Ignite Creation Date:
2024-05-05 @ 10:39 PM
Last Modification Date:
2024-10-26 @ 10:21 AM
Study NCT ID:
NCT01151176
Status:
SUSPENDED
Last Update Posted:
2012-06-19
First Post:
2010-03-04
Brief Title:
Feasible Insulin Algorithm for Glycemic Control in Patients With Acute Coronary Syndrome
Sponsor:
Universidade Positivo
Organization:
Universidade Positivo
Study Overview
Official Title:
Phase IV Study of a Feasible Insulin Algorithm for Glycemic Control in Patients With Acute Coronary Syndrome
Status:
SUSPENDED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administrative problems makes changes in hospital staff New clinical research team will restart
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study aims to demonstrate that a simple intravenous insulin algorithm can be implemented in Latin America and will result in safe and better glucose control in patients with Acute Coronary Syndrome ACS compared with SC insulin
Detailed Description:
The proposed study is a one center open-label randomized controlled clinical trialCoronary Intensive Care of one hospital in the city of Curitiba PR Brazil will be assessed
Consenting eligible subjects will be randomized to either the intensive insulin infusion therapy group ITG or the conventional therapy group CTG
This particular insulin infusion was adapted of a protocol has been used before in patients who underwent to cardiothoracic surgery and its efficacy has been reported in the literature
The control group will be selected following the same set of inclusion and exclusion criteria Patients will be randomized to receive SC regular insulin 4 times daily before meals and bedtime or every 6 hours if they are NPO
Data will be collected for history of diabetes heart disease hypertension hyperlipidemia Current smoker Cardiac treatment Aspirin Beta Blockers ACE inhibitorA2RB Nitrates Statin Fibrate Diabetes treatmentInsulin Metformin Sulphonylureas Data will be collect for Baseline BGL A1C level Troponin CPK CKP-Mb K Creatinine Classify Infarct type Anterioranteroseptal Inferior Non-ST-segment elevation myocardial infarction Not classified Cardiac intervention PTCA ThrombolysisNo reperfusion Heparin or low-molecular weight heparin
Subjects allocated to ITG will be placed on Grady Health System protocol and those in CTG will follow the sliding scale nomograms Insulin replacement will start during first 24h of admission Patients will be followed during all hospital stay but only at ICU the CIII and SC insulin replacement will be compared After ICU discharge they will follow they will be followed by their physician with recommendations to keep blod glucose180mgdL
Patients will be followed up to 90 days after hospital discharge with phone callSubjects will be contacted to obtain information regarding the occurrence of cardiovascular events following discharge If the subject is not contactable the next of kin andor the subjects general practitioner would be contacted Where no information could be obtained a request will be made to the Department of Births and Deaths
Consenting eligible subjects will be randomized to either the intensive insulin infusion therapy group ITG or the conventional therapy group CTG
This particular insulin infusion was adapted of a protocol has been used before in patients who underwent to cardiothoracic surgery and its efficacy has been reported in the literature
The control group will be selected following the same set of inclusion and exclusion criteria Patients will be randomized to receive SC regular insulin 4 times daily before meals and bedtime or every 6 hours if they are NPO
Data will be collected for history of diabetes heart disease hypertension hyperlipidemia Current smoker Cardiac treatment Aspirin Beta Blockers ACE inhibitorA2RB Nitrates Statin Fibrate Diabetes treatmentInsulin Metformin Sulphonylureas Data will be collect for Baseline BGL A1C level Troponin CPK CKP-Mb K Creatinine Classify Infarct type Anterioranteroseptal Inferior Non-ST-segment elevation myocardial infarction Not classified Cardiac intervention PTCA ThrombolysisNo reperfusion Heparin or low-molecular weight heparin
Subjects allocated to ITG will be placed on Grady Health System protocol and those in CTG will follow the sliding scale nomograms Insulin replacement will start during first 24h of admission Patients will be followed during all hospital stay but only at ICU the CIII and SC insulin replacement will be compared After ICU discharge they will follow they will be followed by their physician with recommendations to keep blod glucose180mgdL
Patients will be followed up to 90 days after hospital discharge with phone callSubjects will be contacted to obtain information regarding the occurrence of cardiovascular events following discharge If the subject is not contactable the next of kin andor the subjects general practitioner would be contacted Where no information could be obtained a request will be made to the Department of Births and Deaths
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None