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Cardiac SurgeryPhase 2NCT01516138

Benefits of GIK in Cardiac Surgery Patients

A Phase 2 study testing GIK in people with Cardiac Surgery and Cardiopulmonary Bypass, run by Xijing Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to evaluate the effects of modified glucose - insulin - potassium (GIK) therapy in cardiac surgery patients undergoing cardiopulmonary bypass (CPB). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Cardiac Surgery, Cardiopulmonary Bypass
What is being tested?
GIK
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
930 participants
Where
1 siteChina
Study dates
Feb 2012to Feb 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Between 18 and 70 years of age
  • Elective cardiac surgery with first time cardiopulmonary bypass
  • Left ventricular ejection fraction(LVEF) ≥ 30%
  • Informed agreement signed

Who cannot join

  • Previous cardiac surgery
  • Emergent surgery
  • Cardiac surgery without the use of cardiopulmonary bypass
  • Diabetes mellitus
  • Severe renal insufficiency
  • Severe respiratory insufficiency
Show all 12Show fewer
  • Serious preoperative illness (sepsis, active infection or active malignancy requiring treatment)
  • Pregnant woman or positive pregnancy test
  • History of drug abuse
  • Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion
  • Enrollment in another clinical study
  • Lack of informed consent

Trial locations and contacts

1 site in 1 country.

China1 site

  • Deparment of Cardiovascular surgery,Xijing Hospital, Fourth Military Medical University

    Xi'an, Shaanxi, 710032

Other trials in China

About this study

Official title: Myocardial Protection of Glucose - Insulin - Potassium in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass

The purpose of this study is to evaluate the effects of modified glucose - insulin - potassium (GIK) therapy in cardiac surgery patients undergoing cardiopulmonary bypass (CPB).

Read the detailed description

Cardiopulmonary bypass (CPB) is a necessary technique to maintain the circulation during cardiac surgery. But CPB itself is associated with a series of problems of organs, such as hyperglycemia induced by neuroendocrine stress. The research showed that hyperglycemia induced by stress would cause a worsened hospital outcome for patients undergoing cardiac surgery. Intraoperative and postoperative glucose control is beneficial for patients.

It has been for more than 40 year since the first application of glucose - insulin - potassium (GIK) in cardiac surgery but the clinical application of GIK shows controversial results. The beginning time of application and the ratio of glucose and insulin may be the key reasons for the controversy. In our pilot trial of 40 valve replacement cases, we found that perioperative treatment of GIK with an insulin-glucose ratio of 1:3 showed beneficial effects during heart surgery. Therefore, the investigators are planning to continue to test this modified GIK regimen for more heart surgery patients and determine whether GIK may have cardioprotective effects on patients undergoing CPB surgery.

Myocardial biopsies for biological mechanism analysis will be performed prior to CPB, 15 min after aortic cross clamp application and 15 min after reperfusion only in a small cohort. Myocardial biopsies will be snap frozen or fixed.

Being tested
GIK, Control
Keywords
Glucose-insulin-potassium, Cardiac surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GIKDrug

    Also called Glucose-insulin-potassium

    Intravenous solution was started at about 10 minutes before general anesthesia, running at a rate of 1 mL/kg/h for 12.5 hours.

  • ControlDrug

    Also called Balanced salt solution

    Intravenous solution was started at about 10 minutes before general anesthesia, running at a rate of 1 mL/kg/h for 12.5 hours.

Study groups in NCT01516138
Study groupRoleWhat they receive
GIKActive comparatorglucose-insulin-potassium (GIK) consists of 20% glucose (200 g/L), 66.7 U/L regular insulin and 80 mmol/L potassium chloride (KCl).
Receives: Drug: GIK
ControlPlacebo comparator6.12 g/L sodium acetate, 5.85 g/L sodium chloride, 0.3 g/L potassium chloride and 0.33 g/L calcium chloride
Receives: Drug: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants of the major adverse cardiac events

    The composite of major adverse cardiac events included acute myocardial infarction, cardiac arrest with successful resuscitation, low cardiac output syndrome, congestive heart failure, arrhythmia and all-cause death.

    Measured: Stay in hospital

Secondary outcomes (3)

  1. mortality

    Measured: until the study ends

  2. Length of stay in intensive care unit and hospital

    Length of stay in intensive care unit and hospital

    Measured: Stay in intensive care unit and hospital

  3. Number of patients of postoperative complications

    Postoperative complications included prolonged ventilation, the use of inotropes, sepsis/infection, renal complications, stroke and reoperation.

    Measured: Stay in hospital

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionMar 2013
  4. Study completionFeb 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
930 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01516138
Sponsor's protocol ID
XJcuiqin_2012
Status last verified
Jul 2014
First submitted
8 Jan 2012
Last updated
31 Oct 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Zhao K, Zhang Y, Li J, Cui Q, Zhao R, Chen W, Liu J, Zhao B, Wan Y, Ma XL, Yu S, Yi D, Gao F. Modified Glucose-Insulin-Potassium Regimen Provides Cardioprotection With Improved Tissue Perfusion in Patients Undergoing Cardiopulmonary Bypass Surgery. J Am Heart Assoc. 2020 Mar 17;9(6):e012376. doi: 10.1161/JAHA.119.012376. Epub 2020 Mar 10.

    PubMed 32151220

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GIK in people with Cardiac Surgery and Cardiopulmonary Bypass, run by Xijing Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants of the major adverse cardiac events (time frame: Stay in hospital). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01516138, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2014.

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