Comparison of Goal-directed Algorithms of Hemodynamic Therapy After Combined Valve Repair
NCT ID: NCT01276444
Last Updated: 2011-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
43 participants
INTERVENTIONAL
2008-01-31
2010-09-30
Brief Summary
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Several approaches were introduced into the clinical practice to alleviate systemic inflammatory response induced by cardiopulmonary bypass and organ-specific injury including meticulous haemodynamic monitoring, pharmacological heart preconditioning, systemic use of anti-inflammatory agents, prevention of coagulopathy, and induced topical and systemic hypothermia. An in-depth monitoring of haemodynamics, oxygen transport, and vascular permeability is of a great clinical value to control the efficacy of these approaches.
Therefore, the aim of this study was to compare two algorithms of goal-directed therapy aimed to achieve a postoperative haemodynamic optimization in combined valve repair surgery.
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Detailed Description
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Day before surgery patients were asked for informed consent and randomized in two groups. In the first group postoperative haemodynamic optimization was targeted on parameters provided by pulmonary artery catheter (the PAC-group, n = 20): pulmonary arterial occlusion pressure, cardiac index (LifeScope monitor, Nihon Kohden, Japan) and hemoglobin blood level. In the second group haemodynamics was managed using parameters given by transpulmonary thermodilution (the COMPLEX-group), that included cardiac index, global end-diastolic volume index, extravascular lung water index, continuous central venous oxygen saturation, and oxygen delivery index as measured with PiCCO2 monitor (Pulsion Medical Systems, Munich, Germany. In addition, mean arterial pressure, heart rate, and hemoglobin concentration were included into both PAC- and PiCCO2-driven protocols.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Pulmonary artery catheter (PAC)
PAC was used to guide hemodynamic therapy after combined valve repair
Swan-Ganz catheter
the data s=derived from PAC included pulmonary artery occlusion pressure etc
COMPLEX
An combination of transpulmonary thermodilution and continuous monitoring of central venous saturation was used to guide hemodynamic therapy after combined valve repair surgery.
transpulmonary thermodilution + central venous saturation
Described in details above
Interventions
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Swan-Ganz catheter
the data s=derived from PAC included pulmonary artery occlusion pressure etc
transpulmonary thermodilution + central venous saturation
Described in details above
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age above 18
* Informed consent
Exclusion Criteria
* insulin-dependent diabetes mellitus
* severe atherosclerosis of femoral arteries
* severe respiratory failure
* pregnancy
18 Years
ALL
No
Sponsors
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University of Tromso
OTHER
Northern State Medical University
OTHER
Responsible Party
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Northern State Medical University
Principal Investigators
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Mikhail Y. Kirov, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Northern State Medical University
Locations
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City hospital # 1 / Northern State Medical University,
Arkhangelsk, , Russia
Countries
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Other Identifiers
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SCVO2-2008
Identifier Type: -
Identifier Source: org_study_id
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