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

March 7, 2008 updated by: Kavaklıdere Umut Hospital

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

106

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Ankara, Turkey, 06660
        • Recruiting
        • Kavaklıdere Umut Hastanesi
        • Contact:
        • Contact:
        • Principal Investigator:
          • alp aslan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • nipruss
Placebo Comparator: 2
arm2: control group,saline infused instead of sodium nitroprusside
Drug: placebo
placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
free T3
Time Frame: on admission, prior to operation, at the beginning of CPB, following CPB, at first, third and fifth postoperative days
on admission, prior to operation, at the beginning of CPB, following CPB, at first, third and fifth postoperative days

Secondary Outcome Measures

Outcome Measure
Time Frame
total T3
Time Frame: on admission, prior to operation, at the beginning of CPB, following CPB, on the first, third and fifth postoperative days
on admission, prior to operation, at the beginning of CPB, following CPB, on the first, third and fifth postoperative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kavaklıdere Umut Hospital

Collaborators

Ankara University

Investigators

  • Study Director: alp aslan, md, kavaklıdere Umut Hastanesi, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

February 1, 2008

Study Completion (Anticipated)

March 1, 2008

Study Registration Dates

First Submitted

March 7, 2008

First Submitted That Met QC Criteria

March 7, 2008

First Posted (Estimate)

March 14, 2008

Study Record Updates

Last Update Posted (Estimate)

March 14, 2008

Last Update Submitted That Met QC Criteria

March 7, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-0048

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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