Congential Cardiac SurgeryNCT02325765
Study of the Corelation Between Circulating Nuclearsome and SIRS Happened After Congential Cardiac Surgery
An observational study of Congential Cardiac Surgery, run by Shanghai Children's Medical Center at 1 site in China.
Trial summary
In this study，the investigators want to determine the corelation between circulating nuclearsome and the development of SIRS occured after congenital cardiac surgery, including the serverity of organ damage and inflamation. Read more about this study
- Who is it for?
- Ages 1 month to 3 years
- Conditions the study is for
- Congential Cardiac Surgery
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Apr 2014to Nov 2015
- 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 1 month to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: 1-36 months 2.5-15 kilogram accepted congential cardiac surgery
Who may be able to join
- children with congenial heart disease
Who cannot join
- Less than 2.5kg
- Prematurity less than 37 weeks estimated gestational age
- Renal failure as described by the pediatric RIFLE criteria
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, 200127
About this study
Official title: Corelation Between Circulating Nuclearsome and SIRS Happened After Congential Cardiac Surgery
In this study，the investigators want to determine the corelation between circulating nuclearsome and the development of SIRS occured after congenital cardiac surgery, including the serverity of organ damage and inflamation.
Read the detailed description
Blood was collected from study participants at 6 time points; 1) post-anesthesia induction, 2) post-op hour 0, 3) post-op hour 4, 4) post-op hour 24, 5) post-op hour 48, and 6) post-op hour 72. At each of the 6 time points blood was analyzed for levels of the following:histone,blood routine test , c-reaction protein, procalcitonin, N-terminal pro-brain natriuretic,the hepatorenal function，cardiac function and pulmonary function
- Conditions
- Congential Cardiac Surgery
- Keywords
- congential cardiac surgery, nuclearsome, systemic inflammation response syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| category of RACHS-2 for cardiac surgery | ASD \& VSD repair; VSD repair; Tetralogy repair; Tetralogy repair | |
| category of RACHS-3 for cardiac surgery | DORV repair with or without RV obstruction; AVSD (complete or transitional) repair with or without valve replacement; Coarctation \& VSD repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
the perioperation change of histone level
Measured: preoperation to 72 hours after congential cardiac surgery
Secondary outcomes (3)
the perioperation change of c-reaction protein level
Measured: preoperation to 72 hours after congential cardiac surgery
the perioperation change of cardiac function
Measured: preoperation to 72 hours after congential cardiac surgery
the perioperation change of blood routine test
Measured: preoperation to 72 hours after congential cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2015
- Study completionNov 2015
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 Congential Cardiac SurgeryStudies 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Wang, MD, Study director, Shanghai Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325765
- Sponsor's protocol ID
- EY05.055
- Status last verified
- Nov 2015
- First submitted
- 16 Dec 2014
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gao H, Zhang N, Lu F, Yu X, Zhu L, Mo X, Wang W. Circulating histones for predicting prognosis after cardiac surgery: a prospective study. Interact Cardiovasc Thorac Surg. 2016 Nov;23(5):681-687. doi: 10.1093/icvts/ivw198. Epub 2016 Jun 29.
PubMed 27357468
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corelation Between Circulating Nuclearsome and SIRS Happened After Congential Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02325765
- Acronym / sponsor ID
- EY05.055
- Conditions
- Congential Cardiac Surgery
- Keywords
- congential cardiac surgery, nuclearsome, systemic inflammation response syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Shanghai Children's Medical CenterUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 25 Dec 2014 (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.
In this study，the investigators want to determine the corelation between circulating nuclearsome and the development of SIRS occured after congenital cardiac surgery, including the serverity of organ damage and inflamation.
Detailed description
Blood was collected from study participants at 6 time points; 1) post-anesthesia induction, 2) post-op hour 0, 3) post-op hour 4, 4) post-op hour 24, 5) post-op hour 48, and 6) post-op hour 72. At each of the 6 time points blood was analyzed for levels of the following:histone,blood routine test , c-reaction protein, procalcitonin, N-terminal pro-brain natriuretic,the hepatorenal function，cardiac function and pulmonary function
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| category of RACHS-2 for cardiac surgery | – | –ASD \& VSD repair; VSD repair; Tetralogy repair; Tetralogy repair |
| category of RACHS-3 for cardiac surgery | – | –DORV repair with or without RV obstruction; AVSD (complete or transitional) repair with or without valve replacement; Coarctation \& VSD repair |
Who may qualify
- Ages
- 1 month to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 1-36 months 2.5-15 kilogram accepted congential cardiac surgery
Key inclusion criteria (1 listed)
- children with congenial heart disease
Key exclusion criteria (3 listed)
- Less than 2.5kg
- Prematurity less than 37 weeks estimated gestational age
- Renal failure as described by the pediatric RIFLE 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
the perioperation change of histone level
Time frame: preoperation to 72 hours after congential cardiac surgery
3 secondary outcomes
the perioperation change of c-reaction protein level
Time frame: preoperation to 72 hours after congential cardiac surgery
the perioperation change of cardiac function
Time frame: preoperation to 72 hours after congential cardiac surgery
the perioperation change of blood routine test
Time frame: preoperation to 72 hours after congential cardiac surgery
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 2 Dec 2015.
- Derived from this study: PubMed 27357468Gao H, Zhang N, Lu F, Yu X, Zhu L, Mo X, Wang W. Circulating histones for predicting prognosis after cardiac surgery: a prospective study. Interact Cardiovasc Thorac Surg. 2016 Nov;23(5):681-687. doi: 10.1093/icvts/ivw198. Epub 2016 Jun 29.
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.
Wei Wang, MD study director
Shanghai Children's Medical Center
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 Congential Cardiac Surgery, run by Shanghai Children's Medical Center 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 1 inclusion and 3 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 2 Dec 2015. 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?
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?
the perioperation change of histone level (time frame: preoperation to 72 hours after congential cardiac 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 NCT02325765, 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 2 Dec 2015.