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NCT Number: NCT05939518

Fluid Therapy and Glycocalyx Shedding During Moderate Surgery

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.

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Key information

Conditions

Abdominoplasty

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Ein-Carem Medical Center

Jerusalem, 9112001, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnancy.

Treatment and study plan

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.

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.

Other names: Recovery Room Fluid Management Protocol

Primary outcomes

  1. Change from preoperative serum concentration of Heparan Sulfate.

    Time frame: Two hours after completion of surgery.

    Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.

  2. Change from preoperative serum concentration of Syndecan-1.

    Time frame: Two hours after completion of surgery.

    Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.

  3. Change from preoperative serum concentration of Hyaluronic Acid.

    Time frame: Two hours after completion of surgery.

    Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.

  4. Change from preoperative serum concentration of Sphingosine-1-Phosphate.

    Time frame: Two hours after completion of surgery.

    Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.

  5. Appearance of B-lines on lung ultrasonography.

    Time frame: Two hours after completion of surgery.

    Bilateral ultrasonography of the study participant's lungs, performed by a physician using two views: posterior and lateral.

  6. Early appearance of peripheral pitting edema.

    Time frame: Two hours after completion of surgery.

    Bilateral physical examination of the study participant's wrists and ankles, performed by a physician.

  7. Late appearance of peripheral pitting edema.

    Time frame: During the first postoperative day.

    Bilateral physical examination of the study participant's wrists and ankles, performed by a physician.

  8. Postoperative Morbidity Survey (POMS) Score.

    Time frame: During the first postoperative day.

    Clinically evaluated by a physician for each study participant.

  9. Early change in the percentage of Total Body Water and Extracellular Water.

    Time frame: Immediately after completion of surgery.

    Measured by bioimpedance using a commercially available device connected to the study participant.

  10. Late change in the percentage of Total Body Water and Extracellular Water.

    Time frame: Two hours after completion of surgery.

    Measured by bioimpedance using a commercially available device connected to the study participant.

Secondary outcomes

  1. Change from preoperative body weight.

    Time frame: During the first postoperative day.

    Recorded while the study participant stands on an electronic scale.

  2. Volume of urine produced during the procedure.

    Time frame: 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.

  3. Change from preoperative Heart Rate.

    Time frame: Immediately after completion of surgery.

    Measured using a continuous electrocardiography monitor connected to the study participant.

  4. Change from preoperative Mean Arterial Blood Pressure.

    Time frame: 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.

  5. Early change from preoperative Cardiac Output.

    Time frame: Immediately after completion of surgery.

    Measured non-invasively using a commercially available device connected to the study participant.

  6. Late change from preoperative Cardiac Output.

    Time frame: Two hours after completion of surgery.

    Measured non-invasively using a commercially available device connected to the study participant.

  7. Early change from preoperative serum concentration of C-Reactive Protein.

    Time frame: Immediately after completion of surgery.

    Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.

  8. Late change from preoperative serum concentration of C-Reactive Protein.

    Time frame: Two hours after completion of surgery.

    Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.

  9. Early change from preoperative serum concentration of Lactate.

    Time frame: Immediately after completion of surgery.

    Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.

  10. Late change from preoperative serum concentration of Lactate.

    Time frame: Two hours after completion of surgery.

    Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.

  11. Change from preoperative serum concentration of Creatinine.

    Time frame: Immediately after completion of surgery.

    Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.

  12. Change from preoperative serum concentration of Hemoglobin.

    Time frame: Immediately after completion of surgery.

    Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Collaborators

  • Hebrew University of Jerusalem

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 11, 2023
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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