases
Pharmaceutical Solutions
Plasma-lyte 148
Ophthalmic Solutions