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Status unknownNCT00636584Updated Mar 14, 2008

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

A Phase 4 interventional study of sodium nitroprusside and placebo in Nitroprusside and Thyroid Hormones, sponsored by Kavaklıdere Umut Hospital. Status unknown at 1 site in Turkey. Open to participants aged 30 Years to 85 Years. Per ClinicalTrials.gov, last updated 2008-03-14.

Sponsored by Kavaklıdere Umut Hospital · Phase 4, Interventional, and Screening

The sponsor has not verified this record recently (last verified Mar 2008), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
106
Allocation
Randomized
Ages
30 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Nitroprusside
  • Thyroid Hormones

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Keywords

  • sodium nitroprusside
  • thyroid hormones
  • thoracic surgery
03

In context

Thyroid Diseases

967 studies on the registry are indexed under Thyroid Diseases; 197 are open to participants now.

This study's planned enrollment of 106 is above the median of 60 across 544 interventional studies indexed under Thyroid Diseases.

Browse Thyroid Diseases studies →

Lead sponsor

Kavaklıdere Umut Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
106 participants (estimated)

Study arms

  • Experimental
    1

    arm1: sodium nitroprusside group

    Drug: sodium nitroprusside

  • Placebo comparator
    2

    arm2: control group,saline infused instead of sodium nitroprusside

    Drug: placebo

Interventions

  • Drugsodium nitroprusside

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

    Also known as: nipruss

  • Drugplacebo

    placebo

06

What researchers measure

Primary outcomes

  1. free T3

    Time frame: on admission, prior to operation, at the beginning of CPB, following CPB, at first, third and fifth postoperative days

Secondary outcomes

  1. total T3

    Time frame: on admission, prior to operation, at the beginning of CPB, following CPB, on the first, third and fifth postoperative days

07

Study locations

1 of 1 sites recruiting
  • Kavaklıdere Umut Hastanesi
    Ankara, 06660, Turkey
    Recruiting
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00636584
Lead sponsor
Kavaklıdere Umut Hospital
Collaborators
Ankara University
First posted
Mar 14, 2008
Start date
Feb 2008
Primary completion
Feb 2008
Completion
Mar 2008 (estimated)
Last update
Mar 14, 2008

Study contacts

alp aslan, md
Contact
alpslan@yahoo.com
0905425179917
alp aslan, md
study director · kavaklıdere Umut Hastanesi, Turkey

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.

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