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

Primary Purpose

Valvular Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Swan-Ganz catheter
transpulmonary thermodilution + central venous saturation
Sponsored by
Northern State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Valvular Heart Disease focused on measuring valve repair, postoperative period, goal-directed therapy, pulmonary artery catheter, transpulmonary thermodilution, central venous oxygen saturation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City hospital # 1 / Northern State Medical University,

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pulmonary artery catheter (PAC)

COMPLEX

Arm Description

PAC was used to guide hemodynamic therapy after combined valve repair

An combination of transpulmonary thermodilution and continuous monitoring of central venous saturation was used to guide hemodynamic therapy after combined valve repair surgery.

Outcomes

Primary Outcome Measures

Mortality
Mortality rate at Day 28

Secondary Outcome Measures

Fit for discharge
Formal 'fit for discharge from ICU' criteria
Vasoactive support
Duration of vasopressor and or inotrope support
Duration of respiratory support
The total duration of the respiratory support

Full Information

First Posted
January 4, 2011
Last Updated
January 12, 2011
Sponsor
Northern State Medical University
Collaborators
University of Tromso
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1. Study Identification

Unique Protocol Identification Number
NCT01276444
Brief Title
Comparison of Goal-directed Algorithms of Hemodynamic Therapy After Combined Valve Repair
Official Title
Comparison of Goal-directed Algorithms of Hemodynamic Therapy After Combined Valve Repair: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Northern State Medical University
Collaborators
University of Tromso

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Valvular Heart Disease
Keywords
valve repair, postoperative period, goal-directed therapy, pulmonary artery catheter, transpulmonary thermodilution, central venous oxygen saturation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulmonary artery catheter (PAC)
Arm Type
Active Comparator
Arm Description
PAC was used to guide hemodynamic therapy after combined valve repair
Arm Title
COMPLEX
Arm Type
Active Comparator
Arm Description
An combination of transpulmonary thermodilution and continuous monitoring of central venous saturation was used to guide hemodynamic therapy after combined valve repair surgery.
Intervention Type
Device
Intervention Name(s)
Swan-Ganz catheter
Other Intervention Name(s)
Not actual
Intervention Description
the data s=derived from PAC included pulmonary artery occlusion pressure etc
Intervention Type
Device
Intervention Name(s)
transpulmonary thermodilution + central venous saturation
Other Intervention Name(s)
Non actual
Intervention Description
Described in details above
Primary Outcome Measure Information:
Title
Mortality
Description
Mortality rate at Day 28
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Fit for discharge
Description
Formal 'fit for discharge from ICU' criteria
Time Frame
non actual
Title
Vasoactive support
Description
Duration of vasopressor and or inotrope support
Time Frame
7 days
Title
Duration of respiratory support
Description
The total duration of the respiratory support
Time Frame
Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikhail Y. Kirov, MD, PhD
Organizational Affiliation
Northern State Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
City hospital # 1 / Northern State Medical University,
City
Arkhangelsk
ZIP/Postal Code
163000
Country
Russian Federation

12. IPD Sharing Statement

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

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