Clinical Study Investigating the Effect of Sodium Nitropr... | NCT00636584

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

NCT00636584

Sponsor

Kavaklıdere Umut Hospital

Status

Unknown status

Last Update Posted

Mar 14, 2008Estimated

Enrollment

106Estimated

Phase

Phase 4

Conditions

Nitroprusside
Thyroid Hormones

Interventions

sodium nitroprusside
placebo

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Feb 2008Actual

Completion Date

Mar 2008Estimated

First Submitted Date

Mar 7, 2008

First Submission Date that Met QC Criteria

Mar 7, 2008

First Posted Date

Mar 14, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2008

Last Update Posted Date

Mar 14, 2008Estimated

Name	Class
Ankara University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

106Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	arm1: sodium nitroprusside group	Drug: sodium nitroprusside
2	Placebo Comparator	arm2: control group,saline infused instead of sodium nitroprusside	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sodium nitroprusside	Drug	sodium nitroprusside infusion at 1 microgram/kg/min dose during rewarming period of cardiac operations	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
free T3		on admission, prior to operation, at the beginning of CPB, following CPB, at first, third and fifth postoperative days

Secondary Outcomes

Measure	Description	Time Frame
total T3		on admission, prior to operation, at the beginning of CPB, following CPB, on the first, third and fifth postoperative days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
alp aslan, md	Contact	0905425179917		alpslan@yahoo.com

Overall Officials

Name	Affiliation	Role
alp aslan, md	kavaklıdere Umut Hastanesi, Turkey	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kavaklıdere Umut Hastanesi	Recruiting	Ankara		06660	Turkey (Türkiye)

Label	URL
home page of kavaklidere umut hospital	View source

Type	Date	Date Unknown
Release	Dec 15, 2008
Unrelease		Yes
Release	Dec 17, 2008
Reset	Jan 21, 2009

Intervention Browse Module

MeSH Terms

ID	Term
D009599	Nitroprusside

Ancestor Terms

ID	Term
D005292	Ferricyanides
D003486	Cyanides
D000838	Anions
D007477	Ions
D004573

Browse Leaves

Not provided

Browse Branches

Not provided

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Dec 15, 2008		Yes
Dec 17, 2008