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

• ClinicalTrials.gov Identifier: NCT03054922
• Recruitment Status: Completed
• First Posted: February 16, 2017
• Results First Posted: March 25, 2020
• Last Update Posted: March 25, 2020
• Sponsor: Nationwide Children's Hospital
• Information provided by (Responsible Party): David P. Martin, Nationwide Children's Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Anesthesia	Drug: Normal Saline; Drug: Lactated Ringer; Drug: Normosol-R Inj	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 59 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Impact of Intraoperative Fluid Management on Electrolyte and Acid-base Variables
• Actual Study Start Date: February 23, 2017
• Actual Primary Completion Date: September 30, 2018
• Actual Study Completion Date: September 30, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Normal Saline; 0.9% Sodium Chloride	Drug: Normal Saline; IV infusion of 0.9% NaCl throughout surgery.; Other Name: 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.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Change in Sodium [ Time Frame: During surgery (typically 4-6 hrs in length) ]
   Change in sodium electrolyte from 1st to 2nd blood gas
2. Change in Potassium [ Time Frame: During surgery (typically 4-6 hrs in length) ]
   Change in potassium electrolyte from 1st to 2nd blood gas
3. Change in Ionized Calcium [ Time Frame: During surgery (typically 4-6 hrs in length) ]
   Change in calcium electrolyte from 1st to 2nd blood gas
4. Change in pH [ Time Frame: During surgery (typically 4-6 hrs in length) ]
   Change in pH from 1st to 2nd blood gas

Eligibility Criteria

• Ages Eligible for Study: 10 Years to 21 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Ohio

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

Sponsors and Collaborators

Nationwide Children's Hospital

  Study Documents (Full-Text)

Documents provided by David P. Martin, Nationwide Children's Hospital:

Study Protocol and Statistical Analysis Plan  [PDF] February 17, 2017

More Information

• Responsible Party: David P. Martin, Director, Acute Pain Services, Nationwide Children's Hospital
• ClinicalTrials.gov Identifier: NCT03054922
• Other Study ID Numbers: IRB16-01093
• First Posted: February 16, 2017
• Results First Posted: March 25, 2020
• Last Update Posted: March 25, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Plasma-lyte 148; Ophthalmic Solutions; Pharmaceutical Solutions