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

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 Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Normal Saline; Drug: Lactated Ringer; Drug: Normosol-R Inj

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 21 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Normal Saline; 0.9% Sodium Chloride	Drug: Normal Saline; IV infusion of 0.9% NaCl throughout surgery.; Other Names: 0.9% NaCl
ACTIVE_COMPARATOR: 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	Drug: Lactated Ringer; IV infusion of lactated ringer throughout surgery.
ACTIVE_COMPARATOR: 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.	Drug: Normosol-R Inj; IV infusion of Normosol throughout surgery.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 23, 2017
• Primary Completion (ACTUAL): September 30, 2018
• Study Completion (ACTUAL): September 30, 2018

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: February 13, 2017
• First Posted (ACTUAL): February 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 11, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions; Ophthalmic Solutions; Plasma-lyte 148
• Other Study ID Numbers: IRB16-01093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No