Registry for Perioperative Data in Patients Undergoing Cardiac Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Yunseok Jeon, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01713192
First received: October 22, 2012
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

The purpose of this registry is to obtain perioperative data in patients undergoing cardiac surgery and find out relations between the data and investigate several causes affecting postoperative complications.


Condition
Cardiac Surgical Procedures
Anesthesia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • perioperative data [ Time Frame: 1 year after surgery ] [ Designated as safety issue: Yes ]

    To obtain the perioperative data in patients undergoing cardiac surgery. Data will be collected including demographics, surgery and postoperative complications.

    In addition, laboratory data such as coagulation and cytokine will be obtained. Intraoperative monitoring including bispectral index, cerebral oximeter, tissue oxygen saturation [InspectraTM StO2 (Hutchinson Technology Inc., MN, USA)], cardiac index [FloTrac/EV1000 (Edwards Lifesciences, Irvine, CA, USA), VolumeView/EV1000 (Edwards Lifesciences, Irvine, CA, USA), Vigilance II (Edwards Lifesciences, Irvine, CA, USA)] and mixed venous oxygen saturation will be evaluated.



Estimated Enrollment: 200
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cardiac surgery

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing cardiac surgery

Criteria

Inclusion Criteria:

  • patients undergoing cardiac surgery

Exclusion Criteria:

  • refused to participate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01713192

Contacts
Contact: Yunseok Jeon, PhD 82-2-2072-2467 jeonyunseok@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Yunseok Jeon, PhD    82-2072-2467    jeonyunseok@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Yunseok Jeon, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01713192     History of Changes
Other Study ID Numbers: YSJeon_Registry
Study First Received: October 22, 2012
Last Updated: June 9, 2014
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on July 22, 2014