Trial · NCT00524472
Outcomes Study of Hyperinsulinemic Glucose Control in Cardiac Surgery
NCT00524472, Not applicable, Completed, The Cleveland Clinic; results first posted 2018-10-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Outcomes Study of Hyperinsulinemic Glucose Control in Cardiac Surgery. Trials, record NCT00524472. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00524472
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Outcomes Study of Hyperinsulinemic Glucose Control in Cardiac Surgery
- NCT number
- NCT00524472
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,439 participants, actual
- Lead sponsor
- The Cleveland Clinic
- Conditions
- Cardiac Surgery
- Interventions
- Hyperinsulinemic-normoglycemic clamp, insulin at the standard of care levels
- First posted
- 2007-09-03
- Last updated
- 2018-10-26
- Results first posted
- 2018-10-26
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Any Major Morbidity/30-day Mortality | within 30 days post surgery | 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. |
| Secondary | Post Operative Atrial Fibrillation | 15 - 30 days post operative | Evidence suggests that maintaining intra-operative normoglycemia during cardiac surgery while providing exogenous glucose and high-dose insulin may decrease post-operative morbidity or mortality. Using a randomized, controlled design, we propose to test the primary hypothesis that normalization of blood glucose using a hyperinsulinemic-normoglycemic clamp technique reduces the risk of a composite of serious adverse outcomes in patients undergoing cardiac surgery |
| Secondary | Duration of Hospitalization | starting post operative day one to discharge from hospital, on an average of 8 days | Days from date of surgery to hospital discharge |
| Secondary | Duration of Intensive Care Stay | ICU stay hours during hospital stay after surgery, on average of 25 hours | Hours from date of surgery to discharge from intensive care unit |
| Secondary | All-cause Mortality | one year post operative | All-cause mortality identified during one-year follow-up. |
| Secondary | a Composite of Minor Postoperative Complications | within 30 days after surgery | a composite of minor postoperative complications, which includes: a) prolonged mechanical ventilation, b) low cardiac index, c) acute kidney injury, d) prolonged hospitalization, and 3) all-cause hospital readmission within 30 days. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Any Major Morbidity/30-day Mortality | within 30 days post surgery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Post Operative Atrial Fibrillation | 15 - 30 days post operative | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of Hospitalization | starting post operative day one to discharge from hospital, on an average of 8 days | days | MEDIAN | |
| SECONDARY | Duration of Intensive Care Stay | ICU stay hours during hospital stay after surgery, on average of 25 hours | hours | MEDIAN | |
| SECONDARY | All-cause Mortality | one year post operative | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | a Composite of Minor Postoperative Complications | within 30 days after surgery | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Any Major Morbidity/30-day Mortality | Hyperinsulinemic-normoglycemic Clamp | 46 | Participants | ||
| Any Major Morbidity/30-day Mortality | Insulin at the Standard of Care Levels | 82 | Participants | ||
| Post Operative Atrial Fibrillation | Hyperinsulinemic-normoglycemic Clamp | 209 | Participants | ||
| Post Operative Atrial Fibrillation | Insulin at the Standard of Care Levels | 235 | Participants | ||
| Duration of Hospitalization | Hyperinsulinemic-normoglycemic Clamp | 8 | 95% Confidence Interval 6 to 12 | days | |
| Duration of Hospitalization | Insulin at the Standard of Care Levels | 8 | 95% Confidence Interval 6 to 12 | days | |
| Duration of Intensive Care Stay | Hyperinsulinemic-normoglycemic Clamp | 25 | 95% Confidence Interval 24.9 to 26.3 | hours | |
| Duration of Intensive Care Stay | Insulin at the Standard of Care Levels | 27 | 95% Confidence Interval 25.2 to 27.3 | hours | |
| All-cause Mortality | Hyperinsulinemic-normoglycemic Clamp | 32 | Participants | ||
| All-cause Mortality | Insulin at the Standard of Care Levels | 22 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Hyperinsulinemic-normoglycemic Clamp | 709 | |
| Overall Study | STARTED | Insulin at the Standard of Care Levels | 730 | |
| Overall Study | COMPLETED | Hyperinsulinemic-normoglycemic Clamp | 709 | |
| Overall Study | COMPLETED | Insulin at the Standard of Care Levels | 730 | |
| Overall Study | NOT COMPLETED | Hyperinsulinemic-normoglycemic Clamp | 0 | |
| Overall Study | NOT COMPLETED | Insulin at the Standard of Care Levels | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | sae | Surgical and medical procedures | Hyperinsulinemic-normoglycemic Clamp | 18 | 709 | 18 |
| serious | sae | Surgical and medical procedures | Insulin at the Standard of Care Levels | 27 | 730 | 27 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hyperinsulinemic-normoglycemic Clamp | 32 | 709 |
| Total, all-cause mortality | Insulin at the Standard of Care Levels | 22 | 730 |
| Total, other adverse events | Hyperinsulinemic-normoglycemic Clamp | 0 | 709 |
| Total, other adverse events | Insulin at the Standard of Care Levels | 0 | 730 |
| Total, serious adverse events | Hyperinsulinemic-normoglycemic Clamp | 18 | 709 |
| Total, serious adverse events | Insulin at the Standard of Care Levels | 27 | 730 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Hyperinsulinemic-normoglycemic Clamp vs Insulin at the Standard of Care Levels: Any Major Morbidity/30-day Mortality | Trial comparisons |
| Hyperinsulinemic-normoglycemic Clamp vs Insulin at the Standard of Care Levels: Post Operative Atrial Fibrillation | Trial comparisons |
| Hyperinsulinemic-normoglycemic Clamp vs Insulin at the Standard of Care Levels: All-cause Mortality | Trial comparisons |
| Hyperinsulinemic-normoglycemic Clamp vs Insulin at the Standard of Care Levels: a Composite of Minor Postoperative Complications | Trial comparisons |
| Hyperinsulinemic-normoglycemic Clamp vs Insulin at the Standard of Care Levels: deaths from any cause | Trial comparisons |
| Hyperinsulinemic-normoglycemic Clamp vs Insulin at the Standard of Care Levels: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00524472
GET https://conductscience.org/api/trials/v1/NCT00524472/registered