NCT05939518

Fluid Therapy and Glycocalyx Shedding During Moderate Surgery

The Contribution of Liberal Fluid Therapy to Glycocalyx Shedding, Interstitial Edema and Fluid Accumulation During Moderate Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Goal-directed fluid therapy is one of the most accepted strategies in intraoperative fluid therapy, although potential fluid overload is a possible drawback. Fluid overload has recently been shown to cause damage to the glycocalyx and to increase extravasation of fluids into the interstitial space. This study aims to determine whether liberal fluid administration during moderate surgery results in impairment to the endothelial glycocalyx and causes edema. Participants will be randomized to receive either a liberal or restrictive fluid protocol with vasopressor support. The investigators will measure interstitial edema by clinical signs, pulmonary congestion by ultrasound, and extracellular water by bioimpedance. Impairment of glycocalyx will be estimated by measuring blood levels of shedding markers. In addition, wound healing and early postoperative outcome will be estimated by POMS.

Conditions

• Abdominoplasty

Interventions

Type	Name	Description
OTHER	Lactated Ringer's Fluid Bolus Response to Low Urinary Output	During the surgical procedure and the subsequent stay in the Post-Anesthesia Care Unit: if the study participant's urine output (UO) remains \<0.3 ml/kg/h for two consecutive hours, an IV bolus of 250 ml of lactated Ringer's solution will be administered over 15 min and repeated every 30 min until the UO reaches \>0.3 ml/kg/h.
OTHER	Post-Anesthesia Care Unit Lactated Ringer's Fluid Management Protocol	During their stay in the Post-Anesthesia Care Unit, patients will receive a 1.5 ml/kg/h IV infusion of lactated Ringer's solution.

Timeline

• Start date: 2020-05-13
• Primary completion: 2023-08-03
• Completion: 2023-08-03
• First posted: 2023-07-11
• Last updated: 2024-12-18

Locations

1 site across 1 country: Israel