Effects of Fluid Therapy on Microcirculatory Reactivity

NCT ID: NCT04982016

Last Updated: 2021-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-30

Study Completion Date

2022-04-30

Brief Summary

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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

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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.

Conditions

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Microcirculation Fluid Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Control group

There is no treatment before anesthesia induction.

Group Type NO_INTERVENTION

No interventions assigned to this group

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).

Group Type EXPERIMENTAL

crystal therapy

Intervention Type OTHER

Infusion of 250ml crystal solution before anesthesia induction

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).

Group Type EXPERIMENTAL

colloid therapy

Intervention Type OTHER

Infusion of 250ml colloid solution before anesthesia induction

Interventions

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crystal therapy

Infusion of 250ml crystal solution before anesthesia induction

Intervention Type OTHER

colloid therapy

Infusion of 250ml colloid solution before anesthesia induction

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Anzhen Hospital

OTHER

Sponsor Role lead

Responsible Party

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Boqun Cui

Deputy chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Boqun Cui, Doctor

Role: PRINCIPAL_INVESTIGATOR

Anzhen hospital Beijing China

Central Contacts

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Boqun Cui, Doctor

Role: CONTACT

13811868848

Other Identifiers

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2020093X

Identifier Type: -

Identifier Source: org_study_id

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