NCT05464966

Brief Summary

The primary objective of this clinical trial was to investigate the effects of insulin on myocardial blood flow reflected by CSBF which was evaluated by TEE. The second aim was to observe the effect of insulin on cardiac function and markers of myocardial damage.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 19, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

January 19, 2024

Status Verified

January 1, 2024

Enrollment Period

12 months

First QC Date

May 15, 2022

Last Update Submit

January 18, 2024

Conditions

Insulin

Keywords

InsulinPerioperative periodBlood glucoseHeart protection

Outcome Measures

Primary Outcomes (2)

  • Changes in the coronary sinus blood flow spectrum

    coronary sinus blood flow spectrum changes such as SVTI、DVTI、AVTI are assessed by TEE

    from 30 minutes after intubation to 1 hour after intubation , from 30minutes before the end of the surgery to the end of the surgery

  • Changes in left ventricular diastolic function

    Changes in left ventricular diastolic function are assessed by TEE, such as changes in pulmonary venous blood flow

    from 30 minutes after intubation to 1 hour after intubation , from 30minutes before the end of the surgery to the end of the surgery

Secondary Outcomes (6)

  • Changes in the level of Systolic Blood Pressure/Diastolic Blood Pressure(Mean Arterial Pressure)

    into ICU 30 minutes

  • Changes in the level of Cardiac output

    into ICU 30 minutes

  • Changes in the level of Heart Rate

    into ICU 30 minutes

  • Changes in the level of SVR

    into ICU 30 minutes

  • Changes in the level of SVRI

    into ICU 30 minutes

  • +1 more secondary outcomes

Study Arms (2)

Glucose-insulin-potassium

EXPERIMENTAL
Drug: Glucose insulin potassium

Control

NO INTERVENTION

Interventions

Glucose insulin potassiumDRUG

After induction of anaesthesia,cardiac systolic-diastolic function was first measured by TEE, GIK solution was continuously pumped until the end of the procedure at a dose of 30 mU/kg/h of insulin, 0.12 g/kg/h of glucose and 0.06 mmol/kg/h of potassium chloride

Glucose-insulin-potassium

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 55-80 years, ASA grade II-III, regardless of gender,
  • BMI 18.5-28.0 kg/m2,
  • scheduled for elective coronary artery bypass grafting (CABG), valve repair or replacement, or a combination of these procedures with cardiopulmonary bypass.

You may not qualify if:

  • non-first cardiac surgery;
  • emergency cardiac surgery;
  • severe heart failure with preoperative left ventricular ejection fraction \<30%;
  • contraindication to TEE;
  • kidney disease requiring replacement therapy;
  • combined with multi-organ insufficiency;
  • Severe infection requiring continuous antibiotic treatment;
  • use of large doses of hormone or nonsteroidal anti-inflammatory drugs within the last 2 weeks.
  • after the patient entered the operating room, if the first blood glucose exceeded 180 mg/dl, a second test was performed 15 minutes later, and if the average of the two blood glucoses exceeded 180 mg/dl, the patient was excluded as well.
  • Elimination criteria included
  • unplanned secondary CPB;
  • need for intra-aortic balloon pump technical support during the study period;
  • TEE image acquired with poor quality.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, China

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

glucose-insulin-potassium cardioplegic solution

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 15, 2022

First Posted

July 19, 2022

Study Start

June 1, 2022

Primary Completion

May 31, 2023

Study Completion

June 30, 2023

Last Updated

January 19, 2024

Record last verified: 2024-01

Locations

CN(1)