Clinical trial NCT05939518: Fluid Therapy and Glycocalyx Shedding During Moderate Surgery
Official title: The Contribution of Liberal Fluid Therapy to Glycocalyx Shedding, Interstitial Edema and Fluid Accumulation During Moderate Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominoplasty
Keywords: Glycocalyx
IV Fluids
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Hebrew University of Jerusalem
First posted: 2023-07-11
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Pregnancy.

Primary outcomes:
measure: Change from preoperative serum concentration of Heparan Sulfate.
timeFrame: Two hours after completion of surgery.
measure: Change from preoperative serum concentration of Syndecan-1.
timeFrame: Two hours after completion of surgery.
measure: Change from preoperative serum concentration of Hyaluronic Acid.
timeFrame: Two hours after completion of surgery.
measure: Change from preoperative serum concentration of Sphingosine-1-Phosphate.
timeFrame: Two hours after completion of surgery.
measure: Appearance of B-lines on lung ultrasonography.
timeFrame: Two hours after completion of surgery.
measure: Early appearance of peripheral pitting edema.
timeFrame: Two hours after completion of surgery.
measure: Late appearance of peripheral pitting edema.
timeFrame: During the first postoperative day.
measure: Postoperative Morbidity Survey (POMS) Score.
timeFrame: During the first postoperative day.
measure: Early change in the percentage of Total Body Water and Extracellular Water.
timeFrame: Immediately after completion of surgery.
measure: Late change in the percentage of Total Body Water and Extracellular Water.
timeFrame: Two hours after completion of surgery.
Secondary outcomes:
measure: Change from preoperative body weight.
timeFrame: During the first postoperative day.
measure: Volume of urine produced during the procedure.
timeFrame: Immediately after completion of surgery.
measure: Change from preoperative Heart Rate.
timeFrame: Immediately after completion of surgery.
measure: Change from preoperative Mean Arterial Blood Pressure.
timeFrame: Immediately after completion of surgery.
measure: Early change from preoperative Cardiac Output.
timeFrame: Immediately after completion of surgery.
measure: Late change from preoperative Cardiac Output.
timeFrame: Two hours after completion of surgery.
measure: Early change from preoperative serum concentration of C-Reactive Protein.
timeFrame: Immediately after completion of surgery.
measure: Late change from preoperative serum concentration of C-Reactive Protein.
timeFrame: Two hours after completion of surgery.
measure: Early change from preoperative serum concentration of Lactate.
timeFrame: Immediately after completion of surgery.
measure: Late change from preoperative serum concentration of Lactate.
timeFrame: Two hours after completion of surgery.
measure: Change from preoperative serum concentration of Creatinine.
timeFrame: Immediately after completion of surgery.
measure: Change from preoperative serum concentration of Hemoglobin.
timeFrame: Immediately after completion of surgery.
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Ein-Carem Medical Center
Study officials:
affiliation: Hadassah Medical Organization
name: Galel Yakobi, MD
role: PRINCIPAL_INVESTIGATOR
References: