Congenital Heart DiseasesNCT01450956
The Protective Effects of Sevoflurane in Pediatric Cardiac Surgery
A study testing Sevoflurane in people with Congenital Heart Diseases, run by Xijing Hospital at 1 site in China.
Trial summary
During repair of a congenital heart defect the child is exposed to myocardial hypoxia. Recent studies have suggested that the paediatric myocardium is more sensitive to hypoxia and cardioplegic arrest than the adult. Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- Congenital Heart Diseases
- What is being tested?
- Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Sep 2011to Jan 2012
- Phase
- Interventional
- 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 month to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- pediatric patients (body weight < 10 kg)
- diagnosed with congenital heart diseases
- scheduled for repair operation with CPB
- in the Department of Cardiovascular Surgery, Xijing Hospital
Who cannot join
- systemic infections
- other systemic diseases
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Cardiovascular Surgery, Xijing Hospital
Xi'an, Shaanxi, 710032
Zhenxiao Jin, PhD, 86-29-84771022, jinzx10262@yahoo.com.cn
Hongyan Xiong, MD
About this study
Official title: The Protective Effects of Sevoflurane Application During CPB on Pediatric Patients Underwent Cardiac Surgery: a Randomized, Controlled, Blinded Clinical Trial
During repair of a congenital heart defect the child is exposed to myocardial hypoxia. Recent studies have suggested that the paediatric myocardium is more sensitive to hypoxia and cardioplegic arrest than the adult. The protective effect of halogenated agents on ischaemia and reperfusion injury has been investigated widely in adults. The investigators hypothesis that sevoflurane applied during cardiopulmonary bypass might afford better myocardial protection during paediatric cardiac surgery.
- Conditions
- Congenital Heart Diseases
- Being tested
- Sevoflurane, Control
- Keywords
- congenital heart diseases, cardiopulmonary bypass, Pediatric, sevoflurane
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Sevoflurane will be given at a concentration of 2% through oxygenator during CPB
ControlOther
Patients will receive only oxygen and air through oxygenator
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Experimental | Patients will receive 2% sevoflurane via oxygenator during CPB Receives: Drug: Sevoflurane |
| Control | No intervention | Patients will receive only oxygen and air through oxygenator Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
All cause mortality after the cardaic surgery, patients will be followed up for 30 days
Measured: within the first 30 days (plus or minus 3 days) after surgery
Secondary outcomes (1)
serum cTnI concentrations
serial serum cTnI concentrations will be determined to whether sevoflurane application during CPB will decrease the cTnI release after operation.
Measured: 48 h after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionJan 2012 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseasesStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhenxiao Jin, PhD, Principal investigator, Department of Cardiovascular Surgery, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450956
- Sponsor's protocol ID
- XJXZ2011-010
- Status last verified
- Nov 2011
- First submitted
- 7 Oct 2011
- Last updated
- 28 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xiong HY, Liu Y, Shu DC, Zhang SL, Qian X, Duan WX, Cheng L, Yu SQ, Jin ZX. Effects of Sevoflurane Inhalation During Cardiopulmonary Bypass on Pediatric Patients: A Randomized Controlled Clinical Trial. ASAIO J. 2016 Jan-Feb;62(1):63-8. doi: 10.1097/MAT.0000000000000285.
PubMed 26418205
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Protective Effects of Sevoflurane Application During CPB on Pediatric Patients Underwent Cardiac Surgery: a Randomized, Controlled, Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT01450956
- Acronym / sponsor ID
- XJXZ2011-010
- Conditions
- Congenital Heart Diseases
- Keywords
- congenital heart diseases, cardiopulmonary bypass, Pediatric, sevoflurane
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 13 Oct 2011 (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.
During repair of a congenital heart defect the child is exposed to myocardial hypoxia. Recent studies have suggested that the paediatric myocardium is more sensitive to hypoxia and cardioplegic arrest than the adult. The protective effect of halogenated agents on ischaemia and reperfusion injury has been investigated widely in adults. The investigators hypothesis that sevoflurane applied during cardiopulmonary bypass might afford better myocardial protection during paediatric cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Experimental | Drug: SevofluranePatients will receive 2% sevoflurane via oxygenator during CPB |
| Control | No intervention | Other: ControlPatients will receive only oxygen and air through oxygenator |
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- pediatric patients (body weight < 10 kg)
- diagnosed with congenital heart diseases
- scheduled for repair operation with CPB
- in the Department of Cardiovascular Surgery, Xijing Hospital
Key exclusion criteria (2 listed)
- systemic infections
- other systemic diseases
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 |
|---|---|---|
| SevofluraneSevoflurane will be given at a concentration of 2% through oxygenator during CPB | Drug | Sevoflurane |
| ControlPatients will receive only oxygen and air through oxygenator | Other | Control |
Primary outcome
all cause mortality
Time frame: within the first 30 days (plus or minus 3 days) after surgery
All cause mortality after the cardaic surgery, patients will be followed up for 30 days
1 secondary outcome
serum cTnI concentrations
Time frame: 48 h after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2011.
- Derived from this study: PubMed 26418205Xiong HY, Liu Y, Shu DC, Zhang SL, Qian X, Duan WX, Cheng L, Yu SQ, Jin ZX. Effects of Sevoflurane Inhalation During Cardiopulmonary Bypass on Pediatric Patients: A Randomized Controlled Clinical Trial. ASAIO J. 2016 Jan-Feb;62(1):63-8. doi: 10.1097/MAT.0000000000000285.
Related trials for Congenital Heart Diseases
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
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.
Zhenxiao Jin, PhD principal investigator
Department of Cardiovascular Surgery, Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane in people with Congenital Heart Diseases, run by Xijing Hospital at 1 site in China.
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 4 inclusion and 2 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 28 Nov 2011. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhenxiao Jin, Ph.D (86-29-84771022, jinzx10262@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: within the first 30 days (plus or minus 3 days) after surgery). 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 NCT01450956, which also lists 1 linked publication.
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 28 Nov 2011.