Single Transpulmonary Thermodilution and Monitoring of Central Venous Oxygen Saturation (OPCAB)


Tracking Information

Start Date  ICMJEMay 2005
Primary Completion DateFebruary 2008   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: February 26, 2008)
length of hospital stay [ Time Frame: one month ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00624494 on ClinicalTrials.gov Archive Site

Descriptive Information

Brief Title  ICMJESingle Transpulmonary Thermodilution and Monitoring of Central Venous Oxygen Saturation
Official Title  ICMJESingle Transpulmonary Thermodilution Combined With Continuous Monitoring of Central Venous Oxygen Saturation During Off-Pump Coronary Artery Bypass Grafting: a Randomized Controlled Trial
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.

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.

Study Phase 
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Condition  ICMJECoronary Artery Disease
Intervention  ICMJE
  • Device: PiCCO and CeVOX monitors (Pulsion Medical Systems)
    All patients included were randomized into two groups of hemodynamic monitoring: conventional monitoring (CM) group (n = 20) and advanced monitoring (AM) group (n = 20). The CM group was managed according to heart rate (HR), central venous pressure, and mean arterial pressure (MAP).
    Other Name: venous oxygen saturation; transpulmonary thermodilution
  • Device: PiCCO and CeVOX monitors (Pulsion Medical Systems)
    All patients included were randomized into two groups of hemodynamic monitoring: conventional monitoring (CM) group (n = 20) and advanced monitoring (AM) group (n = 20). In the AM group, therapy was guided by intrathoracic blood volume index and cardiac index determined with STD, MAP, HR, and continuous measurement of ScvO2.
Study Arms / Comparison Groups
  • 2
    hemodynamic monitoring - conventional monitoring
    Intervention: Device: PiCCO and CeVOX monitors (Pulsion Medical Systems)
  • 1
    hemodynamic monitoring - advanced monitoring
    Intervention: Device: PiCCO and CeVOX monitors (Pulsion Medical Systems)

Recruitment Information

Estimated Enrollment  ICMJE40
Estimated Completion DateMarch 2008
Primary Completion DateFebruary 2008   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
GenderBoth
Ages18 Years to 90 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Mikhail Y Kirov, Prof.+79217215691mikhail_kirov@hotmail.com
Location Countries  ICMJERussian Federation

Administrative Information

NCT ID  ICMJENCT00624494
Responsible PartyMikhail Kirov, Professor, Northern State Medical University
Study ID Numbers  ICMJE4347.07.2006, Grant 4347.07.2006
Study Sponsor  ICMJENorthern State Medical University
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Mikhail Y KirovNorthern SMU
Information Provided ByNorthern State Medical University