Aortic StenosisNCT00788242
The Effect of Glucose-Insulin-Potassium Infusion in Patients Undergoing Cardiac Surgery
A study testing Glucose-insulin-potassium in people with Aortic Stenosis and Coronary Heart Disease, run by Christoph Ellenberger at 2 sites in Switzerland.
Trial summary
The purpose of this study is to evaluate the cardioprotective effects of a short term infusion of glucose-insulin-potassium (GIK) during heart surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Aortic Stenosis, Coronary Heart Disease, Heart Failure
- What is being tested?
- Glucose-insulin-potassium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Jan 2009to Dec 2013
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe aortic stenosis
- Coronary artery disease associated with poor left ventricular function
- Parsonnet score >7
Who cannot join
- Dementia or inability to understand the study protocol
- Off-pump and emergent cardiac surgery
- Poorly controlled diabetes mellitus
- Severe renal insufficiency
- Abnormal liver function Child-Plugh - C
- Body Mass Index < 18 and > 35
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Geneva University Hospital
Geneva, Canton of Geneva, 1211
Cardiocentro
Lugano, Canton Ticino, 6900
About this study
Official title: The Effect of Glucose-Insulin-Potassium Infusion on Myocardial Injuries and Cardiac Function in Patients Undergoing Cardiac Surgery
The purpose of this study is to evaluate the cardioprotective effects of a short term infusion of glucose-insulin-potassium (GIK) during heart surgery.
Read the detailed description
Cardiac surgery with cardiopulmonary bypass and ischemic cardiac arrest is associated with a wide spectrum of perioperative myocardial ischemic-reperfusion injuries resulting in significant cardiac morbidity, namely contractile dysfunction, myocardial infarction, and low cardiac output syndrome requiring prolonged intensive care and hospital stay. The infusion of glucose-insulin-potassium (GIK) is one of the oldest cardioprotective interventions during cardiac surgery. Although experimental evidence is strong, clinical data remain conflicting. We will investigate the impact of short term GIK on the extent of myocardial injuries as well as on the left-ventricular systolic and diastolic function in 2 high-risk groups of cardiac surgical patients: Patients with cardiac dysfunction undergoing aortocoronary bypass surgery and patients with severe aortic stenosis.
- Conditions
- Aortic Stenosis, Coronary Heart Disease, Heart Failure
- Being tested
- Glucose-insulin-potassium, Placebo
- Keywords
- Cardiac surgery, Cardioprotection, Aortocoronary bypass graft, Aortic stenosis
- Medical subject headings
- Aortic Valve Stenosis, Coronary Disease, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose-insulin-potassiumDrug
20 IU of insulin and 10 mM of KCl mixed with 50 ml of 40% Glucose. Administration of 0.8 ml/kg/h over 60 min before aortic cross-clamping
PlaceboDrug
60 ml of isotonic saline. Administration of 0.8 ml/kg/h over 60 min before aortic cross-clamping
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Administration of glucose-insulin-potassium Receives: Drug: Glucose-insulin-potassium |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postcardiotomy ventricular dysfunction
Measured: 48h postoperative
Secondary outcomes (4)
Systolic and diastolic cardiac function using transoesophageal echocardiography
Measured: intraoperative
Hypo-/hyperglycemia Hypo-/hyperkaliemia
Measured: intraoperative
Serious cardiovascular adverse events (myocardial infarction, cardiac arrhythmia, low cardiac output, stroke)
Measured: 48 postoperative
Serum troponin and creatinine kinase
Measured: Intraoperative - 48 h postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christoph Ellenberger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christoph Ellenberger, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788242
- Sponsor's protocol ID
- NAC 08-032
- Status last verified
- Nov 2016
- First submitted
- 7 Nov 2008
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3.
PubMed 37526194Licker M, Diaper J, Sologashvili T, Ellenberger C. Glucose-insulin-potassium improves left ventricular performances after aortic valve replacement: a secondary analysis of a randomized controlled trial. BMC Anesthesiol. 2019 Sep 6;19(1):175. doi: 10.1186/s12871-019-0845-0.
PubMed 31492103
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Glucose-Insulin-Potassium Infusion on Myocardial Injuries and Cardiac Function in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00788242
- Acronym / sponsor ID
- NAC 08-032
- Conditions
- Aortic Stenosis, Coronary Heart Disease, Heart Failure
- Keywords
- Cardiac surgery, Cardioprotection, Aortocoronary bypass graft, Aortic stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Christoph EllenbergerUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 10 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the cardioprotective effects of a short term infusion of glucose-insulin-potassium (GIK) during heart surgery.
Detailed description
Cardiac surgery with cardiopulmonary bypass and ischemic cardiac arrest is associated with a wide spectrum of perioperative myocardial ischemic-reperfusion injuries resulting in significant cardiac morbidity, namely contractile dysfunction, myocardial infarction, and low cardiac output syndrome requiring prolonged intensive care and hospital stay. The infusion of glucose-insulin-potassium (GIK) is one of the oldest cardioprotective interventions during cardiac surgery. Although experimental evidence is strong, clinical data remain conflicting. We will investigate the impact of short term GIK on the extent of myocardial injuries as well as on the left-ventricular systolic and diastolic function in 2 high-risk groups of cardiac surgical patients: Patients with cardiac dysfunction undergoing aortocoronary bypass surgery and patients with severe aortic stenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Glucose-insulin-potassiumAdministration of glucose-insulin-potassium |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Severe aortic stenosis
- Coronary artery disease associated with poor left ventricular function
- Parsonnet score >7
Key exclusion criteria (6 listed)
- Dementia or inability to understand the study protocol
- Off-pump and emergent cardiac surgery
- Poorly controlled diabetes mellitus
- Severe renal insufficiency
- Abnormal liver function Child-Plugh - C
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose-insulin-potassium20 IU of insulin and 10 mM of KCl mixed with 50 ml of 40% Glucose. Administration of 0.8 ml/kg/h over 60 min before aortic cross-clamping | Drug | 1 |
| Placebo60 ml of isotonic saline. Administration of 0.8 ml/kg/h over 60 min before aortic cross-clamping | Drug | 2 |
Primary outcome
Postcardiotomy ventricular dysfunction
Time frame: 48h postoperative
4 secondary outcomes
Systolic and diastolic cardiac function using transoesophageal echocardiography
Time frame: intraoperative
Hypo-/hyperglycemia Hypo-/hyperkaliemia
Time frame: intraoperative
Serious cardiovascular adverse events (myocardial infarction, cardiac arrhythmia, low cardiac output, stroke)
Time frame: 48 postoperative
Serum troponin and creatinine kinase
Time frame: Intraoperative - 48 h postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2016.
- Derived from this study: PubMed 37526194Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3.
- Derived from this study: PubMed 31492103Licker M, Diaper J, Sologashvili T, Ellenberger C. Glucose-insulin-potassium improves left ventricular performances after aortic valve replacement: a secondary analysis of a randomized controlled trial. BMC Anesthesiol. 2019 Sep 6;19(1):175. doi: 10.1186/s12871-019-0845-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose-insulin-potassium in people with Aortic Stenosis and Coronary Heart Disease, run by Christoph Ellenberger at 2 sites in Switzerland.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postcardiotomy ventricular dysfunction (time frame: 48h postoperative). 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 NCT00788242, which also lists 2 linked publications.
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 23 Nov 2016.