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

Phase 3

Completed

• Conditions: Anesthesia
• Interventions: Drug: Normal Saline; Drug: Lactated Ringer; Drug: Normosol-R Inj

• Registration Number: NCT03054922
• Lead Sponsor: Nationwide Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-13
• Study First Submitted QC: 2017-02-13
• Study First Posted: 2017-02-16
• Study Start: 2017-02-23
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30
• Status Verified: 2020-03
• Results First Submitted: 2020-03-11
• Results First Submitted QC: 2020-03-11
• Last Update Submitted: 2020-03-11
• Results First Posted: 2020-03-25
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	Normal Saline	0.9% Sodium Chloride
Lactated Ringers	Lactated Ringer	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
Normosol-R	Normosol-R Inj	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.

Primary Outcome Measures

Name	Time	Method
Change in Base Deficit	During surgery (typically 4-6 hrs in length)	Change in base deficit from 1st to 2nd blood gas to measure metabolic acidosis

Secondary Outcome Measures

Name	Time	Method
Change in Sodium	During surgery (typically 4-6 hrs in length)	Change in sodium electrolyte from 1st to 2nd blood gas
Change in Potassium	During surgery (typically 4-6 hrs in length)	Change in potassium electrolyte from 1st to 2nd blood gas
Change in pH	During surgery (typically 4-6 hrs in length)	Change in pH from 1st to 2nd blood gas
Change in Ionized Calcium	During surgery (typically 4-6 hrs in length)	Change in calcium electrolyte from 1st to 2nd blood gas

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States