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

Primary Purpose

Hyperglycemia

Status
Terminated
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Insulin
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperglycemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Eduesley Santana Santos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Conventional Group

Moderate Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Infection of surgical wound infection
The primary outcome measure will be assessed according to the American Society of Thoracic Surgeons guidelines

Secondary Outcome Measures

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

Full Information

First Posted
October 8, 2015
Last Updated
October 31, 2022
Sponsor
University of Sao Paulo
Collaborators
InCor Heart Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02574156
Brief Title
Control of Hyperglycemia After Cardiac Surgery: CHyCS Trial
Acronym
CHyCS
Official Title
Control of Hyperglycemia After Cardiac Surgery: CHyCS Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Finished
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
April 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
InCor Heart Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators aim to study the impact of a strategy of a intensive glycemic control in patients undergoing cardiac surgery.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Moderate Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Insulin
Other Intervention Name(s)
Glycemic Control
Intervention Description
All patients will receive insulin. However, the infusion flow will be different according to the group.
Primary Outcome Measure Information:
Title
Infection of surgical wound infection
Description
The primary outcome measure will be assessed according to the American Society of Thoracic Surgeons guidelines
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Need for reoperation
Description
This outcome measure will be assessed according to the American Society of Thoracic Surgeons guidelines
Time Frame
30 days
Title
Acute renal injury (defined by the KDIGO classification)
Description
This outcome measure will be assessed according to the KDIGO Criterion
Time Frame
30 days
Title
Infection of the bloodstream
Time Frame
90 days
Title
Prolonged mechanical ventilation
Time Frame
90 days
Title
Need for transfusion of blood products
Time Frame
90 days
Title
Occurrences of hypoglycemia
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduesley Santana Santos, Ph.D
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eduesley Santana Santos
City
São Paulo
ZIP/Postal Code
01307-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
24401049
Citation
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Results Reference
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16738506
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
19636533
Citation
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Results Reference
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PubMed Identifier
16075050
Citation
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Results Reference
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PubMed Identifier
8993292
Citation
Boyle EM Jr, Pohlman TH, Johnson MC, Verrier ED. Endothelial cell injury in cardiovascular surgery: the systemic inflammatory response. Ann Thorac Surg. 1997 Jan;63(1):277-84. doi: 10.1016/s0003-4975(96)01061-2.
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Citation
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Results Reference
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Control of Hyperglycemia After Cardiac Surgery: CHyCS Trial

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