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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05939518

Enrollment

Registered

2023-07-11

Start date

2020-05-13

Completion date

2023-08-03

Last updated

2024-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominoplasty

Keywords

Glycocalyx, IV Fluids

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.

Interventions

OTHERLactated 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.

OTHERPost-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Pregnancy.

Design outcomes

Primary

Measure	Time frame	Description
Change from preoperative serum concentration of Heparan Sulfate.	Two hours after completion of surgery.	Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.
Change from preoperative serum concentration of Syndecan-1.	Two hours after completion of surgery.	Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.
Change from preoperative serum concentration of Hyaluronic Acid.	Two hours after completion of surgery.	Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.
Change from preoperative serum concentration of Sphingosine-1-Phosphate.	Two hours after completion of surgery.	Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.
Appearance of B-lines on lung ultrasonography.	Two hours after completion of surgery.	Bilateral ultrasonography of the study participant's lungs, performed by a physician using two views: posterior and lateral.
Early appearance of peripheral pitting edema.	Two hours after completion of surgery.	Bilateral physical examination of the study participant's wrists and ankles, performed by a physician.
Late appearance of peripheral pitting edema.	During the first postoperative day.	Bilateral physical examination of the study participant's wrists and ankles, performed by a physician.
Postoperative Morbidity Survey (POMS) Score.	During the first postoperative day.	Clinically evaluated by a physician for each study participant.
Early change in the percentage of Total Body Water and Extracellular Water.	Immediately after completion of surgery.	Measured by bioimpedance using a commercially available device connected to the study participant.
Late change in the percentage of Total Body Water and Extracellular Water.	Two hours after completion of surgery.	Measured by bioimpedance using a commercially available device connected to the study participant.

Secondary

Measure	Time frame	Description
Change from preoperative serum concentration of Creatinine.	Immediately after completion of surgery.	Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.
Change from preoperative body weight.	During the first postoperative day.	Recorded while the study participant stands on an electronic scale.
Change from preoperative serum concentration of Hemoglobin.	Immediately after completion of surgery.	Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.
Volume of urine produced during the procedure.	Immediately after completion of surgery.	Measured using a volumetric graduated urine collection container connected to a Foley catheter placed in the urinary bladder of the study participant.
Change from preoperative Heart Rate.	Immediately after completion of surgery.	Measured using a continuous electrocardiography monitor connected to the study participant.
Change from preoperative Mean Arterial Blood Pressure.	Immediately after completion of surgery.	Measured using an automated oscillometric blood pressure monitoring device with its cuff placed on one of the arms of the study participant.
Early change from preoperative Cardiac Output.	Immediately after completion of surgery.	Measured non-invasively using a commercially available device connected to the study participant.
Late change from preoperative Cardiac Output.	Two hours after completion of surgery.	Measured non-invasively using a commercially available device connected to the study participant.
Early change from preoperative serum concentration of C-Reactive Protein.	Immediately after completion of surgery.	Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.
Late change from preoperative serum concentration of C-Reactive Protein.	Two hours after completion of surgery.	Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.
Early change from preoperative serum concentration of Lactate.	Immediately after completion of surgery.	Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.
Late change from preoperative serum concentration of Lactate.	Two hours after completion of surgery.	Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026