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Study of the Corelation Between Circulating Nuclearsome and SIRS Happened After Congential Cardiac Surgery

NCT ID: NCT02325765

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-11-30

Brief Summary

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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

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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

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Congential Cardiac Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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category of RACHS-2 for cardiac surgery

ASD \& VSD repair; VSD repair; Tetralogy repair; Tetralogy repair

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Children's Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wei Wang, MD

Role: STUDY_DIRECTOR

Shanghai Children's Medical Center

Locations

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Shanghai Children's Medical Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 27357468 (View on PubMed)

Other Identifiers

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EY05.055

Identifier Type: -

Identifier Source: org_study_id