Perioperative Versus Postoperative Glycemia Control in Cardiac Surgery Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jan Blaha, MD, PhD., Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT01548963
First received: February 25, 2012
Last updated: April 6, 2013
Last verified: April 2013
  Purpose

It is known that acute stress of organism often leads to hyperglycemia even in nondiabetic patients. It is also known that pathophysiological mechanisms: enhanced gluconeogenesis, impaired insulin secretion and decreased insulin sensitivity due to anti-insulin effect of stress hormones and proinflammatory cytokines, or changes of glucose excretion and renal tubular resorption.

Many studies proved the negative effects of hyperglycemia to different tissues and organs, e.g. hearth (increasing size of myocardial necrosis, reducing coronary collateral blood flow, exaggerating ischemia-reperfusion injury, impairing ischemic preconditioning), vascular (increased risk of thrombosis, endothelial dysfunction, activation of systemic inflammation with destabilization of atherosclerotic plaques), kidneys and its association with infectious complications.

The first Leuven study (published in 2001) demonstrated that hyperglycemia in critical care patients significantly increases risk of organ complication and total mortality. Although the importance of postoperative tight glycemia control is now widely accepted, glycemia stability during cardiac surgery is often neglected. It is known that postoperative hyperglycemia has negative effects, but it is not known what effect has its peroperative elevation.

Goal of this study is to demonstrate, whether full perioperative intensive glycemia control can reduce the incidence of postoperative morbidity even more than postoperative glycemia control only.


Condition Intervention
Perioperative and Postoperative Hyperglycemia
Tight Glycemia Control
Procedure: Intensive glycemia control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Perioperative Versus Postoperative Glycemia Control in Cardiac Surgery Patients

Resource links provided by NLM:


Further study details as provided by Charles University, Czech Republic:

Primary Outcome Measures:
  • Morbidity comparison of perioperative vs. postoperative glycemia control [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Number of postoperative complications in 30 days following cardiac surgery.


Secondary Outcome Measures:
  • mortality [ Time Frame: in-hospital, 30 day ] [ Designated as safety issue: Yes ]
    in-hospital and 30-Day mortality, ICU time


Enrollment: 2384
Study Start Date: January 2007
Study Completion Date: June 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Perioperative glycemia control
Group of perioperative intensive glycemia control: blood glucose level will be maintained by continuous insulin infusion (Actrapid, Novo Nordisk A/S, Bagsvaerd, Danemark - 50 IU/50 ml FR) according to actual glycemia to keep it within normoglycemia limits (4.2 - 6.1 mmol/l) since patient's admission to operating room. Samplings will be taken in 1 to 4 hours intervals in accordance with glycemia stability and MPC algorithm suggestions.
Procedure: Intensive glycemia control
Blood glucose levels will be maintained by continuous insulin infusion (Actrapid, Novo Nordisk A/S, Bagsvaerd, Danemark - 50 IU/50 ml FR) within normoglycemia limits (4.2 - 6.1 mmol/l)
Other Names:
  • Tight glycemia control
  • Blood glucose control
Active Comparator: Postoperative glycemia control
Group of standard glycemia control: blood glucose level will be maintained by continuous insulin infusion (see above) within normoglycemia limits (4.2 - 6.1 mmol/l) after patient's admission to ICU after cardiac surgery. During surgery hyperglycemia will not be interfered before it will reach level of 10 mmol/l.
Procedure: Intensive glycemia control
Blood glucose levels will be maintained by continuous insulin infusion (Actrapid, Novo Nordisk A/S, Bagsvaerd, Danemark - 50 IU/50 ml FR) within normoglycemia limits (4.2 - 6.1 mmol/l)
Other Names:
  • Tight glycemia control
  • Blood glucose control

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing cardiac surgery
  • men and women
  • aged 18-90 years
  • signed informed consent

Exclusion Criteria:

  • patient's dissent
  • allergy to insulin or other components added to insulin solution
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01548963

Locations
Czech Republic
General University Hospital Prague
Prague, Czech Republic, 128 51
Sponsors and Collaborators
Charles University, Czech Republic
Investigators
Principal Investigator: Jan Blaha, M.D., PhD. 1st Faculty of Medicine, Charles University in Prague
  More Information

Publications:
Responsible Party: Jan Blaha, MD, PhD., Principal Investigator, Charles University, Czech Republic
ClinicalTrials.gov Identifier: NCT01548963     History of Changes
Other Study ID Numbers: eMPC_long
Study First Received: February 25, 2012
Last Updated: April 6, 2013
Health Authority: Czech Republic: Ethics Committee

Keywords provided by Charles University, Czech Republic:
Tight glycemia control
Model Predictive Control algorithm
Cardiac surgery patients

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 14, 2014