Effects of Fluid Therapy on Microcirculatory Reactivity

Microcirculation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04982016
• Other study ID #: 2020093X
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2021
• Est. completion date: April 2022

Study information

• Verified date: September 2021
• Source: Beijing Anzhen Hospital
• Contact: Boqun Cui, Doctor
• Phone: 13811868848
• Email: 120053376[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 126
• Est. completion date: April 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fluid Therapy
• Microcirculation

Intervention

Other:
• crystal therapy
Infusion of 250ml crystal solution before anesthesia induction
• colloid therapy
Infusion of 250ml colloid solution before anesthesia induction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Length of hospital stay		up to 60 days
Secondary	Duration of stay in the intensive care unit		up to 60 days
Secondary	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
Secondary	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