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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00624494
First Posted: February 27, 2008
Last Update Posted: January 6, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Tromso
Information provided by:
Northern State Medical University
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00624494


Locations
Russian Federation
Dep. of Anesthesiology, Northern SMU
Arkhangelsk, Russian Federation, 163000
Sponsors and Collaborators
Northern State Medical University
University of Tromso
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 ( Other Identifier: HelseNord )
First Submitted: February 13, 2008
First Posted: February 27, 2008
Last Update Posted: January 6, 2011
Last Verified: January 2011

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

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