Impact of Intraoperative Fluid Management on Electrolyte and Acid-base Variables
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- Change in Base Deficit
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Normal Saline
0.9% Sodium Chloride
Intervention: Normal Saline (Drug)
Lactated Ringers
Each 100 mL of Lactated Ringer's Injection USP contains:
Sodium Chloride USP 0.6 g; Sodium Lactate USP 0.31 g; Potassium Chloride USP 0.03 g; Calcium Chloride Dihydrate USP 0.02 g; Water for Injection USP qs
Intervention: Lactated Ringer (Drug)
Normosol-R
Each 100 mL of Normosol-R contains sodium chloride, 526 mg; sodium acetate, 222 mg; sodium gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride hexahydrate, 30 mg.
Intervention: Normosol-R Inj (Drug)
Outcomes
Primary Outcomes
Change in Base Deficit
Time Frame: During surgery (typically 4-6 hrs in length)
Change in base deficit from 1st to 2nd blood gas to measure metabolic acidosis
Secondary Outcomes
- Change in Sodium(During surgery (typically 4-6 hrs in length))
- Change in Potassium(During surgery (typically 4-6 hrs in length))
- Change in pH(During surgery (typically 4-6 hrs in length))
- Change in Ionized Calcium(During surgery (typically 4-6 hrs in length))
Investigators
David P. Martin
Director, Acute Pain Services
Nationwide Children's Hospital