Whether use of SNP during cardiac surgery has any effect on thyroid function has not yet been investigated in humans. The aim of this study was to investigate the effects of SNP administration during the rewarming period of cardiac operations on circulating levels of thyroid hormones...
Date First Received: March 7, 2008
Last Updated: March 7, 2008
Verified by: Kavaklıdere Umut Hospital, March 2008
Clinical Trial Phase: Phase 4 | Start Date: February 2008
Overall Status: Recruiting
Estimated Enrollment: 106
Brief Summary
Official Title: “Does Sodium Nitroprusside Infusion Affect Thyroidal Function in Patients Undergoing Coronary Artery Bypass Grafting, a Prospective Randomized Clinical Trial.”
Condition Keyword(s):
Intervention(s):
Whether use of SNP during cardiac surgery has any effect on thyroid function has not yet been investigated in humans. The aim of this study was to investigate the effects of SNP administration during the rewarming period of cardiac operations on circulating levels of thyroid hormones.
Study Type: Interventional
Study Design: Screening, Randomized, Single Blind (Investigator), Parallel Assignment, Efficacy Study
Study Primary Completion Date: February 2008
Intervention(s) in this Clinical Trial
- Drug: sodium nitroprusside
- sodium nitroprusside infusion at 1 microgram/kg/min dose during rewarming period of cardiac operations
- Drug: placebo
- placebo
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- arm1: sodium nitroprusside group
- Placebo Comparator: 2
- arm2: control group,saline infused instead of sodium nitroprusside
Outcome Measures for this Clinical Trial
Primary Measures
- free T3
- Time Frame: on admission, prior to operation, at the beginning of CPB, following CPB, at first, third and fifth postoperative days
Safety Issue?: No
- Time Frame: on admission, prior to operation, at the beginning of CPB, following CPB, at first, third and fifth postoperative days
Secondary Measures
- total T3
- Time Frame: on admission, prior to operation, at the beginning of CPB, following CPB, on the first, third and fifth postoperative days
Safety Issue?: No
- Time Frame: on admission, prior to operation, at the beginning of CPB, following CPB, on the first, third and fifth postoperative days
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
Patients without history of:
- thyroidal disease
- hypertension
- pulmonary disease
- peripheral vascular disease
- stroke
- recent myocardial infarction within the week prior to operation
- unstable angina pectoris
- liver or kidney dysfunction
- morbid obesity
- cachexia
- sulfonylurea intake
Exclusion Criteria:
- Patients who needed positive inotropic pharmacologic support during or after the operation
- Patients who developed atrial fibrillation in the post operative period requiring amiodarone therapy
- In addition, patients receiving any medication known to interfere with any step of thyroid hormone metabolism such as
- amiodarone
- propranolol
- furosemide
- non-steroidal anti-inflammatory agents
- steroids
- estrogens
- antacids
- diphenylhydantoin
- spironolactone
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 30 Years
Maximum Age for this Clinical Trial: 85 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Kavaklıdere Umut Hospital
Overall Clinical Trial Officials and Contacts
alp aslan, md Study Director kavaklıdere Umut Hastanesi, Turkey
Overall Contact: alp aslan, md 0905425179917 alpslan@yahoo.com
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00636584
Study ID Number: 2008-0048
ClinicalTrials.gov Identifier: NCT00636584
Health Authority: Turkey: Ministry of Health
Clinical Trials Authorship and Review
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