Clinical Study Investigating the Effect of Sodium Nitroprusside Infusion on Thyroidal Function
Does Sodium Nitroprusside Infusion Affect Thyroidal Function in Patients Undergoing Coronary Artery Bypass Grafting, a Prospective Randomized Clinical Trial.
1 other identifier
interventional
106
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2008
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 7, 2008
CompletedFirst Posted
Study publicly available on registry
March 14, 2008
CompletedMarch 14, 2008
March 1, 2008
Same day
March 7, 2008
March 7, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
free T3
on admission, prior to operation, at the beginning of CPB, following CPB, at first, third and fifth postoperative days
Secondary Outcomes (1)
total T3
on admission, prior to operation, at the beginning of CPB, following CPB, on the first, third and fifth postoperative days
Study Arms (2)
1
EXPERIMENTALarm1: sodium nitroprusside group
2
PLACEBO COMPARATORarm2: control group,saline infused instead of sodium nitroprusside
Interventions
sodium nitroprusside infusion at 1 microgram/kg/min dose during rewarming period of cardiac operations
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kavaklıdere Umut Hospitallead
- Ankara Universitycollaborator
Study Sites (1)
Kavaklıdere Umut Hastanesi
Ankara, 06660, Turkey (Türkiye)
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
alp aslan, md
kavaklıdere Umut Hastanesi, Turkey
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 7, 2008
First Posted
March 14, 2008
Study Start
February 1, 2008
Primary Completion
February 1, 2008
Study Completion
March 1, 2008
Last Updated
March 14, 2008
Record last verified: 2008-03