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

NCT ID: NCT01151176

Last Updated: 2012-06-19

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE4
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-12-31

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.

Conditions

Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insulin

Intensive Insulin Therapy

Group Type: ACTIVE_COMPARATOR

Regular Insulin

Intervention Type: DRUG

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

Sub Cutaneous Regular Insulin

Group Type: OTHER

Regular Insulin

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

Novolin R; Novolin R

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: collaborator

Universidade Positivo

OTHER

Sponsor Role: lead

Responsible Party

Silmara A O Leite

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Silmara AO Leite, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Universidade Positivo

Guilhermo E Umpierrez, MD

Role: STUDY_CHAIR

Emory University

Locations

Emory University School of Medicine

Atlanta, Georgia, United States

Hospital Cruz Vermelha Brasileira-Filial do Estado do Paraná

Curitiba, Paraná, Brazil

Countries

United States; Brazil

Other Identifiers

HCV-001

Identifier Type: -

Identifier Source: org_study_id