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

NCT03054922 | Completed Phase 3 Results FDA Drug

• 1 other identifier: IRB16-01093
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Sodium

  During surgery (typically 4-6 hrs in length)

• Change in Potassium

  During surgery (typically 4-6 hrs in length)

• Change in Ionized Calcium

  During surgery (typically 4-6 hrs in length)

• Change in pH

  During surgery (typically 4-6 hrs in length)

Study Arms (3)

Normal Saline

ACTIVE COMPARATOR

0.9% Sodium Chloride

Drug: Normal Saline

Lactated Ringers

ACTIVE COMPARATOR

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

Normosol-R

ACTIVE COMPARATOR

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

Interventions

Normal Saline DRUG

IV infusion of 0.9% NaCl throughout surgery.

Also known as: 0.9% NaCl

Normal Saline

Lactated Ringer DRUG

IV infusion of lactated ringer throughout surgery.

Lactated Ringers

Normosol-R Inj DRUG

IV infusion of Normosol throughout surgery.

Normosol-R

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Major surgical procedure requiring arterial access

You may not qualify if:

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

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Interventions

Saline Solution; Ringer's Lactate

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: David P. Martin, MD
• Organization: Nationwide Children's Hospital

david.martin@nationwidechildrens.org

614-722-4200

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Acute Pain Services

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 16, 2017
• Study Start: February 23, 2017
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: March 25, 2020
• Results First Posted: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)