Coronary Artery BypassPhase 4NCT00394303
Tight Intra-Operative Glucose Control During Coronary Artery Bypass Surgery
A Phase 4 study testing Intraoperative continuous insulin infusion in people with Coronary Artery Bypass, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Blood glucose levels increase in response to stress, infection or other conditions faced by patients in the hospital. This occurs commonly among patients with known diabetes, but also among non-diabetic hospitalized patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass
- What is being tested?
- Intraoperative continuous insulin infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2007to Aug 2009
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All consecutive patients >18 years undergoing CABG, without or without additional valve or other surgery at Rabin Medical Center; Beilinson campus, providing informed consent.
Who cannot join
- Patients with diabetic ketoacidosis, or hyperosmolar coma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tight Intra-Operative Glucose Control Using Continuous Insulin Infusion During Coronary Artery Bypass Surgery: Randomized Controlled Trial
Blood glucose levels increase in response to stress, infection or other conditions faced by patients in the hospital. This occurs commonly among patients with known diabetes, but also among non-diabetic hospitalized patients. Tight glucose control, the maintenance of blood glucose levels within normal limits (80-120 mg/dl), has been shown to improve patient outcomes in the hospital in several settings, mainly among critically ill patients hospitalized in intensive care units.
We plan to assess the importance of tight glucose control during open-heart surgery. The prevalence of hyperglycemia (elevated blood glucose) during this operation is high. Hyperglycemia may be associated with increased vulnerability to surgical site infections, neurological damage, cardiac and renal injury. Conversely, tight glucose control may be associated with hypoglycemia (pathologically low glucose levels) that may results in neurological injury. We hypothesize that tight glucose control will improve patient outcomes following surgery.
Read the detailed description
Current evidence supports intensive glucose control for patients in the intensive care unit post-cardiac surgery. The risk-benefit ratio of tight glucose control using continuous insulin infusion during surgery has not been established. Pros for tight control include the association of hyperglycemia with neurological injury, cardiac ischemia, white blood cell dysfunction and renal failure. The cons include adverse effects, mainly hypoglycemia and hypokalemia. As with any intervention in medicine, tight intra-operative glucose control should be assessed in a randomized controlled trial.
Objectives:to assess whether tight intra-operative tight glucose control using continuous insulin infusion reduces morbidity and mortality following cardiac surgery, defined as the incidence rate of surgical site infections, adverse neurological events, renal failure and 30-day mortality following CABG.
Additional outcomes will include the effect of continuous insulin infusion on longer-term mortality; other infectious complications and antibiotic use during hospitalization; cardiovascular outcomes; the need for re-operations; length of hospital stay; readmission; hypoglycemia and other adverse events.
Design: randomized controlled trial, with blinding of outcome assessors.
Participants: all consecutive patients >18 years undergoing CABG, without or without additional valve or other surgery at Rabin Medical Center; Beilinson campus, providing informed consent.
Exclusion criteria: patients with diabetic ketoacidosis, or hyperosmolar coma.
Intervention: Continuous insulin infusion throughout the operation aimed to maintain normoglycemia using a nomogram
Control: Glucose management according to the discretion of the anesthesiologist (continuous or bolus infusion)
During the early post-operative period (ICU-stay following surgery), all patients will be treated with intensive glucose control targeting glucose levels between 80-110.
- Conditions
- Coronary Artery Bypass
- Being tested
- Intraoperative continuous insulin infusion, Control
- Keywords
- Open heart surgery, Diabetes mellitus, Hyperglycemia, Surgical site infection, Normoglycemia
- Medical subject headings
- Diabetes Mellitus, Hyperglycemia, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative continuous insulin infusionDrug
Nomogram specified in appendix
ControlOther
Glucose management according to the discretion of the anesthesiologist aimed to maintain glucose levels <200 mg.dl, reflecting current practice.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intervention Receives: Drug: Intraoperative continuous insulin infusion |
| 2 | No intervention | Control Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day all-cause mortality.
Measured: 30-day
Deep or organ/ space (mediastinitis) surgical site infections.
Measured: 90 days
Acute renal failure during post-operative ICU stay, defined as: doubling of serum creatinine from baseline; or >50% reduction from baseline glomerular filtration rate; or need for renal replacement therapy.
Measured: 30 days
Perioperative cerebrovascular event defined as any new, temporary or permanent, focal or global neurological deficit.
Measured: 30 days
Secondary outcomes (12)
Individual components of the composite primary outcome
Measured: 30 days
6-months and long-term survival.
Measured: 6 ans 12 months
Other infectious complications during ICU stay including pneumonia and bloodstream infections according to CDC criteria
Measured: ICU stay
Antibiotic use
Measured: 30 days
Durations of intubation, ICU and hospital stay
Measured: hospital stay
Other post-operative complications occurring during ICU stay, including re-intubation, re-operation
Measured: ICU stay
Occurrence of hypoglycemia, defined as blood glucose level of 50mg/ dl or less, during surgery and up to the first glucose measurement in ICU.
Measured: during surgery
Occurrence of severe hypokalemia, defined as K<2.5 mEq/l, during surgery
Measured: during surgery
Glucose control in ICU, during the first 2 post-operative days
Measured: 2 post-operative days
Neurological status before surgery, at discharge and 3 months following surgery:
Measured: 3 months
Adverse cardiac events occurring during ICU stay
Measured: ICU stay
Re-hospitalizations
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2006 (estimated)
- Study startFeb 2007
- Study completionAug 2009 (estimated)
Why it stopped: Trial suspended on 26 February, following the publication of a trial with negative results (Ann Intern Med 146(4), 2007). Pending ethics committee re-approval.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery BypassStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Mical Paul, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394303
- Sponsor's protocol ID
- 4214
- Status last verified
- Jun 2007
- First submitted
- 31 Oct 2006
- Last updated
- 1 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tight Intra-Operative Glucose Control Using Continuous Insulin Infusion During Coronary Artery Bypass Surgery: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00394303
- Acronym / sponsor ID
- 4214
- Conditions
- Coronary Artery Bypass
- Keywords
- Open heart surgery, Diabetes mellitus, Hyperglycemia, Surgical site infection, Normoglycemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial suspended on 26 February, following the publication of a trial with negative results (Ann Intern Med 146(4), 2007). Pending ethics committee re-approval.
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Feb 2007
- Study completion
- Aug 2009 (estimated)
- First posted
- 1 Nov 2006 (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.
Blood glucose levels increase in response to stress, infection or other conditions faced by patients in the hospital. This occurs commonly among patients with known diabetes, but also among non-diabetic hospitalized patients. Tight glucose control, the maintenance of blood glucose levels within normal limits (80-120 mg/dl), has been shown to improve patient outcomes in the hospital in several settings, mainly among critically ill patients hospitalized in intensive care units.
We plan to assess the importance of tight glucose control during open-heart surgery. The prevalence of hyperglycemia (elevated blood glucose) during this operation is high. Hyperglycemia may be associated with increased vulnerability to surgical site infections, neurological damage, cardiac and renal injury. Conversely, tight glucose control may be associated with hypoglycemia (pathologically low glucose levels) that may results in neurological injury. We hypothesize that tight glucose control will improve patient outcomes following surgery.
Detailed description
Current evidence supports intensive glucose control for patients in the intensive care unit post-cardiac surgery. The risk-benefit ratio of tight glucose control using continuous insulin infusion during surgery has not been established. Pros for tight control include the association of hyperglycemia with neurological injury, cardiac ischemia, white blood cell dysfunction and renal failure. The cons include adverse effects, mainly hypoglycemia and hypokalemia. As with any intervention in medicine, tight intra-operative glucose control should be assessed in a randomized controlled trial.
Objectives:to assess whether tight intra-operative tight glucose control using continuous insulin infusion reduces morbidity and mortality following cardiac surgery, defined as the incidence rate of surgical site infections, adverse neurological events, renal failure and 30-day mortality following CABG.
Additional outcomes will include the effect of continuous insulin infusion on longer-term mortality; other infectious complications and antibiotic use during hospitalization; cardiovascular outcomes; the need for re-operations; length of hospital stay; readmission; hypoglycemia and other adverse events.
Design: randomized controlled trial, with blinding of outcome assessors.
Participants: all consecutive patients >18 years undergoing CABG, without or without additional valve or other surgery at Rabin Medical Center; Beilinson campus, providing informed consent.
Exclusion criteria: patients with diabetic ketoacidosis, or hyperosmolar coma.
Intervention: Continuous insulin infusion throughout the operation aimed to maintain normoglycemia using a nomogram
Control: Glucose management according to the discretion of the anesthesiologist (continuous or bolus infusion)
During the early post-operative period (ICU-stay following surgery), all patients will be treated with intensive glucose control targeting glucose levels between 80-110.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Intraoperative continuous insulin infusionIntervention |
| 2 | No intervention | Other: ControlControl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All consecutive patients >18 years undergoing CABG, without or without additional valve or other surgery at Rabin Medical Center; Beilinson campus, providing informed consent.
Key exclusion criteria (1 listed)
- Patients with diabetic ketoacidosis, or hyperosmolar coma
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 |
|---|---|---|
| Intraoperative continuous insulin infusionNomogram specified in appendix | Drug | 1 |
| ControlGlucose management according to the discretion of the anesthesiologist aimed to maintain glucose levels <200 mg.dl, reflecting current practice. | Other | 2 |
Primary outcome
30-day all-cause mortality.
Time frame: 30-day
Deep or organ/ space (mediastinitis) surgical site infections.
Time frame: 90 days
Acute renal failure during post-operative ICU stay, defined as: doubling of serum creatinine from baseline; or >50% reduction from baseline glomerular filtration rate; or need for renal replacement therapy.
Time frame: 30 days
Perioperative cerebrovascular event defined as any new, temporary or permanent, focal or global neurological deficit.
Time frame: 30 days
12 secondary outcomes
Individual components of the composite primary outcome
Time frame: 30 days
6-months and long-term survival.
Time frame: 6 ans 12 months
Other infectious complications during ICU stay including pneumonia and bloodstream infections according to CDC criteria
Time frame: ICU stay
Antibiotic use
Time frame: 30 days
Durations of intubation, ICU and hospital stay
Time frame: hospital stay
Other post-operative complications occurring during ICU stay, including re-intubation, re-operation
Time frame: ICU stay
Occurrence of hypoglycemia, defined as blood glucose level of 50mg/ dl or less, during surgery and up to the first glucose measurement in ICU.
Time frame: during surgery
Occurrence of severe hypokalemia, defined as K<2.5 mEq/l, during surgery
Time frame: during surgery
Glucose control in ICU, during the first 2 post-operative days
Time frame: 2 post-operative days
Neurological status before surgery, at discharge and 3 months following surgery:
Time frame: 3 months
Adverse cardiac events occurring during ICU stay
Time frame: ICU stay
Re-hospitalizations
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Trial suspended on 26 February, following the publication of a trial with negative results (Ann Intern Med 146(4), 2007). Pending ethics committee re-approval.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2009.
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Coronary Artery Bypass Graft (CABG)
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.
Mical Paul, MD principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intraoperative continuous insulin infusion in people with Coronary Artery Bypass, run by Rabin Medical Center at 1 site in Israel.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 1 Apr 2009. 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 Israel. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Trial suspended on 26 February, following the publication of a trial with negative results (Ann Intern Med 146(4), 2007). Pending ethics committee re-approval.). 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?
30-day all-cause mortality. (time frame: 30-day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2009.