NCT01713192

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 18, 2015

Status Verified

November 1, 2015

Enrollment Period

1.7 years

First QC Date

October 22, 2012

Last Update Submit

November 16, 2015

Conditions

Cardiac Surgical ProceduresAnesthesia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Cardiac surgery

Eligibility Criteria

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

Patients undergoing cardiac surgery

You may qualify if:

  • patients undergoing cardiac surgery

You may not qualify if:

  • refused to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (2)

  • Cho YJ, Koo CH, Kim TK, Hong DM, Jeon Y. Comparison of cardiac output measures by transpulmonary thermodilution, pulse contour analysis, and pulmonary artery thermodilution during off-pump coronary artery bypass surgery: a subgroup analysis of the cardiovascular anaesthesia registry at a single tertiary centre. J Clin Monit Comput. 2016 Dec;30(6):771-782. doi: 10.1007/s10877-015-9784-6. Epub 2015 Oct 1.

    PMID: 26429135DERIVED

  • Kim TK, Cho YJ, Min JJ, Murkin JM, Bahk JH, Hong DM, Jeon Y. Microvascular reactivity and clinical outcomes in cardiac surgery. Crit Care. 2015 Sep 4;19(1):316. doi: 10.1186/s13054-015-1025-3.

    PMID: 26337035DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 22, 2012

First Posted

October 24, 2012

Study Start

January 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

November 18, 2015

Record last verified: 2015-11

Locations

KR(1)