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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Nitroprusside Thyroid Hormones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

arm1: sodium nitroprusside group

Group Type EXPERIMENTAL

sodium nitroprusside

Intervention Type DRUG

sodium nitroprusside infusion at 1 microgram/kg/min dose during rewarming period of cardiac operations

2

arm2: control group,saline infused instead of sodium nitroprusside

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo

Interventions

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sodium nitroprusside

sodium nitroprusside infusion at 1 microgram/kg/min dose during rewarming period of cardiac operations

Intervention Type DRUG

placebo

Intervention Type DRUG

Other Intervention Names

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nipruss

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No