Balanced Solutions and Plasma Electrolytes

NCT03537898 | Completed

• 1 other identifier: 180397
• Study Type: interventional
• Target: 2,093
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Acidosis, Metabolic

Keywords

balanced crystalloid; crystalloid; isotonic; acetate; non-acetate; lactated Ringer's; Normosol

Outcome Measures

Primary Outcomes (1)

• Plasma Bicarbonate Concentration

  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 Outcomes (24)

• Plasma Bicarbonate Concentration < 20 mmol/L

  Between ICU admission and Day 7

• Lowest Plasma Bicarbonate Concentration

  Between ICU admission and Day 7

• Plasma Chloride Concentration > 110 mmol/L

  Between ICU admission and Day 7

• Plasma Chloride Concentration < 100 mmol/L

  Between ICU admission and Day 7

• Highest Plasma Chloride Concentration

  Between ICU admission and Day 7

Study Arms (2)

Lactated Ringer's

ACTIVE COMPARATOR

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

Normosol

ACTIVE COMPARATOR

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

Interventions

Lactated Ringer's OTHER

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

Also known as: Ringer's lactate, Non-acetate buffered solution

Lactated Ringer's

Normosol OTHER

Normosol-R pH 7.4 will be used whenever an isotonic crystalloid is ordered

Also known as: Normosol-R, Normosol-R pH 7.4, Acetate buffered solution

Normosol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Age \< 18 years old
• Prisoners

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (9)

• 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.

  PMID: 20950434 BACKGROUND

• 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.

  PMID: 29485925 BACKGROUND

• 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.

  PMID: 29485926 BACKGROUND

• 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.

  PMID: 29144182 BACKGROUND

• 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.

  PMID: 25407026 BACKGROUND

• 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.

  PMID: 21342149 BACKGROUND

• 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.

  PMID: 18635497 BACKGROUND

• 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.

  PMID: 22211091 BACKGROUND

• Qian ET, Brown RM, Jackson KE, Wang L, Stollings JL, Freundlich RE, Wanderer JP, Siew ED, Bernard GR, Self WH, Casey JD, Rice TW, Semler MW; Pragmatic Critical Care Research Group. Normosol-R vs Lactated Ringers in the Critically Ill: A Randomized Trial. Chest. 2025 Aug;168(2):336-345. doi: 10.1016/j.chest.2025.02.008. Epub 2025 Feb 17.

  PMID: 39971001 DERIVED

MeSH Terms

Conditions

Critical Illness; Acidosis

Interventions

Ringer's Lactate; normosol R; Plasmalyte A

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Matthew W Semler, MD, MSc

  Vanderbilt University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: May 25, 2018
• Study Start: June 1, 2018
• Primary Completion: February 7, 2019
• Study Completion: March 2, 2019
• Last Updated: October 11, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)