- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02325765
Study of the Corelation Between Circulating Nuclearsome and SIRS Happened After Congential Cardiac Surgery
November 28, 2015 updated by: Shanghai Children's Medical Center
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Shanghai
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Shanghai, Shanghai, China, 200127
- Shanghai Children's Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 3 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
1-36 months 2.5-15 kilogram accepted congential cardiac surgery
Description
Inclusion Criteria:
- children with congenial heart disease
Exclusion Criteria:
- Less than 2.5kg
- Prematurity less than 37 weeks estimated gestational age
- Renal failure as described by the pediatric RIFLE criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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category of RACHS-2 for cardiac surgery
ASD & VSD repair; VSD repair; Tetralogy repair; Tetralogy repair
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the perioperation change of histone level
Time Frame: preoperation to 72 hours after congential cardiac surgery
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preoperation to 72 hours after congential cardiac surgery
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the perioperation change of c-reaction protein level
Time Frame: preoperation to 72 hours after congential cardiac surgery
|
preoperation to 72 hours after congential cardiac surgery
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the perioperation change of cardiac function
Time Frame: preoperation to 72 hours after congential cardiac surgery
|
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
|
preoperation to 72 hours after congential cardiac surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Wei Wang, MD, Shanghai Children's Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
December 16, 2014
First Submitted That Met QC Criteria
December 21, 2014
First Posted (Estimate)
December 25, 2014
Study Record Updates
Last Update Posted (Estimate)
December 2, 2015
Last Update Submitted That Met QC Criteria
November 28, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- EY05.055
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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