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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Kavaklıdere Umut Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ankara University
Information provided by:
Kavaklıdere Umut Hospital
ClinicalTrials.gov Identifier:
NCT00636584
First received: March 7, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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 Intervention Phase
Nitroprusside
Thyroid Hormones
Drug: sodium nitroprusside
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:


Further study details as provided by Kavaklıdere Umut Hospital:

Primary Outcome Measures:
  • free T3 [ Time Frame: on admission, prior to operation, at the beginning of CPB, following CPB, at first, third and fifth postoperative days ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 106
Study Start Date: February 2008
Estimated Study Completion Date: March 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
placebo

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636584

Contacts
Contact: alp aslan, md 0905425179917 alpslan@yahoo.com

Locations
Turkey
Kavaklıdere Umut Hastanesi Recruiting
Ankara, Turkey, 06660
Contact: Alp Aslan, MD    0905425179917    alpslan@yahoo.com   
Contact: Selen Osmanağaoğlu, MD    0905324675969    sosmanaga@gmail.com   
Principal Investigator: alp aslan, MD         
Sponsors and Collaborators
Kavaklıdere Umut Hospital
Ankara University
Investigators
Study Director: alp aslan, md kavaklıdere Umut Hastanesi, Turkey
  More Information

No publications provided

Responsible Party: Kavaklıdere Umut Hastanesi, Kavaklıdere Umut Hospital, department of cardiovascular surgery
ClinicalTrials.gov Identifier: NCT00636584     History of Changes
Other Study ID Numbers: 2008-0048
Study First Received: March 7, 2008
Last Updated: March 7, 2008
Health Authority: Turkey: Ministry of Health

Keywords provided by Kavaklıdere Umut Hospital:
sodium nitroprusside
thyroid hormones
thoracic surgery

Additional relevant MeSH terms:
Thyroid Diseases
Endocrine System Diseases
Nitroprusside
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents

ClinicalTrials.gov processed this record on July 26, 2014