Clinical Study Investigating the Effect of Sodium Nitroprusside Infusion on Thyroidal Function

Thyroid Hormones Clinical Trial

Official title:

Does Sodium Nitroprusside Infusion Affect Thyroidal Function in Patients Undergoing Coronary Artery Bypass Grafting, a Prospective Randomized Clinical Trial.

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00636584
• Other study ID #: 2008-0048
• Status: Unknown status
• Phase: Phase 4
• First received: March 7, 2008
• Last updated: March 7, 2008
• Start date: February 2008
• Est. completion date: March 2008

Study information

• Verified date: March 2008
• Source: Kavaklidere Umut Hospital
• Contact: alp aslan, md
• Phone: 0905425179917
• Email: alpslan[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 106
• Est. completion date: March 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Nitroprusside
• Thyroid Hormones

Intervention

Drug:
• sodium nitroprusside
sodium nitroprusside infusion at 1 microgram/kg/min dose during rewarming period of cardiac operations
• placebo
placebo

Locations

Country	Name	City	State
Turkey	Kavaklidere Umut Hastanesi	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Kavaklidere Umut Hospital	Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	free T3		on admission, prior to operation, at the beginning of CPB, following CPB, at first, third and fifth postoperative days
Secondary	total T3		on admission, prior to operation, at the beginning of CPB, following CPB, on the first, third and fifth postoperative days

External Links

•   home page of kavaklidere umut hospital