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

This study has been completed.
Sponsor:
Information provided by:
Austin Health
ClinicalTrials.gov Identifier:
NCT00334009
First received: June 5, 2006
Last updated: March 3, 2008
Last verified: March 2008
  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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Impact of Catecholamine-O-Methyl-Transferase Enzyme Activity on Clinical and Biological Parameters in Patients After Cardiac Surgery.

Resource links provided by NLM:


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
  Show Detailed Description

  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

No publications provided by Austin Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00334009     History of Changes
Other Study ID Numbers: H2005/02320
Study First Received: June 5, 2006
Last Updated: March 3, 2008
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

ClinicalTrials.gov processed this record on June 17, 2013