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Completed

NCT Number: NCT03537898

Balanced Solutions and Plasma Electrolytes

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactated Ringer's

Other

Lactated Ringer's will be used whenever an isotonic crystalloid is ordered

Other names: Ringer's lactate, Non-acetate buffered solution

Normosol

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Balanced Solutions and Plasma Electrolytes in the Medical Intensive Care Unit

Acronym: BASE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 25, 2018
Registry last updated
Oct 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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