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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03054922
• Other study ID #: IRB16-01093
• Status: Completed
• Phase: Phase 3
• Start date: February 23, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: March 2020
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Normal Saline
IV infusion of 0.9% NaCl throughout surgery.
• Lactated Ringer
IV infusion of lactated ringer throughout surgery.
• Normosol-R Inj
IV infusion of Normosol throughout surgery.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

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