Effects of Fluid Therapy on Microcirculatory Reactivity

Not Applicable

• Conditions: Microcirculation; Fluid Therapy
• Interventions: Other: colloid therapy; Other: crystal therapy

• Registration Number: NCT04982016
• Lead Sponsor: Beijing Anzhen Hospital

Brief Summary

Through preoperative fluid therapy, to investigate whether it can alleviate the microcirculation dysfunction after induction of anesthesia, and reduce the incidence of perioperative fluid therapy-related complications, thereby accelerating rehabilitation.

Detailed Description

Patients undergoing minimally invasive coronary artery bypass graft surgery were randomly divided into crystal group, colloid group and control group. The preoperative fluid reactivity was evaluated according to the passive leg lifting test (PLR). When stroke volume increased (△SV)\>16%, the patients in the crystal (carbonate Ringer solution) and the colloid group (hydroxyethyl starch solution) were treated with volume therapy, while the control group was not treated with PLR test and volume therapy. Vascular occlusion test was used to observe the effect of anesthesia induction on tissue oxygen saturation recovery slope (RecStO2) after volume therapy, Goal-directed fluid therapy was used during operation, and the postoperative microcirculation function and the incidence of related complications were observed.

Study Timeline

• Study First Submitted: 2021-06-24
• Study First Submitted QC: 2021-07-19
• Study First Posted: 2021-07-29
• Status Verified: 2021-09
• Study Start: 2021-09
• Last Update Submitted: 2021-09-05
• Last Update Posted: 2021-09-08
• Primary Completion: 2022-02
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• Age ≥ 18 years old
• Plan to undergo elective minimally invasive coronary artery bypass grafting (left anterior descending branch);
• Sign informed consent

Exclusion Criteria

• Left ventricular ejection fraction <40%
• Diabetes
• Renal insufficiency (serum creatinine>177umol/L)
• Liver insufficiency (AST, ALT>3 times)
• Peripheral vascular disease
• Carotid artery stenosis (>60%) VOT test contraindications (arm deformity, burns, arteriovenous shunt)
• Use glucocorticoids, vasoactive drugs, inotropic drugs or intra-aortic balloon counterpulsation (IABP)
• Allergic to colloidal fluids

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colloidal group	colloid therapy	The fluid reactivity was determined by PLR test before anesthesia induction. The basic value was measured when maintain the head height at 45° for 2 min. and the liquid reactivity value was measured when both legs were raised 45° for 2 min. If △SV \>16%, restore the head height to 45°, and 250ml colloidal fluid was infused (infusion time \>10min).
Crystal group	crystal therapy	The fluid reactivity was determined by PLR test before anesthesia induction. The basic value was measured when maintain the head height at 45° for 2 min. and the liquid reactivity value was measured when both legs were raised 45° for 2 min. If △SV \>16%, restore the head height to 45°, and 250ml carbonated Ringer's solution was infused (infusion time \>10min).

Primary Outcome Measures

Name	Time	Method
Change in DesStO2 is assessed	The microcirculation function is measured at 4 time points: patients entered the operating room; 5 minutes after volume therapy; 30 minutes after anesthesia induction; and at the end of the operation	DesStO2(%/min):The downhill slope of StO2 reflects the oxygen consumption rate
Change in tM is assessed	The microcirculation function is measured at 4 time points: patients entered the operating room; 5 minutes after volume therapy; 30 minutes after anesthesia induction; and at the end of the operation	The time for minimum value of StO2 to recover to maximum value of StO2

Secondary Outcome Measures

Name	Time	Method
Change in HS is assessed	4 time points: patients entered the operating room; 5 minutes after volume therapy; 30 minutes after anesthesia induction; and at the end of the operation	HS(ng/ml): As a valuable clinical biomarker for glycocalyx degradation
Duration of stay in the intensive care unit	up to 60 days
Change in SDC-1 is assessed	4 time points: patients entered the operating room; 5 minutes after volume therapy; 30 minutes after anesthesia induction; and at the end of the operation	SDC-1(ng/ml): As a valuable clinical biomarker for glycocalyx degradation
Change in mean arterial pressure is assessed	4 time points: patients entered the operating room; 5 minutes after volume therapy; 30 minutes after anesthesia induction; and at the end of the operation
Change in heart rate is assessed	4 time points: patients entered the operating room; 5 minutes after volume therapy; 30 minutes after anesthesia induction; and at the end of the operation
Length of hospital stay	up to 60 days