NCT00745810

Brief Summary

Ischemia- reperfusion ( IR ) injuries were not only seen in the transplanted organs but also the remote organs such as lungs that brings major postoperative complications. Severe complications such as pulmonary infiltration and pulmonary edema following reperfusion were frequently associated with liver transplantation. Cardiac surgery performed with the use of cardiopulmonary bypass ( CPB ) provokes a systemic inflammatory response syndrome that affects postoperative pulmonary, myocardiac and renal functions. Previous study about the reperfusion injuries was focused on the leukocyte and endothelial activation and the following oxidative injuries, however, the alteration on pulmonary function such as dynamic compliance and the oxidative/antioxidative balance in erythrocytes and the following effects in CPB have not been fully studied. Erythrocytes' reaction to oxidative stress including cytoplasma and cell membrane should be studied because RBCs are the major circulating blood cells having different types of antioxidant system to capture reactive oxygen species ( ROS ) thus RBC may be severely injured by ROS or protected ROS injuries during CPB. In these three-year study, we plan to explore the extent and pattern of remote oxidative injuries in lungs by massive ROS production and the following products released from reperfused organs. In the first year, the remote pulmonary injuries from hepatic IR will be focused. We plan to establish an animal model for pulmonary function and pulmonary injury assessments including dynamic compliance (Cdyn), pulmonary edema wet-to-dry ratio (W/D), malondialdehyde (MDA) and histopathological findings under hepatic IR challenge. In the second year, the IR effects during and after CPB on circulating blood cells will be fully studied. We plan to investigate the magnitude, subtypes and timing on ROS production, the changes of oxidative and antioxidant activities of erythrocytes including cytoplasma and cell membrane, the changes on leukocytes and plasma to explore the roles of circulating erythrocytes on oxidative stress in CPB. In the third year, we plan to try propofol, stated having antioxidant in vivo and in vitro, on the remote pulmonary injuries following hepatic IR and CPB.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

October 17, 2011

Status Verified

June 1, 2011

Enrollment Period

2.3 years

First QC Date

August 31, 2008

Last Update Submit

October 13, 2011

Conditions

Keywords

cardiopulmonary bypassoxidative injuries

Study Arms (1)

1

sequential changes before and after cardiopulmonary bypass including ROS, antioxidant status, leukocyte elastase, complements, inflammatory cytokines

Other: Cardiopulmonary bypass

Interventions

sequential changes of oxidative injuries before and after cardiopulmonary bypass

Also known as: oxidative injuries, inflammatory cytokines, complements, leukocyte elastase
1

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who receive an open heart surgery under cardiopulmonary bypass

You may qualify if:

  • age \> 20 y/0, need cardiopulmonary bypass

You may not qualify if:

  • severe anemia, hematologic diseases, hormone therapy, previous valvular surgery, blood transfusion in recent 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei, 100, Taiwan

Location

Biospecimen

Retention: NONE RETAINED

whole blood and plasma

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

Cardiopulmonary BypassOxidative StressComplement System ProteinsLeukocyte Elastase

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Extracorporeal CirculationSurgical Procedures, OperativeMetabolismStress, PhysiologicalPhysiological PhenomenaImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsPancreatic ElastaseSerine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine Proteases

Study Officials

  • ya-jung cheng, PhD

    Department of anesthesia, national taiwan university hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2008

First Posted

September 3, 2008

Study Start

August 1, 2008

Primary Completion

November 1, 2010

Study Completion

December 1, 2010

Last Updated

October 17, 2011

Record last verified: 2011-06

Locations