Fluid Therapy and Glycocalyx Shedding During Moderate Surgery

NCT ID: NCT05939518

Last Updated: 2024-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-13
• Study Completion Date: 2023-08-03

Brief 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

Keywords

Glycocalyx; IV Fluids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Liberal Lactated Ringer Fluid Protocol with Ephedrine and Phenylephrine Boluses

IV Infusion of 500 ml of lactated Ringer's (RL) solution during the induction of anesthesia followed by an infusion of RL at a rate of 8.0 ml/kg/h throughout the maintenance phase of anesthesia. The anesthesia care provider will be allowed free use of IV boluses of ephedrine or phenylephrine to target a mean arterial blood pressure of \>60 mmHg.

Group Type: EXPERIMENTAL

Lactated Ringer's Fluid Bolus Response to Low Urinary Output

Intervention Type: OTHER

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.

Post-Anesthesia Care Unit Lactated Ringer's Fluid Management Protocol

Intervention Type: OTHER

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.

Restrictive Lactated Ringer Fluid Protocol with Noradrenaline Infusion

IV Infusion of 200 ml of lactated Ringer's (RL) solution during the induction of anesthesia followed by an infusion of RL at a rate of 2.0 ml/kg/h + an infusion of noradrenaline throughout the maintenance phase of anesthesia, through a large peripheral vein. The noradrenaline infusion rate will be titrated after an initial bolus of 10 μg, from an initial rate of 2.0 μg/kg/h, which may be raised up to 8.0 μg/kg/h, to target a mean arterial blood pressure (MBP) of \>60 mmHg. If the MBP target is still not achieved, the RL infusion rate may be increased up to 4.0 ml/kg/h.

Group Type: ACTIVE_COMPARATOR

Lactated Ringer's Fluid Bolus Response to Low Urinary Output

Intervention Type: OTHER

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.

Post-Anesthesia Care Unit Lactated Ringer's Fluid Management Protocol

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Recovery Room Fluid Management Protocol

Eligibility Criteria

Inclusion Criteria

• Patients scheduled for abdominoplasty.
• American Society of Anesthesiologists Classification 1 or 2.

Exclusion Criteria

• Pregnancy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebrew University of Jerusalem

OTHER

Sponsor Role: collaborator

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Galel Yakobi, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

Hadassah Ein-Carem Medical Center

Jerusalem, , Israel

Countries

Israel

Other Identifiers

008932_2020-05-12_MOH

Identifier Type: REGISTRY

Identifier Source: secondary_id

0388-19-HMO

Identifier Type: -

Identifier Source: org_study_id