NitroprussidePhase 4NCT00636584
Clinical Study Investigating the Effect of Sodium Nitroprusside Infusion on Thyroidal Function
A Phase 4 study testing sodium nitroprusside in people with Nitroprusside and Thyroid Hormones, run by Kavaklıdere Umut Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Nitroprusside, Thyroid Hormones
- What is being tested?
- sodium nitroprusside
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2008to Mar 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients without history of:
- thyroidal disease
- hypertension
- pulmonary disease
- peripheral vascular disease
- stroke
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- recent myocardial infarction within the week prior to operation
- unstable angina pectoris
- liver or kidney dysfunction
- morbid obesity
- cachexia
- sulfonylurea intake
Who cannot join
- 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
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- non-steroidal anti-inflammatory agents
- steroids
- estrogens
- antacids
- diphenylhydantoin
- spironolactone
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kavaklıdere Umut Hastanesi
Ankara, 06660
Alp Aslan, MD, 0905425179917, alpslan@yahoo.com
Selen Osmanağaoğlu, MD, 0905324675969, sosmanaga@gmail.com
About this study
Official title: Does Sodium Nitroprusside Infusion Affect Thyroidal Function in Patients Undergoing Coronary Artery Bypass Grafting, a Prospective Randomized Clinical Trial.
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.
- Conditions
- Nitroprusside, Thyroid Hormones
- Being tested
- sodium nitroprusside, placebo
- Keywords
- sodium nitroprusside, thyroid hormones, thoracic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium nitroprussideDrug
Also called nipruss
sodium nitroprusside infusion at 1 microgram/kg/min dose during rewarming period of cardiac operations
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | arm1: sodium nitroprusside group Receives: Drug: sodium nitroprusside |
| 2 | Placebo comparator | arm2: control group,saline infused instead of sodium nitroprusside Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
free T3
Measured: on admission, prior to operation, at the beginning of CPB, following CPB, at first, third and fifth postoperative days
Secondary outcomes (1)
total T3
Measured: on admission, prior to operation, at the beginning of CPB, following CPB, on the first, third and fifth postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2008
- Study completionMar 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NitroprussideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kavaklıdere Umut Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara University
- Investigators
- alp aslan, md, Study director, kavaklıdere Umut Hastanesi, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636584
- Sponsor's protocol ID
- 2008-0048
- Status last verified
- Mar 2008
- First submitted
- 7 Mar 2008
- Last updated
- 14 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Sodium Nitroprusside Infusion Affect Thyroidal Function in Patients Undergoing Coronary Artery Bypass Grafting, a Prospective Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT00636584
- Acronym / sponsor ID
- 2008-0048
- Conditions
- Nitroprusside, Thyroid Hormones
- Keywords
- sodium nitroprusside, thyroid hormones, thoracic surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Kavaklıdere Umut HospitalUniversity, hospital or other
- Collaborators
- Ankara University
- Study start
- Feb 2008
- Primary completion
- Feb 2008 (actual)
- Study completion
- Mar 2008 (estimated)
- First posted
- 14 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: sodium nitroprussidearm1: sodium nitroprusside group |
| 2 | Placebo comparator | Drug: placeboarm2: control group,saline infused instead of sodium nitroprusside |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- thyroidal disease
- hypertension
- pulmonary disease
- peripheral vascular disease
- stroke
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sodium nitroprussideAlso: niprusssodium nitroprusside infusion at 1 microgram/kg/min dose during rewarming period of cardiac operations | Drug | 1 |
| placeboplacebo | Drug | 2 |
Primary outcome
free T3
Time frame: on admission, prior to operation, at the beginning of CPB, following CPB, at first, third and fifth postoperative days
1 secondary outcome
total T3
Time frame: on admission, prior to operation, at the beginning of CPB, following CPB, on the first, third and fifth postoperative days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2008.
- home page of kavaklidere umut hospitalLink provided by the sponsor.
Related trials for Nitroprusside
RecruitingObservational study
The FOCUS-ADHF Registry
Acute Heart Failure With Reduced Ejection Fraction, Decompensation; Heart, Congestive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
alp aslan, md study director
kavaklıdere Umut Hastanesi, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sodium nitroprusside in people with Nitroprusside and Thyroid Hormones, run by Kavaklıdere Umut Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact alp aslan, md (0905425179917, alpslan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
free T3 (time frame: on admission, prior to operation, at the beginning of CPB, following CPB, at first, third and fifth postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2008.