Single Transpulmonary Thermodilution and Continuous Monitoring of Central Venous Oxygen Saturation During Off-pump Coronary Surgery (OPCAB)

This study has been completed.
Sponsor:
Collaborator:
HelseNord Norway, University of Tromso, Norway
Information provided by:
Northern State Medical University
ClinicalTrials.gov Identifier:
NCT00624494
First received: February 13, 2008
Last updated: January 4, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Hemodynamic Monitoring,
Goal Directed Therapy
Device: Conventional monitoring
Device: Advanced monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single Transpulmonary Thermodilution and Continuous Monitoring of Central Venous Oxygen Saturation During Off-pump Coronary Surgery

Resource links provided by NLM:


Further study details as provided by Northern State Medical University:

Primary Outcome Measures:
  • length of hospital stay [ Time Frame: one month ] [ Designated as safety issue: Yes ]
    Length of the hospital stays, Days


Enrollment: 40
Study Start Date: May 2005
Study Completion Date: September 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional monitoring
hemodynamic monitoring - conventional monitoring
Device: Conventional monitoring
In the CM group, therapy was guided by central venous pressure, mean arterial pressure (MAP) and heart rate (HR)
Other Name: Non actual
Active Comparator: Advanced monitoring
hemodynamic monitoring - advanced monitoring
Device: Advanced 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.
Other Name: PiCCO-CeVOX

Detailed Description:

At the present time, there is an increasing tendency to perform off-pump coronary artery bypass grafting (OPCAB). However, OPCAB poses a variety of challenges from the point of view of the anesthesiologist and the intensivist. 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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Age < 18 years
  • Severe valve dysfunction or peripheral vascular disease
  • Simultaneous interventions (carotid endarterectomy, aneurysm repair, etc.)
  • Transfer to CPB during surgery
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00624494

Locations
Russian Federation
Dep. of Anesthesiology, Northern SMU
Arkhangelsk, Russian Federation, 163000
Sponsors and Collaborators
Northern State Medical University
HelseNord Norway, University of Tromso, Norway
Investigators
Study Director: Mikhail Y Kirov Northern SMU
  More Information

Publications:
Responsible Party: Mikhail Kirov, Professor, Northern State Medical University
ClinicalTrials.gov Identifier: NCT00624494     History of Changes
Other Study ID Numbers: 4347.07.2006, Grant 4347.07.2006
Study First Received: February 13, 2008
Last Updated: January 4, 2011
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by Northern State Medical University:
venous oxygen saturation
transpulmonary thermodilution

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014