Control of Hyperglycemia After Cardiac Surgery: CHyCS Trial

Hyperglycemia Clinical Trial

— CHyCS  

Official title:

Control of Hyperglycemia After Cardiac Surgery: CHyCS Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02574156
• Other study ID #: SDC
• Status: Terminated
• Phase: Phase 3
• Start date: January 1, 2017
• Est. completion date: April 1, 2019

Study information

• Verified date: October 2022
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 500
• Est. completion date: April 1, 2019
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperglycemia

Intervention

Drug:
• Insulin
All patients will receive insulin. However, the infusion flow will be different according to the group.

Locations

Country	Name	City	State
Brazil	Eduesley Santana Santos	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	InCor Heart Institute

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

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. Review. — View Citation

Brunkhorst FM, Engel C, Bloos F, Meier-Hellmann A, Ragaller M, Weiler N, Moerer O, Gruendling M, Oppert M, Grond S, Olthoff D, Jaschinski U, John S, Rossaint R, Welte T, Schaefer M, Kern P, Kuhnt E, Kiehntopf M, Hartog C, Natanson C, Loeffler M, Reinhart — View Citation

Dandona P, Mohanty P, Chaudhuri A, Garg R, Aljada A. Insulin infusion in acute illness. J Clin Invest. 2005 Aug;115(8):2069-72. — View Citation

Macrae D, Grieve R, Allen E, Sadique Z, Morris K, Pappachan J, Parslow R, Tasker RC, Elbourne D; CHiP Investigators. A randomized trial of hyperglycemic control in pediatric intensive care. N Engl J Med. 2014 Jan 9;370(2):107-18. doi: 10.1056/NEJMoa130256 — View Citation

NICE-SUGAR Study Investigators, Finfer S, Chittock DR, Su SY, Blair D, Foster D, Dhingra V, Bellomo R, Cook D, Dodek P, Henderson WR, Hébert PC, Heritier S, Heyland DK, McArthur C, McDonald E, Mitchell I, Myburgh JA, Norton R, Potter J, Robinson BG, Ronco — View Citation

Preiser JC, Devos P, Ruiz-Santana S, Mélot C, Annane D, Groeneveld J, Iapichino G, Leverve X, Nitenberg G, Singer P, Wernerman J, Joannidis M, Stecher A, Chioléro R. A prospective randomised multi-centre controlled trial on tight glucose control by intens — View Citation

Shahian DM, O'Brien SM, Filardo G, Ferraris VA, Haan CK, Rich JB, Normand SL, DeLong ER, Shewan CM, Dokholyan RS, Peterson ED, Edwards FH, Anderson RP; Society of Thoracic Surgeons Quality Measurement Task Force. The Society of Thoracic Surgeons 2008 card — View Citation

Yates AR, Dyke PC 2nd, Taeed R, Hoffman TM, Hayes J, Feltes TF, Cua CL. Hyperglycemia is a marker for poor outcome in the postoperative pediatric cardiac patient. Pediatr Crit Care Med. 2006 Jul;7(4):351-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infection of surgical wound infection	The primary outcome measure will be assessed according to the American Society of Thoracic Surgeons guidelines	30 days
Secondary	Need for reoperation	This outcome measure will be assessed according to the American Society of Thoracic Surgeons guidelines	30 days
Secondary	Acute renal injury (defined by the KDIGO classification)	This outcome measure will be assessed according to the KDIGO Criterion	30 days
Secondary	Infection of the bloodstream		90 days
Secondary	Prolonged mechanical ventilation		90 days
Secondary	Need for transfusion of blood products		90 days
Secondary	Occurrences of hypoglycemia		90 days