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

Phase 4

• Conditions: Nitroprusside; Thyroid Hormones
• Interventions: Drug: sodium nitroprusside; Drug: placebo

• Registration Number: NCT00636584
• Lead Sponsor: Kavaklıdere Umut Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2008-02
• Status Verified: 2008-03
• Study Completion: 2008-03
• Study First Submitted: 2008-03-07
• Study First Submitted QC: 2008-03-07
• Last Update Submitted: 2008-03-07
• Study First Posted: 2008-03-14
• Last Update Posted: 2008-03-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	sodium nitroprusside	arm1: sodium nitroprusside group
2	placebo	arm2: control group,saline infused instead of sodium nitroprusside

Primary Outcome Measures

Name	Time	Method
free T3	on admission, prior to operation, at the beginning of CPB, following CPB, at first, third and fifth postoperative days

Secondary Outcome Measures

Name	Time	Method
total T3	on admission, prior to operation, at the beginning of CPB, following CPB, on the first, third and fifth postoperative days

Trial Locations

Locations (1)

Kavaklıdere Umut Hastanesi; 🇹🇷 Ankara, Turkey