Fluid Therapy and Glycocalyx Shedding During Moderate Surgery

NCT05939518 | Completed

• 2 other identifiers: 0388-19-HMO008932_2020-05-12_MOH
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (10)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• Postoperative Morbidity Survey (POMS) Score.

  Clinically evaluated by a physician for each study participant.

  During the first postoperative day.

• 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.

• 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 Outcomes (12)

• Change from preoperative body weight.

  During the first postoperative day.

• Volume of urine produced during the procedure.

  Immediately after completion of surgery.

• Change from preoperative Heart Rate.

  Immediately after completion of surgery.

• Change from preoperative Mean Arterial Blood Pressure.

  Immediately after completion of surgery.

• Early change from preoperative Cardiac Output.

  Immediately after completion of surgery.

Study Arms (2)

Liberal Lactated Ringer Fluid Protocol with Ephedrine and Phenylephrine Boluses

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.

Other: Lactated Ringer's Fluid Bolus Response to Low Urinary Output; Other: Post-Anesthesia Care Unit Lactated Ringer's Fluid Management Protocol

Restrictive Lactated Ringer Fluid Protocol with Noradrenaline Infusion

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.

Other: Lactated Ringer's Fluid Bolus Response to Low Urinary Output; Other: Post-Anesthesia Care Unit Lactated Ringer's Fluid Management Protocol

Interventions

Lactated Ringer's Fluid Bolus Response to Low Urinary Output 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.

Liberal Lactated Ringer Fluid Protocol with Ephedrine and Phenylephrine Boluses; Restrictive Lactated Ringer Fluid Protocol with Noradrenaline Infusion

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

Also known as: Recovery Room Fluid Management Protocol

Liberal Lactated Ringer Fluid Protocol with Ephedrine and Phenylephrine Boluses; Restrictive Lactated Ringer Fluid Protocol with Noradrenaline Infusion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy.

Sponsors & Collaborators

• Hadassah Medical Organization: lead
• Hebrew University of Jerusalem: collaborator

Study Sites (1)

Hadassah Ein-Carem Medical Center

Jerusalem, 9112001, Israel

Location

Study Officials

• Galel Yakobi, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: July 11, 2023
• Study Start: May 13, 2020
• Primary Completion: August 3, 2023
• Study Completion: August 3, 2023
• Last Updated: December 18, 2024

Record last verified: 2024-12

Locations

IL (1)