Congenital DisordersNCT00268099
Optimal Timing for Repair of Right-to-Left Shunt Lesions
An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial summary
The primary aim of this study is to determine the optimal timing for repair of right-to-left shunt lesions such as Tetralogy of Fallot defects. The secondary aim being define the criteria for failing medical therapy. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Congenital Disorders
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Nov 2006
- Phase
- Observational
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients in the congenital surgery database who have undergone repair of a Tetralogy of Fallot defect
Who may be able to join
- patients in the congenital surgery database who have undergone repair of a Tetralogy of Fallot defect
Who cannot join
- those who do not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
The primary aim of this study is to determine the optimal timing for repair of right-to-left shunt lesions such as Tetralogy of Fallot defects.
The secondary aim being define the criteria for failing medical therapy.
Read the detailed description
In the past, children with right-to-left shunt lesions such as Tetralogy of Fallot defects were palliated with a systemic to pulmonary artery shunt. This prevented cyanosis while the child grew to a size where complete repair could be undertaken. With the improvements in surgical technique and critical care, there is a push to do a primary complete repair for these defects at younger and younger ages. These operations should be delayed as long as possible to allow for growth but not so long that there is unnecessary cyanosis and hypoxemia.
Study Design and Methodology:
Retrospective chart review - approximately 75 patients
Preoperative data:
Diagnosis
Operative data:
Age and weight at surgery Type of surgical procedure Whether pulmonary valve is spared
Postoperative data:
Length of time on ventilator Length of time on inotropes Length of ICU stay Length of hospital stay Complications
- Conditions
- Congenital Disorders
- Keywords
- pediatric, cardiac, repair of right to left shunt lesions, Tetralogy of Fallot defects
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2005 (estimated)
- Study startMay 2005
- Study completionNov 2006
Why it stopped: study not started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital DisordersStudies 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Investigators
- Brian E Kogon, MD, Principal investigator, Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00268099
- Sponsor's protocol ID
- 05-121
- Status last verified
- Jun 2007
- First submitted
- 20 Dec 2005
- Last updated
- 16 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Timing for Repair of Right-to-Left Shunt Lesions
- ClinicalTrials.gov ID
- NCT00268099
- Acronym / sponsor ID
- 05-121
- Conditions
- Congenital Disorders
- Keywords
- pediatric, cardiac, repair of right to left shunt lesions, Tetralogy of Fallot defects
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: study not started
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- May 2005
- Study completion
- Nov 2006 (actual)
- First posted
- 22 Dec 2005 (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.
The primary aim of this study is to determine the optimal timing for repair of right-to-left shunt lesions such as Tetralogy of Fallot defects.
The secondary aim being define the criteria for failing medical therapy.
Detailed description
In the past, children with right-to-left shunt lesions such as Tetralogy of Fallot defects were palliated with a systemic to pulmonary artery shunt. This prevented cyanosis while the child grew to a size where complete repair could be undertaken. With the improvements in surgical technique and critical care, there is a push to do a primary complete repair for these defects at younger and younger ages. These operations should be delayed as long as possible to allow for growth but not so long that there is unnecessary cyanosis and hypoxemia.
Study Design and Methodology:
Retrospective chart review - approximately 75 patients
Preoperative data:
Diagnosis
Operative data:
Age and weight at surgery Type of surgical procedure Whether pulmonary valve is spared
Postoperative data:
Length of time on ventilator Length of time on inotropes Length of ICU stay Length of hospital stay Complications
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients in the congenital surgery database who have undergone repair of a Tetralogy of Fallot defect
Key inclusion criteria (1 listed)
- patients in the congenital surgery database who have undergone repair of a Tetralogy of Fallot defect
Key exclusion criteria (1 listed)
- those who do not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: study not started). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2012.
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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.
Brian E Kogon, MD principal investigator
Children's Healthcare of Atlanta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.
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: stopped early, as of the sponsor's last update on 16 Mar 2012. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: study not started). Results are not available in the source record.
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.
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 16 Mar 2012.