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

Kavaklıdere Umut Hospital

Status and phase: Unknown; Phase 4

Conditions: Thyroid Hormones; Nitroprusside

Treatments: Drug: sodium nitroprusside; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00636584

2008-0048

Details and patient eligibility

About

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.

Enrollment: 106 estimated patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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106 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

arm1: sodium nitroprusside group

Treatment:

Drug: sodium nitroprusside

2

Placebo Comparator group

Description:

arm2: control group,saline infused instead of sodium nitroprusside

Treatment:

Drug: placebo