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Clinical Trials/NCT00289367
NCT00289367CompletedPhase 1

Randomized Prospective Study of T3 on the Incidence of Post-Operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery

Northwell Health1 site in 1 country280 target enrollmentStarted: February 1, 2006Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
280
Locations
1
Primary Endpoint
incidence of atrial fibrillation
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this project is to see whether treatment with a thyroid hormone, called triiodothyronine or T3, following open heart surgery reduces the risk of developing atrial fibrillation.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients requiring CABG or valve repair/replacement surgery.
  • •Patient must be able to provide informed consent.

Exclusion Criteria

  • •Patients less than 18 or over 85 years of age.
  • •Patients less than 50kg or greater than 120kg.
  • •Patients currently with endocrine disorders, excluding diabetes.
  • •Patients currently with thyroid dysfunction (e.g., hyper- hyperthyroidism, goiter, Grave's disease), myxedema, or myxedema coma, even if treated.
  • •Patients currently receiving thyroid replacement therapy.
  • •Patients currently receiving Ketamine, levarterenol or dietary (non-food) iodine supplementation.
  • •Patients who have received any investigational drugs within the previous one month or five half-lives of the drug.
  • •Patients who are pregnant. Pregnancy testing will be done for women of child-bearing potential.
  • •Patients currently in atrial fibrillation.

Outcomes

Primary Outcomes

incidence of atrial fibrillation

Time Frame: during hospitalization

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (1)

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Study of T3 on the Incidence of Atrial... | Clinical Trial