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

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

    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Shanghai Children's Medical Center

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
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 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
preoperation to 72 hours after congential cardiac surgery

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
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

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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