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

Purpose

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

Cardiac Surgery

MedlinePlus related topics:

Kidney Failure

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective

Official Title:	Impact of Catecholamine-O-Methyl-Transferase Enzyme Activity on Clinical and Biological Parameters in Patients After Cardiac Surgery.

Further study details as provided by Austin Health:

Primary Outcome Measures:

duration of vasoplegia and incidence of acute renal failure following cardiopulmonary bypass

Secondary Outcome Measures:

length of stay in intensive care and in hospital, requirement of renal replacement therapy, mortality

Estimated Enrollment:	250
Study Start Date:	June 2006
Estimated Study Completion Date:	November 2006

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334009

Locations


Australia, Victoria
	Austin Hospital
	Melbourne, Victoria, Australia, 3084

Sponsors and Collaborators

Austin Health

Investigators


Principal Investigator:	Rinaldo Bellomo, MD, FRACP	Austin Health

Principal Investigator:	Duska Dragun, MD	Department of Nephrology, Charite University Hospital, Berlin

More Information

Study ID Numbers:	H2005/02320
First Received:	June 5, 2006
Last Updated:	March 3, 2008
ClinicalTrials.gov Identifier:	NCT00334009
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Austin Health:

Cardiac Surgery

Cardiopulmonary Bypass

COMT-Polymorphism

Vasoplegia

Catecholamines

Acute Renal Failure

Study placed in the following topic categories:

Kidney Failure, Acute

Kidney Failure

ClinicalTrials.gov processed this record on October 14, 2008

Sponsored by:	Austin Health
Information provided by:	Austin Health
ClinicalTrials.gov Identifier:	NCT00334009