Acute Coronary Syndrome
Conditions
Keywords
Intensive Insulin Therapy, Glucose control, Acute Coronary Syndrome, Intensive Care
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 trial.Coronary 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 inhibitor/A2RB, Nitrates, Statin, Fibrate) Diabetes treatment(Insulin, Metformin, Sulphonylureas) Data will be collect for Baseline BGL , A1C level, Troponin, CPK, CKP-Mb, K, Creatinine. Classify Infarct type : Anterior/anteroseptal, Inferior, Non-ST-segment elevation myocardial infarction, Not classified Cardiac intervention : PTCA , Thrombolysis,No 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 glucose\<180mg/dL. Patients will be followed up to 90 days after hospital discharge with phone call.Subjects will be contacted to obtain information regarding the occurrence of cardiovascular events following discharge. If the subject is not contactable, the next of kin and/or the subject's general practitioner would be contacted. Where no information could be obtained, a request will be made to the Department of Births and Deaths.
Interventions
DRUGRegular Insulin
1,8U Regular insulin/h from 180mg/dL of blood glucose increasing each hour according to capillary blood glucose. Between 100-150mg/dL keep infusion and bellow 100mg/dL stop infusion
Sponsors
Emory University
Universidade Positivo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female * Age 18 or older * Evidence of AMI within the last 24 h (troponin-T \>0.1mcg/l) or electrographic criteria of ST-segment elevation in two limb leads) * Evidence of Unstable Angina * Blood glucose \>180mg/dL at admission with or without preexisting diabetes * Willing to give informed consent * Access to telephone communications after hospital discharge
Exclusion criteria
* Under 18 years of age * Pregnant or lactating female * Diabetes ketoacidosis * Heart failure * Cardiogenic shock
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in daily blood glucose mean concentration between treatment groups | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| Evaluating the performance of the insulin drip protocol to maintain target glucose control(TGC) | 18 month |
Countries
Brazil, United States
Outcome results
None listed