N/A
N=1,439
Outcomes Study of Hyperinsulinemic Glucose Control in Cardiac Surgery
Cardiac Surgery
Bottom Line
View on ClinicalTrials.gov: NCT00524472 ↗Enrolled (actual)
1,439
Serious AEs
3.1%
Results posted
Oct 2018
Primary outcome: Primary: Any Major Morbidity/30-day Mortality — 46; 82 Participants — p=0.0043
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hyperinsulinemic-normoglycemic clamp (Other); insulin at the standard of care levels (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Any Major Morbidity/30-day Mortality |
46; 82 | 0.0043 sig |
| SECONDARY Post Operative Atrial Fibrillation |
209; 235 | 0.29 |
| SECONDARY Duration of Hospitalization |
8; 8 | 0.99 |
| SECONDARY Duration of Intensive Care Stay |
25; 27 | 0.025 sig |
| SECONDARY All-cause Mortality |
32; 22 | 0.12 |
| SECONDARY a Composite of Minor Postoperative Complications |
200; 237 | 0.085 |
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.
Eligibility Criteria
Inclusion Criteria
- Age 18-90 years old
- Scheduled for cardiac surgery requiring cardiopulmonary bypass
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00524472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.