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

June 17, 2012 updated by: Silmara A O Leite, Universidade Positivo

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • PR
      • Curitiba, PR, Brazil, 80420-011
        • Hospital Cruz Vermelha Brasileira-Filial do Estado do Paraná
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Emory University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Insulin
Intensive Insulin Therapy
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
Other Names:
  • Novolin R
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

Other Names:
  • Novolin R
Other: Regular Insulin
Sub Cutaneous Regular Insulin
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
Other Names:
  • Novolin R
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

Other Names:
  • Novolin R

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Differences in daily blood glucose mean concentration between treatment groups
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluating the performance of the insulin drip protocol to maintain target glucose control(TGC)
Time Frame: 18 month
18 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Positivo

Collaborators

Emory University

Investigators

  • Principal Investigator: Silmara AO Leite, PhD, MD, Universidade Positivo
  • Study Chair: Guilhermo E Umpierrez, MD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

August 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

March 4, 2010

First Submitted That Met QC Criteria

June 25, 2010

First Posted (Estimate)

June 28, 2010

Study Record Updates

Last Update Posted (Estimate)

June 19, 2012

Last Update Submitted That Met QC Criteria

June 17, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCV-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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