Fluid Therapy and Glycocalyx Shedding During Moderate Surgery

Abdominoplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05939518
• Other study ID #: 0388-19-HMO
• Secondary ID: 008932_2020-05-1
• Status: Recruiting
• Phase: N/A
• Start date: May 13, 2020
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2023
• Source: Hadassah Medical Organization
• Contact: Peter Davydov, MD
• Phone: +972-50-721-2550
• Email: petka88[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: June 1, 2024
• Est. primary completion date: May 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy.

Related Conditions & MeSH terms

• Abdominoplasty

Intervention

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.
• 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.

Locations

Country	Name	City	State
Israel	Hadassah Ein-Carem Medical Center	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Hebrew University of Jerusalem

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from preoperative serum concentration of Heparan Sulfate.	Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.	Two hours after completion of surgery.
Primary	Change from preoperative serum concentration of Syndecan-1.	Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.	Two hours after completion of surgery.
Primary	Change from preoperative serum concentration of Hyaluronic Acid.	Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.	Two hours after completion of surgery.
Primary	Change from preoperative serum concentration of Sphingosine-1-Phosphate.	Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.	Two hours after completion of surgery.
Primary	Appearance of B-lines on lung ultrasonography.	Bilateral ultrasonography of the study participant's lungs, performed by a physician using two views: posterior and lateral.	Two hours after completion of surgery.
Primary	Early appearance of peripheral pitting edema.	Bilateral physical examination of the study participant's wrists and ankles, performed by a physician.	Two hours after completion of surgery.
Primary	Late appearance of peripheral pitting edema.	Bilateral physical examination of the study participant's wrists and ankles, performed by a physician.	During the first postoperative day.
Primary	Postoperative Morbidity Survey (POMS) Score.	Clinically evaluated by a physician for each study participant.	During the first postoperative day.
Primary	Early change in the percentage of Total Body Water and Extracellular Water.	Measured by bioimpedance using a commercially available device connected to the study participant.	Immediately after completion of surgery.
Primary	Late change in the percentage of Total Body Water and Extracellular Water.	Measured by bioimpedance using a commercially available device connected to the study participant.	Two hours after completion of surgery.
Secondary	Change from preoperative body weight.	Recorded while the study participant stands on an electronic scale.	During the first postoperative day.
Secondary	Volume of urine produced during the procedure.	Measured using a volumetric graduated urine collection container connected to a Foley catheter placed in the urinary bladder of the study participant.	Immediately after completion of surgery.
Secondary	Change from preoperative Heart Rate.	Measured using a continuous electrocardiography monitor connected to the study participant.	Immediately after completion of surgery.
Secondary	Change from preoperative Mean Arterial Blood Pressure.	Measured using an automated oscillometric blood pressure monitoring device with its cuff placed on one of the arms of the study participant.	Immediately after completion of surgery.
Secondary	Early change from preoperative Cardiac Output.	Measured non-invasively using a commercially available device connected to the study participant.	Immediately after completion of surgery.
Secondary	Late change from preoperative Cardiac Output.	Measured non-invasively using a commercially available device connected to the study participant.	Two hours after completion of surgery.
Secondary	Early change from preoperative serum concentration of C-Reactive Protein.	Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.	Immediately after completion of surgery.
Secondary	Late change from preoperative serum concentration of C-Reactive Protein.	Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.	Two hours after completion of surgery.
Secondary	Early change from preoperative serum concentration of Lactate.	Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.	Immediately after completion of surgery.
Secondary	Late change from preoperative serum concentration of Lactate.	Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.	Two hours after completion of surgery.
Secondary	Change from preoperative serum concentration of Creatinine.	Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.	Immediately after completion of surgery.
Secondary	Change from preoperative serum concentration of Hemoglobin.	Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.	Immediately after completion of surgery.