Control of Hyperglycemia After Cardiac Surgery: CHyCS Trial (CHyCS)

October 31, 2022 updated by: Eduesley Santana Santos, University of Sao Paulo
The investigators aim to study the impact of a strategy of a intensive glycemic control in patients undergoing cardiac surgery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Patients undergoing heart surgery at the Heart Institute (InCor) will be randomized and in accordance with a list of random numbers, generated by a computer program, are allocated in one of the treatment groups (conventional or intensive) when the blood glucose value recorded is greater than 200 mg/dl on two consecutive measures in an interval of 30 minutes.Conventional Group (GCon): patients randomized to the conventional group will receive insulin infusion in a dilution of 100 units of regular insulin in 100 ml of physiological solution (NaCl 0.9%) in continuous infusion pump for maintenance of blood glucose between 140 mg/dl and 180 mg/dl.

Group intensive (GInt): patients randomized to the intensive group will receive insulin infusion in a dilution of 100 units of regular insulin in 100 ml of physiological solution (NaCl 0.9%) in continuous infusion pump for maintenance of blood glucose between 90 mg/dl and 110 mg/dl.

The insulin dose adjustment will be based on measurements of arterial blood glucose undiluted, held at intervals of one to 4 hours with the use of a monitoring system of glucose and beta-blood ketone (Freestyle Precision Pro, Abbott). The dosage is adjusted according to an algorithm by a team of intensive care nurses, trained for this purpose and assisted by a study physician not involved in the clinical care of patients.

On admission, all patients will receive intravenous glucose solution continuously (200 to 300 g in 24 hours). As soon as possible, the patient will be nurtured according to the routine of Surgical ICU for nutrition in the postoperative period of cardiac surgery patient.

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Phase 3

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
      • São Paulo, Brazil, 01307-000
        • Eduesley Santana Santos

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing heart surgery;
  • Age greater than 18 years;
  • Sign the informed consent form;
  • Capillary blood glucose greater than 200mg/dL ICU admission

Exclusion Criteria:

  • Admitted for surgical repair of congenital heart defects;
  • Dialytic Chronic renal failure;
  • Participation in other research protocol;
  • Diagnosis of HIV/AIDS;
  • Pregnant.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conventional Group
Patients randomized for Conventional Group will receive insulin infusion of regular insulin (100 UI) in 100 mL of saline in continuous infusion pump for maintenance of blood glucose between 140 mg/dl and 180 mg/dl.
Drug: Insulin
All patients will receive insulin. However, the infusion flow will be different according to the group.
Other Names:
  • Glycemic Control
Experimental: Moderate Group
Patients randomized for ModerateGroup will receive insulin infusion of regular insulin (100 UI) in 100 mL of saline in continuous infusion pump for maintenance of blood glucose between 100 mg/dl and 130 mg/dl.
Drug: Insulin
All patients will receive insulin. However, the infusion flow will be different according to the group.
Other Names:
  • Glycemic Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infection of surgical wound infection
Time Frame: 30 days
The primary outcome measure will be assessed according to the American Society of Thoracic Surgeons guidelines
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for reoperation
Time Frame: 30 days
This outcome measure will be assessed according to the American Society of Thoracic Surgeons guidelines
30 days
Acute renal injury (defined by the KDIGO classification)
Time Frame: 30 days
This outcome measure will be assessed according to the KDIGO Criterion
30 days
Infection of the bloodstream
Time Frame: 90 days
90 days
Prolonged mechanical ventilation
Time Frame: 90 days
90 days
Need for transfusion of blood products
Time Frame: 90 days
90 days
Occurrences of hypoglycemia
Time Frame: 90 days
90 days

Collaborators and Investigators

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

Sponsor

University of Sao Paulo

Collaborators

InCor Heart Institute

Investigators

  • Principal Investigator: Eduesley Santana Santos, Ph.D, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 1, 2017

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

October 8, 2015

First Submitted That Met QC Criteria

October 9, 2015

First Posted (Estimate)

October 12, 2015

Study Record Updates

Last Update Posted (Actual)

November 4, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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