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Catecholamine-O-Methyl-Transferase(COMT)-Polymorphism in Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT00334009
Recruitment Status : Completed
First Posted : June 6, 2006
Last Update Posted : March 6, 2008
Sponsor:
Information provided by:
Austin Health

Brief Summary:

Although clinical risk factors for postoperative development of vasodilatory shock and acute renal failure have been identified; there is a considerable proportion of patients undergoing cardiac surgery where this syndrome cannot be predicted.

We sought to investigate the impact of Catecholamine-O-Methyltransferase (COMT) polymorphism on the duration of vasodilatory shock and other important clinical outcomes in cardiac surgery patients.

COMT is a key enzyme in the degradation of catechols eg. catecholamines. 25% of the population have a low activity (L/L) of this enzyme. Sustained low COMT activity is associated with an altered metabolic profile of catecholamines and their degradation products.

The process of cardiopulmonary bypass (CPB)over-activates some of the same mechanisms the body uses to defend itself against severe infection. One of the main overactive defence mechanisms is the release of highly toxic compounds derived from oxygen - a process called 'oxidative-stress'. Increased reactive oxygen species (ROS) generation can lead to inactivation of biologic mediators, including catecholamines. It is well established that some radicals autoxidizes catecholamines, including DA, NE, and epinephrine and contribute significantly to vasoplegia.

As part of this study, we will take six 2.7mL samples of blood, collected before, and after the operation, from the arterial catheter routinely inserted in every patient. This blood will be used to measure COMT genotype, the concentration of plasma-catecholamines as well as marker of oxidative stress.

Our plan is to enrol patients undergoing cardiac surgery if the use of the CPB is planned.


Condition or disease
Cardiac Surgery

  Show Detailed Description

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Study Type : Observational
Enrollment : 250 participants
Time Perspective: Prospective
Official Title: Impact of Catecholamine-O-Methyl-Transferase Enzyme Activity on Clinical and Biological Parameters in Patients After Cardiac Surgery.
Study Start Date : June 2006
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery




Primary Outcome Measures :
  1. duration of vasoplegia and incidence of acute renal failure following cardiopulmonary bypass

Secondary Outcome Measures :
  1. length of stay in intensive care and in hospital, requirement of renal replacement therapy, mortality


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing elective cardiac surgery (in whom CPB is planned) at the Austin Hospital and Warringal Private Hospital.

Exclusion Criteria:

  • Intake of Levodopa
  • Intake of COMT inhibitors (e.g. Entacapone, Tolcapone)
  • Intake of monoamino oxidase inhibitors type A and B (e.g. Moclobemide, Selegiline, Rasagiline)
  • Patients below 18 years of age
  • oral steroids
  • emergency patients (cardiac symptoms occurred < 24 hours prior to operation)
  • patients receiving IV nitrates/nitroprusside sodium

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334009


Locations
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Australia, Victoria
Austin Hospital
Melbourne, Victoria, Australia, 3084
Sponsors and Collaborators
Austin Health
Investigators
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Principal Investigator: Rinaldo Bellomo, MD, FRACP Austin Health
Principal Investigator: Duska Dragun, MD Department of Nephrology, Charite University Hospital, Berlin

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00334009     History of Changes
Other Study ID Numbers: H2005/02320
First Posted: June 6, 2006    Key Record Dates
Last Update Posted: March 6, 2008
Last Verified: March 2008

Keywords provided by Austin Health:
Cardiac Surgery
Cardiopulmonary Bypass
COMT-Polymorphism
Vasoplegia
Catecholamines
Acute Renal Failure