Inflammatory Genetic Polymorphism and Acute Lung Injury After Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jia-feng Wang, Changhai Hospital
ClinicalTrials.gov Identifier:
NCT00826072
First received: January 20, 2009
Last updated: May 2, 2013
Last verified: May 2013
  Purpose

Acute lung injury is a common complication of cardiac surgery with cardiopulmonary bypass, and it is significantly related to prolonged postoperative recovery, hospital stays and medical cost. Currently available predictors of acute lung injury after cardiac surgery are still limited within clinical data. Several genetic polymorphism of inflammatory mediators have been reported to be associated with severity of sepsis and ARDS, but the association of these inflammatory polymorphism and acute lung injury after cardiac surgery has never been reported. This study is performed to investigate the association of genetic polymorphisms including TNF -308A/G, IL-10 -1082A/G and IL-6 -572C/G and postoperative lung injury.


Condition
Acute Lung Injury

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Association Study of Inflammatory Genetic Polymorphism and Acute Lung Injury After Cardiac Surgery With Cardiopulmonary Bypass

Resource links provided by NLM:


Further study details as provided by Changhai Hospital:

Primary Outcome Measures:
  • Acute lung injury after cardiac surgery with cardiopulmonary bypass [ Time Frame: 24h after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • circulating level of CRP, TNF-alpha, IL-10, IL-6; APACHE Ⅱ score; postoperative kidney injury, duration of ventilation, ICU stay and hospitalization; death in 28 days [ Time Frame: 24h and 1 month after surgery ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

3ml blood before surgery, after surgery and 24h after surgery respectively


Enrollment: 107
Study Start Date: May 2008
Study Completion Date: January 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
ALI
patients with acute lung injury at 24h after cardiac surgery
Control
patients without acute lung injury 24h after cardiac surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Unrelated Chinese Han patients undergoing elective cardiac surgery with CPB

Criteria

Inclusion Criteria:

  • Chinese Han unrelated population
  • adult patients
  • undergoing elective cardiac surgery with CPB

Exclusion Criteria:

  • malignant tumor
  • autoimmune disease, immunodeficiency or immunosuppressive therapy
  • chronic renal disease (glomerular filtration rate < 60ml/(min•1.73m2)) or liver dysfunction (Child Pugh classification>A)
  • COPD, tuberculosis or other chronic pulmonary diseases
  • anemia with hemoglobin lower than 90mmHg
  • bleeding disorders
  • postoperative pericardial tamponade requiring re-operation
  • postoperative low cardiac output syndrome or acute pulmonary edema after left cardiac failure.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00826072

Locations
China
Changhai Hospital, Second Military Medical University
Shanghai, China, 200433
Sponsors and Collaborators
Changhai Hospital
  More Information

Publications:
Responsible Party: Jia-feng Wang, M.D., Changhai Hospital
ClinicalTrials.gov Identifier: NCT00826072     History of Changes
Other Study ID Numbers: PCSP-inflammation
Study First Received: January 20, 2009
Last Updated: May 2, 2013
Health Authority: China: Ethics Committee

Keywords provided by Changhai Hospital:
Single Nucleotide Polymorphism
cardiopulmonary bypass
cardiac surgery

Additional relevant MeSH terms:
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Lung Injury
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Thoracic Injuries

ClinicalTrials.gov processed this record on July 22, 2014