Completed

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

What is being tested

Lactated Ringer's Fluid Bolus Response to Low Urinary Output

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

Other

Who is being recruted

From 18 to 80 Years

+3 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Basic Science Study

Interventional

Study Start: May 2020

See protocol details

Summary

Principal SponsorHadassah Medical Organization

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: May 13, 2020

Actual date on which the first participant was enrolled.

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.

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

NCT05939518

Principal SponsorHadassah Medical Organization

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

51 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate

Patients scheduled for abdominoplasty.

American Society of Anesthesiologists Classification 1 or 2.

1 exclusion criteria prevent from participating

Pregnancy.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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 II

Active Comparator

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Hadassah Ein-Carem Medical Center

Jerusalem, IsraelOpen Hadassah Ein-Carem Medical Center in Google Maps

CompletedOne Study Center