Feasible Insulin Algorithm for Glycemic Control in Patients With Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

Official title:

Phase IV Study of a Feasible Insulin Algorithm for Glycemic Control in Patients With Acute Coronary Syndrome

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01151176
• Other study ID #: HCV-001
• Status: Suspended
• Phase: Phase 4
• First received: March 4, 2010
• Last updated: June 17, 2012
• Start date: August 2012
• Est. completion date: December 2013

Study information

• Verified date: June 2012
• Source: Universidade Positivo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 130
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Regular 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
• Regular Insulin
Regular Insulin SC according to Blood Glucose(mg/dL) and Insulin Sensitive with usual dose describe and less 2U for sensitive and plus 2U for insulin resistant: Blood Glucose >141-180=4U ;181-220=6U; 221-260=8U; 261-300=10U;301-350=12U; 351-400=14U; > 400=16U

Locations

Country	Name	City	State
Brazil	Hospital Cruz Vermelha Brasileira-Filial do Estado do Paraná	Curitiba	PR
United States	Emory University School of Medicine	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Positivo	Emory University

Countries where clinical trial is conducted

United States,  Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in daily blood glucose mean concentration between treatment groups		18 months	Yes
Secondary	Evaluating the performance of the insulin drip protocol to maintain target glucose control(TGC)		18 month	Yes