Myocardial Protection in TOF RepairPhase 4TOFNCT02646254

Myocardial Protection and Clinical Outcome in Patients Undergoing Tetralogy of Fallot Repair : A Randomized Study of Two Different Cardioplegia Technique

A Phase 4 study testing blood cardioplegia and del nido cardioplegia in people with Myocardial Protection in TOF Repair, run by SUNDER LAL NEGI.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Myocardial protection and clinical outcome in patients Undergoing tetralogy of fallot repair: a randomized study of Two cardioplegic techniques. Read more about this study

Who is it for?: Ages 1 year to 50 yearsHealthy volunteers can take part
Conditions the study is for: Myocardial Protection in TOF Repair
What is being tested?: blood cardioplegia and del nido cardioplegia
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: No sites listed yet
Study dates: Jun 2014to Oct 2015
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 1 year to 50 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Tetralogy of fallot

Who cannot join

TOF with absent pulmonary valve , TOF with pulmonary atresia

About this study

Official title: MYOCARDIAL PROTECTION AND CLINICAL OUTCOME IN PATIENTS UNDERGOING TETRALOGY OF FALLOT REPAIR: A RANDOMIZED STUDY OF TWO CARDIOPLEGIC TECHNIQUES

Myocardial protection and clinical outcome in patients Undergoing tetralogy of fallot repair: a randomized study of Two cardioplegic techniques.

Read the detailed description

Del Nido cardioplegia has not been used for myocardial protection and clinical outcome in patients undergoing tetralogy of Fallot repair, so the investigators hypothesized that a del Nido cardioplegia technique may be beneficial in the pediatric patients undergoing tetralogy of fallot repair.

Conditions: Myocardial Protection in TOF Repair
Being tested: blood cardioplegia, del nido cardioplegia
Keywords: tetralogy of fallot, cardioplegia
Medical subject headings: Tetralogy of Fallot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

blood cardioplegiaOther
del nido cardioplegiaOther

Study groups in NCT02646254
Study group	Role	What they receive
blood cardioplegia	Active comparator	these patients received blood cardioplegia Receives: Other: blood cardioplegia
del nido cardioplegia	Active comparator	these patients received del nido cardioplegia Receives: Other: del nido cardioplegia

What is being measured

The primary outcome is the main question the study is designed to answer.

inotropic score
Measured: First 24 hours
Creatine kinase MB level baseline preoperative and postoperative 0, 6, 24, and 72 hours
Measured: 72hrs
resumption of spontaneous rhythm after aortic cross clamp off
Measured: 10 minutes

Secondary outcomes (4)

duration of mechanical ventilation in hours
Measured: 48 hours
ICU stay
Measured: 7 days
hospital mortality
Measured: 30 days
echocardiographic assessment
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Oct 2015

First posted5 Jan 2016 (estimated)
Study startJun 2014
Primary completionAug 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Myocardial Protection in TOF RepairStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02646254
Sponsor's protocol ID: NK/1840/DM/16940
Acronym: TOF
Status last verified: Dec 2015
First submitted: 24 Dec 2015
Last updated: 5 Jan 2016
Results posted: No
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MYOCARDIAL PROTECTION AND CLINICAL OUTCOME IN PATIENTS UNDERGOING TETRALOGY OF FALLOT REPAIR: A RANDOMIZED STUDY OF TWO CARDIOPLEGIC TECHNIQUES
ClinicalTrials.gov ID: NCT02646254
Acronym / sponsor ID: TOF / NK/1840/DM/16940
Conditions: Myocardial Protection in TOF Repair
Keywords: tetralogy of fallot, cardioplegia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: SUNDER LAL NEGI
Study start: Jun 2014
Primary completion: Aug 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 5 Jan 2016 (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.

Myocardial protection and clinical outcome in patients Undergoing tetralogy of fallot repair: a randomized study of Two cardioplegic techniques.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
blood cardioplegia	Active comparator	Other: blood cardioplegiathese patients received blood cardioplegia
del nido cardioplegia	Active comparator	Other: del nido cardioplegiathese patients received del nido cardioplegia

Who may qualify

Ages: 1 year to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

Tetralogy of fallot

Key exclusion criteria (1 listed)

TOF with absent pulmonary valve , TOF with pulmonary atresia

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
blood cardioplegia	Other	blood cardioplegia
del nido cardioplegia	Other	del nido cardioplegia

Primary outcome

inotropic score
Time frame: First 24 hours
Creatine kinase MB level baseline preoperative and postoperative 0, 6, 24, and 72 hours
Time frame: 72hrs
resumption of spontaneous rhythm after aortic cross clamp off
Time frame: 10 minutes

4 secondary outcomes

duration of mechanical ventilation in hours
Time frame: 48 hours
ICU stay
Time frame: 7 days
hospital mortality
Time frame: 30 days
echocardiographic assessment
Time frame: 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing blood cardioplegia and del nido cardioplegia in people with Myocardial Protection in TOF Repair, run by SUNDER LAL NEGI.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

inotropic score (time frame: First 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02646254.

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 5 Jan 2016.