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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00334009

Registration number

NCT00334009

Ethics application status

Date submitted

5/06/2006

Date registered

6/06/2006

Date last updated

6/03/2008

Titles & IDs

Public title

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

Scientific title

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

Secondary ID [1]

H2005/02320

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cardiac Surgery

Condition category

Condition code

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

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

Timepoint [1]

Secondary outcome [1]

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

Timepoint [1]

Eligibility

Key inclusion criteria

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

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key 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

Study design

Purpose

Duration

Selection

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/06/2006

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Hospital - Melbourne

Recruitment postcode(s) [1]

3084 - Melbourne

Funding & Sponsors

Primary sponsor type

Government body

Name

Austin Health

Address

Country

Ethics approval

Ethics application status

Summary

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.

Trial website

https://clinicaltrials.gov/study/NCT00334009

Trial related presentations / publications

Haase-Fielitz A, Haase M, Bellomo R, Lambert G, Matalanis G, Story D, Doolan L, Buxton B, Gutteridge G, Luft FC, Schunck WH, Dragun D. Decreased catecholamine degradation associates with shock and kidney injury after cardiac surgery. J Am Soc Nephrol. 2009 Jun;20(6):1393-403. doi: 10.1681/ASN.2008080915. Epub 2009 Apr 30.

Public notes

Contacts

Principal investigator

Name

Rinaldo Bellomo, MD, FRACP

Address

Austin Health

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00334009

Trial Review

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00334009