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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00636584
Recruitment Status : Unknown
Verified March 2008 by Kavaklıdere Umut Hospital.
Recruitment status was:  Recruiting
First Posted : March 14, 2008
Last Update Posted : March 14, 2008
Ankara University
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Nitroprusside Thyroid Hormones Drug: sodium nitroprusside Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Screening
Official Title: Does Sodium Nitroprusside Infusion Affect Thyroidal Function in Patients Undergoing Coronary Artery Bypass Grafting, a Prospective Randomized Clinical Trial.
Study Start Date : February 2008
Actual Primary Completion Date : February 2008
Estimated Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
arm1: sodium nitroprusside group
Drug: sodium nitroprusside
sodium nitroprusside infusion at 1 microgram/kg/min dose during rewarming period of cardiac operations
Other Name: nipruss

Placebo Comparator: 2
arm2: control group,saline infused instead of sodium nitroprusside
Drug: placebo

Primary Outcome Measures :
  1. free T3 [ Time Frame: on admission, prior to operation, at the beginning of CPB, following CPB, at first, third and fifth postoperative days ]

Secondary Outcome Measures :
  1. total T3 [ Time Frame: on admission, prior to operation, at the beginning of CPB, following CPB, on the first, third and fifth postoperative days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00636584

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Contact: alp aslan, md 0905425179917

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Kavaklıdere Umut Hastanesi Recruiting
Ankara, Turkey, 06660
Contact: Alp Aslan, MD    0905425179917   
Contact: Selen Osmanağaoğlu, MD    0905324675969   
Principal Investigator: alp aslan, MD         
Sponsors and Collaborators
Kavaklıdere Umut Hospital
Ankara University
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Study Director: alp aslan, md kavaklıdere Umut Hastanesi, Turkey

Additional Information:
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Responsible Party: Kavaklıdere Umut Hastanesi, Kavaklıdere Umut Hospital, department of cardiovascular surgery Identifier: NCT00636584     History of Changes
Other Study ID Numbers: 2008-0048
First Posted: March 14, 2008    Key Record Dates
Last Update Posted: March 14, 2008
Last Verified: March 2008
Keywords provided by Kavaklıdere Umut Hospital:
sodium nitroprusside
thyroid hormones
thoracic surgery
Additional relevant MeSH terms:
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Thyroid Diseases
Endocrine System Diseases
Antihypertensive Agents
Vasodilator Agents
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action