Back to resultsClinical Study Investigating the Effect of Sodium Nitroprusside Infusion on Thyroidal Function
Primary Purpose
Nitroprusside, Thyroid Hormones
Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
sodium nitroprusside
placebo
Sponsored by
About this trial
This is an interventional screening trial for Nitroprusside focused on measuring sodium nitroprusside, thyroid hormones, thoracic surgery
Eligibility 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
Sites / Locations
- Kavaklıdere Umut HastanesiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
arm1: sodium nitroprusside group
arm2: control group,saline infused instead of sodium nitroprusside
Outcomes
Primary Outcome Measures
free T3
Secondary Outcome Measures
total T3
Full Information
NCT ID
NCT00636584
First Posted
March 7, 2008
Last Updated
March 7, 2008
Sponsor
Kavaklıdere Umut Hospital
Collaborators
Ankara University
1. Study Identification
Unique Protocol Identification Number
NCT00636584
Brief Title
Clinical Study Investigating the Effect of Sodium Nitroprusside Infusion on Thyroidal Function
Official Title
Does Sodium Nitroprusside Infusion Affect Thyroidal Function in Patients Undergoing Coronary Artery Bypass Grafting, a Prospective Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
March 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Kavaklıdere Umut Hospital
Collaborators
Ankara University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nitroprusside, Thyroid Hormones
Keywords
sodium nitroprusside, thyroid hormones, thoracic surgery
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
106 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
arm1: sodium nitroprusside group
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
arm2: control group,saline infused instead of sodium nitroprusside
Intervention Type
Drug
Intervention Name(s)
sodium nitroprusside
Other Intervention Name(s)
nipruss
Intervention Description
sodium nitroprusside infusion at 1 microgram/kg/min dose during rewarming period of cardiac operations
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
total T3
Time Frame
on admission, prior to operation, at the beginning of CPB, following CPB, on the first, third and fifth postoperative days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
alp aslan, md
Phone
0905425179917
Email
alpslan@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
alp aslan, md
Organizational Affiliation
kavaklıdere Umut Hastanesi, Turkey
Official's Role
Study Director
Facility Information:
Facility Name
Kavaklıdere Umut Hastanesi
City
Ankara
ZIP/Postal Code
06660
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alp Aslan, MD
Phone
0905425179917
Email
alpslan@yahoo.com
First Name & Middle Initial & Last Name & Degree
Selen Osmanağaoğlu, MD
Phone
0905324675969
Email
sosmanaga@gmail.com
First Name & Middle Initial & Last Name & Degree
alp aslan, MD
12. IPD Sharing Statement
Links:
URL
http://www.cityhospital.com.tr/
Description
home page of kavaklidere umut hospital
Learn more about this trial
Clinical Study Investigating the Effect of Sodium Nitroprusside Infusion on Thyroidal Function
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