Outcomes Study of Hyperinsulinemic Glucose Control in Cardiac Surgery

NCT00524472 | Completed Results DMC

• 1 other identifier: 07-470
• Study Type: interventional
• Target: 1,439
• Locations: 2 countries
• Sites: 2

Brief Summary

Patients undergoing cardiac surgery will be randomized into one of two groups. Group A will be administered insulin using the hyperinsulinemic-normoglycemic clamp to normalize blood glucose levels intra-operatively. Group B will be administered insulin at the standard of care levels established by the participating institution. Patients will be followed at 10 days, 15 days and one year post-operatively.

Conditions

Cardiac Surgery

Keywords

Hyperinsulinemic glucose control; cardiac surgery; Outcome

Outcome Measures

Primary Outcomes (1)

• Any Major Morbidity/30-day Mortality

  a composite (any versus none) of the following major postoperative complications occurring: 1. all-cause postoperative mortality 2. failure to wean from cardiopulmonary bypass or postoperative low cardiac index requiring mechanical circulatory support with intraaortic balloon counterpulsation, ventricular assist device, and/or extracorporeal mechanical oxygenation 3. serious postoperative infection 4. acute postoperative kidney injury requiring renal replacement therapy; 5. new postoperative focal or global neurologic deficit.

  within 30 days post surgery

Secondary Outcomes (5)

• Post Operative Atrial Fibrillation

  15 - 30 days post operative

• Duration of Hospitalization

  starting post operative day one to discharge from hospital, on an average of 8 days

• Duration of Intensive Care Stay

  ICU stay hours during hospital stay after surgery, on average of 25 hours

• All-cause Mortality

  one year post operative

• a Composite of Minor Postoperative Complications

  within 30 days after surgery

Study Arms (2)

Hyperinsulinemic-normoglycemic clamp

EXPERIMENTAL

Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL.

Other: Hyperinsulinemic-normoglycemic clamp

Insulin at the standard of care levels

OTHER

Group B will be administered insulin at the standard of care levels established by the participating institution.

Other: insulin at the standard of care levels

Interventions

Hyperinsulinemic-normoglycemic clamp OTHER

Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL.

Also known as: clamp, Hyperinsulinemic

Hyperinsulinemic-normoglycemic clamp

insulin at the standard of care levels OTHER

Subjects will be administered insulin at the standard of care levels established by the participating institution.

Also known as: insulin

Insulin at the standard of care levels

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-90 years old
• Scheduled for cardiac surgery requiring cardiopulmonary bypass

You may not qualify if:

• Off-pump surgical procedures
• Anticipated deep hypothermic circulatory arrest
• In available, baseline cardiac troponin I (\>0.5 ng/L) or troponin T (\> 0.1 ng/mL) levels (at RVH or CC, respectively)
• Any contraindications to the proposed interventions
• Active infection, including patients with endocarditis or infected pacemaker leads.
• Any infection requiring long- term antibiotics ( \> 14 days)
• kidney disease requiring renal replacement therapy

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (2)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

Related Publications (4)

• Albacker TB, Carvalho G, Schricker T, Lachapelle K. Myocardial protection during elective coronary artery bypass grafting using high-dose insulin therapy. Ann Thorac Surg. 2007 Dec;84(6):1920-7; discussion 1920-7. doi: 10.1016/j.athoracsur.2007.07.001.

  PMID: 18036907 RESULT

• Duncan AE, Kateby Kashy B, Sarwar S, Singh A, Stenina-Adognravi O, Christoffersen S, Alfirevic A, Sale S, Yang D, Thomas JD, Gillinov M, Sessler DI. Hyperinsulinemic Normoglycemia Does Not Meaningfully Improve Myocardial Performance during Cardiac Surgery: A Randomized Trial. Anesthesiology. 2015 Aug;123(2):272-87. doi: 10.1097/ALN.0000000000000723.

  PMID: 26200180 RESULT

• 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.

  PMID: 37526194 DERIVED

• Schricker T, Sato H, Beaudry T, Codere T, Hatzakorzian R, Pruessner JC. Intraoperative maintenance of normoglycemia with insulin and glucose preserves verbal learning after cardiac surgery. PLoS One. 2014 Jun 18;9(6):e99661. doi: 10.1371/journal.pone.0099661. eCollection 2014.

  PMID: 24941010 DERIVED

MeSH Terms

Interventions

Constriction; Insulin

Intervention Hierarchy (Ancestors)

Investigative Techniques; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Andra Duncan, MD
• Organization: Cleveland Clinic

DUNCANA@ccf.org

216 445-2372

Study Officials

• Andra I Duncan, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Daniel I Sessler, M.D.

  The Cleveland Clinic

  STUDY DIRECTOR

• Thomas Schricker, MD

  Royal Victoria Hospital, Montreal, Canada

  PRINCIPAL INVESTIGATOR

• George Carvalho, MD

  Royal Victoria Hospital, Montreal, Canada

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2007
• First Posted: September 3, 2007
• Study Start: July 1, 2007
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: October 26, 2018
• Results First Posted: October 26, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (1)