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NCT01713192 Clinical Trial

Registry for Perioperative Data in Patients Undergoing Cardiac Surgery

Anesthesia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01713192
Other study ID # YSJeon_Registry
Secondary ID
Status Completed
Phase N/A
First received October 22, 2012
Last updated November 16, 2015
Start date January 2013
Est. completion date September 2014

Study information
Verified date November 2015
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- patients undergoing cardiac surgery

Exclusion Criteria:

- refused to participate

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary perioperative data 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.		 1 year after surgery Yes
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