NCT03054922

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Nationwide Children's Hospital · Academic / Other
• Sex: All
• Age: 10 Years – 21 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Normal Saline	IV infusion of 0.9% NaCl throughout surgery.
DRUG	Lactated Ringer	IV infusion of lactated ringer throughout surgery.
DRUG	Normosol-R Inj	IV infusion of Normosol throughout surgery.

Timeline

• Start date: 2017-02-23
• Primary completion: 2018-09-30
• Completion: 2018-09-30
• First posted: 2017-02-16
• Last updated: 2020-03-25
• Results posted: 2020-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study