NCT00624494

Brief Summary

The aim of the present study was to evaluate the usefulness of an algorithm based on hemodynamic parameters obtained by single transpulmonary thermodilution (STD) combined with continuous monitoring of central venous oxygen saturation (ScvO2) for perioperative management of patients undergoing OPCAB.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started May 2005

Typical duration for not_applicable coronary-artery-disease

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

Study Start

First participant enrolled

May 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 27, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

3.3 years

First QC Date

February 13, 2008

Last Update Submit

March 20, 2024

Conditions

Keywords

venous oxygen saturationtranspulmonary thermodilution

Outcome Measures

Primary Outcomes (1)

  • length of hospital stay

    Length of the hospital stays, Days

    one month

Study Arms (2)

Conventional monitoring

ACTIVE COMPARATOR

hemodynamic monitoring - conventional monitoring

Device: Conventional monitoring

Advanced monitoring

ACTIVE COMPARATOR

hemodynamic monitoring - advanced monitoring

Device: Advanced monitoring

Interventions

In the CM group, therapy was guided by central venous pressure, mean arterial pressure (MAP) and heart rate (HR)

Also known as: Non actual
Conventional monitoring

In the AM group by the intrathoracic blood volume index, MAP, HR, central venous oxygen saturation (ScvO2) and cardiac index (CI). The measurements were performed before and during surgery, and at 2, 4 and 6 hrs post-operatively.

Also known as: PiCCO-CeVOX
Advanced monitoring

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with coronary artery disease, ranked ASA II-III and scheduled for elective OPCAB

You may not qualify if:

  • Age \< 18 years
  • Severe valve dysfunction or peripheral vascular disease
  • Simultaneous interventions (carotid endarterectomy, aneurysm repair, etc.)
  • Transfer to CPB during surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Anesthesiology, Northern SMU

Arkhangelsk, 163000, Russia

Location

Related Publications (1)

  • Smetkin AA, Kirov MY, Kuzkov VV, Lenkin AI, Eremeev AV, Slastilin VY, Borodin VV, Bjertnaes LJ. Single transpulmonary thermodilution and continuous monitoring of central venous oxygen saturation during off-pump coronary surgery. Acta Anaesthesiol Scand. 2009 Apr;53(4):505-14. doi: 10.1111/j.1399-6576.2008.01855.x. Epub 2009 Jan 15.

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Mikhail Y Kirov

    Northern SMU

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. M.Y. Kirov, MD, PhD

Study Record Dates

First Submitted

February 13, 2008

First Posted

February 27, 2008

Study Start

May 1, 2005

Primary Completion

August 1, 2008

Study Completion

September 1, 2008

Last Updated

March 22, 2024

Record last verified: 2024-03

Locations