NCT01773720

Brief Summary

The aim of our study was to evaluate the reliability of uncalibrated cardiac index monitoring based on arterial waveform analysis in patients undergoing off-pump coronary artery bypass grafting.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

1.4 years

First QC Date

January 15, 2013

Last Update Submit

January 18, 2013

Conditions

Cardiac Index

Keywords

cardiac indexcoronary artery bypassuncalibrated pulse contour analysishemodynamic monitoring

Outcome Measures

Primary Outcomes (1)

  • Validity of cardiac index measurement

    Accuracy and precision of cardiac index measurement using uncalibrated pulse contour analysis in comparison with transpulmonary thermodilution

    Up to 24 hrs post surgery

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with coronary artery disease, ranked ASA II-III and scheduled for elective off-pump coronary artery bypass grafting

You may qualify if:

  • elective off-pump coronary artery bypass grafting

You may not qualify if:

  • age \< 18 and \> 80 years,
  • preoperative ejection fraction \< 0.35,
  • severe cardiac valve dysfunction or peripheral vascular disease,
  • constant atrial fibrillation,
  • simultaneous interventions (carotid endarterectomy, aneurysm repair, etc.),
  • transfer to cardiopulmonary bypass.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Anesthesiology, Northern SMU

Arkhangelsk, 163000, Russia

RECRUITING

Related Publications (1)

  • Smetkin AA, Hussain A, Kuzkov VV, Bjertnaes LJ, Kirov MY. Validation of cardiac output monitoring based on uncalibrated pulse contour analysis vs transpulmonary thermodilution during off-pump coronary artery bypass grafting. Br J Anaesth. 2014 Jun;112(6):1024-31. doi: 10.1093/bja/aet489. Epub 2014 Feb 13.

    PMID: 24531685DERIVED

Biospecimen

Retention: NONE RETAINED

No biospecimens are to be retained.

Study Officials

  • Mikhail Y Kirov, MD, PhD

    Northern State Medical Univercity

    STUDY DIRECTOR

Central Study Contacts

Mikhail Y Kirov, MD, PhD

CONTACT

+7-8182-63-27-30mikhail_kirov@hotmail.com

Study Design

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

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 23, 2013

Study Start

October 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

RU(1)