Effects of Fluid Therapy on Microcirculatory Reactivity

NCT04982016 | Unknown

• 1 other identifier: 2020093X
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Microcirculation; Fluid Therapy

Keywords

minimally invasive coronary artery bypass grafting; fuid therapy; microcirculation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

  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

Study Arms (3)

Control group

NO INTERVENTION

There is no treatment before anesthesia induction.

Crystal group

EXPERIMENTAL

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

Colloidal group

EXPERIMENTAL

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

Interventions

crystal therapy OTHER

Infusion of 250ml crystal solution before anesthesia induction

Crystal group

colloid therapy OTHER

Infusion of 250ml colloid solution before anesthesia induction

Colloidal group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Officials

• Boqun Cui, Doctor

  Anzhen hospital Beijing China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Boqun Cui, Doctor

CONTACT

13811868848; 120053376@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief physician

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 29, 2021
• Study Start: September 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: April 1, 2022
• Last Updated: September 8, 2021

Record last verified: 2021-09