Phase 3 N=59 Randomized Treatment

Impact of Intraoperative Fluid Management on Electrolyte and Acid-base Variables

Anesthesia

Bottom Line

View on ClinicalTrials.gov: NCT03054922 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2020

Primary outcome: Primary: Change in Base Deficit — -1.5; -1.2; -0.5 mEq/L

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Normal Saline (Drug); Lactated Ringer (Drug); Normosol-R Inj (Drug)
Age: Pediatric, Adult · 10+ yrs
Sex: All
Sponsor: Nationwide Children's Hospital
Primary completion: Sep 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Base Deficit	-1.5; -1.2; -0.5	—
SECONDARY Change in Sodium	0.1; -0.4; -0.1	—
SECONDARY Change in Potassium	0.4; 0.7; 0.2	—
SECONDARY Change in Ionized Calcium	0.01; -0.13; -0.01	—
SECONDARY Change in pH	-0.03; -0.02; 0.01	—

Summary

During major surgical procedures, intravascular volume is maintained with the administration of isotonic fluids such as Lactated Ringers (LR), Normal Saline (NS) or Normosol-R. All three of these fluids are in common clinical use for this purpose. As large volumes of NS may result in a dilutional acidosis and an increasing base deficit, it may cloud clinical decision making when resuscitative efforts are guided by acid-base status on routine arterial blood gas analysis. This is a prospective, randomized study to evaluate changes in acid-base and electrolyte (sodium, potassium, calcium) status with the use of various isotonic fluids for intraoperative resuscitation.

Eligibility Criteria

Inclusion Criteria

Major surgical procedure requiring arterial access

Exclusion Criteria

Comorbid disease process that contraindicates the use of any 1 of the 3 crystalloid solutions.

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Data sourced from ClinicalTrials.gov (NCT03054922). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.