Effects of Fluid Therapy on Microcirculatory Reactivity

Sponsor
Beijing Anzhen Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04982016
Collaborator
(none)
126
3
7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: crystal therapy
  • Other: colloid therapy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
126 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
Effects of Preoperative Fluid Therapy on Microcirculatory Reactivity in Patients With MIDCAB After General Anesthesia
Anticipated Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  1. 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]

  2. 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]

  3. Length of hospital stay [up to 60 days]

  4. Duration of stay in the intensive care unit [up to 60 days]

  5. 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

  6. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Beijing Anzhen Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Boqun Cui, Deputy chief physician, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier:
NCT04982016
Other Study ID Numbers:
  • 2020093X
First Posted:
Jul 29, 2021
Last Update Posted:
Sep 8, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Boqun Cui, Deputy chief physician, Beijing Anzhen Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 8, 2021