Effects of Fluid Therapy on Microcirculatory Reactivity

Effects of Preoperative Fluid Therapy on Microcirculatory Reactivity in Patients With MIDCAB After General Anesthesia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fluid Therapy; Microcirculation
• Intervention / Treatment: Other: crystal therapy; Other: colloid therapy

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 Type: Interventional
• Enrollment (Anticipated): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Boqun Cui, Doctor; Phone Number: 13811868848; Email: 120053376@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; There is no treatment before anesthesia induction.
Experimental: Crystal group; 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).	Other: crystal therapy; Infusion of 250ml crystal solution before anesthesia induction
Experimental: Colloidal group; 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).	Other: colloid therapy; Infusion of 250ml colloid solution before anesthesia induction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in DesStO2 is assessed	DesStO2(%/min):The downhill slope of StO2 reflects the oxygen consumption rate	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
Change in tM is assessed	The time for minimum value of StO2 to recover to maximum value of StO2	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Duration of stay in the intensive care unit		up to 60 days
Change in HS is assessed	HS(ng/ml): As a valuable clinical biomarker for glycocalyx degradation	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 SDC-1 is assessed	SDC-1(ng/ml): As a valuable clinical biomarker for glycocalyx degradation	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

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital
• Investigators: Principal Investigator: Boqun Cui, Doctor, Anzhen hospital Beijing China

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: July 19, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 5, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: microcirculation; minimally invasive coronary artery bypass grafting; fuid therapy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Sympathomimetics; Adrenergic Uptake Inhibitors; Methamphetamine
• Other Study ID Numbers: 2020093X

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No