Fluid Therapy and Glycocalyx Shedding During Moderate Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Liberal Lactated Ringer Fluid Protocol with Ephedrine and Phenylephrine Boluses 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
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.
Other: 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.
Other Names:
|
| Active Comparator: Restrictive Lactated Ringer Fluid Protocol with Noradrenaline Infusion 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
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.
Other: 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Change from preoperative body weight. [During the first postoperative day.]
Recorded while the study participant stands on an electronic scale.
- 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.
- 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 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients scheduled for abdominoplasty.
-
American Society of Anesthesiologists Classification 1 or 2.
Exclusion Criteria:
- Pregnancy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hadassah Ein-Carem Medical Center | Jerusalem | Israel | 9112001 |
Sponsors and Collaborators
- Hadassah Medical Organization
- Hebrew University of Jerusalem
Investigators
- Principal Investigator: Galel Yakobi, MD, Hadassah Medical Organization
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0388-19-HMO
- 008932_2020-05-12_MOH