Comparison of Goal-directed Algorithms of Hemodynamic Therapy After Combined Valve Repair

This study has been completed.
Sponsor:
Collaborator:
University of Tromso
Information provided by:
Northern State Medical University
ClinicalTrials.gov Identifier:
NCT01276444
First received: January 4, 2011
Last updated: January 12, 2011
Last verified: January 2011
  Purpose

Valvular repair and repair surgery is rapidly progressing yet rather challenging aspect of current cardiosurgical practice.

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.


Condition Intervention
Valvular Heart Disease
Device: Swan-Ganz catheter
Device: transpulmonary thermodilution + central venous saturation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Comparison of Goal-directed Algorithms of Hemodynamic Therapy After Combined Valve Repair: a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Northern State Medical University:

Primary Outcome Measures:
  • Mortality [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    Mortality rate at Day 28


Secondary Outcome Measures:
  • Fit for discharge [ Time Frame: non actual ] [ Designated as safety issue: No ]
    Formal 'fit for discharge from ICU' criteria

  • Vasoactive support [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Duration of vasopressor and or inotrope support

  • Duration of respiratory support [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    The total duration of the respiratory support


Enrollment: 43
Study Start Date: January 2008
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pulmonary artery catheter (PAC)
PAC was used to guide hemodynamic therapy after combined valve repair
Device: Swan-Ganz catheter
the data s=derived from PAC included pulmonary artery occlusion pressure etc
Other Name: Not actual
Active Comparator: COMPLEX
An combination of transpulmonary thermodilution and continuous monitoring of central venous saturation was used to guide hemodynamic therapy after combined valve repair surgery.
Device: transpulmonary thermodilution + central venous saturation
Described in details above
Other Name: Non actual

Detailed Description:

Forty-three adult patients scheduled for elective two valve replacement/repair were enrolled into randomised single-centre study. All interventions were performed in cardiosurgical department of City hospital #1 (Arkhangelsk, Russian Federation) by the same surgical team. Three patients were excluded from the analysis; two — due to protocol violation and one — due to inadequate surgical correction diagnosed by intraoperative transoesophageal echocardiography.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Two valve repair / replacements
  • Age above 18
  • Informed consent

Exclusion Criteria:

  • pulmonary hypertension
  • insulin-dependent diabetes mellitus
  • severe atherosclerosis of femoral arteries
  • severe respiratory failure
  • pregnancy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01276444

Locations
Russian Federation
City hospital # 1 / Northern State Medical University,
Arkhangelsk, Russian Federation, 163000
Sponsors and Collaborators
Northern State Medical University
University of Tromso
Investigators
Principal Investigator: Mikhail Y. Kirov, MD, PhD Northern State Medical University
  More Information

No publications provided

Responsible Party: Northern State Medical University
ClinicalTrials.gov Identifier: NCT01276444     History of Changes
Other Study ID Numbers: SCVO2-2008
Study First Received: January 4, 2011
Last Updated: January 12, 2011
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by Northern State Medical University:
valve repair
postoperative period
goal-directed therapy
pulmonary artery catheter
transpulmonary thermodilution
central venous oxygen saturation

Additional relevant MeSH terms:
Heart Diseases
Heart Valve Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014