Fluid Therapy and Glycocalyx Shedding During Moderate Surgery

Hadassah Medical Center

Status: Completed

Conditions: Abdominoplasty

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05939518

008932_2020-05-12_MOH (Registry Identifier)

0388-19-HMO

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Pregnancy.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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51 participants in 2 patient groups

Liberal Lactated Ringer Fluid Protocol with Ephedrine and Phenylephrine Boluses

Experimental group

Description:

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.

Treatment:

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 group

Description:

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.

Treatment:

Other: Lactated Ringer's Fluid Bolus Response to Low Urinary Output

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