Comparison of Goal-directed Algorithms of Hemodynamic Therapy After Combined Valve Repair
1 other identifier
interventional
43
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 4, 2011
CompletedFirst Posted
Study publicly available on registry
January 13, 2011
CompletedJanuary 13, 2011
January 1, 2011
2.6 years
January 4, 2011
January 12, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality
Mortality rate at Day 28
Day 28
Secondary Outcomes (3)
Fit for discharge
non actual
Vasoactive support
7 days
Duration of respiratory support
Day 7
Study Arms (2)
Pulmonary artery catheter (PAC)
ACTIVE COMPARATORPAC was used to guide hemodynamic therapy after combined valve repair
COMPLEX
ACTIVE COMPARATORAn combination of transpulmonary thermodilution and continuous monitoring of central venous saturation was used to guide hemodynamic therapy after combined valve repair surgery.
Interventions
the data s=derived from PAC included pulmonary artery occlusion pressure etc
Described in details above
Eligibility Criteria
You may qualify if:
- Two valve repair / replacements
- Age above 18
- Informed consent
You may not qualify if:
- pulmonary hypertension
- insulin-dependent diabetes mellitus
- severe atherosclerosis of femoral arteries
- severe respiratory failure
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northern State Medical Universitylead
- University of Tromsocollaborator
Study Sites (1)
City hospital # 1 / Northern State Medical University,
Arkhangelsk, 163000, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mikhail Y. Kirov, MD, PhD
Northern State Medical University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 4, 2011
First Posted
January 13, 2011
Study Start
January 1, 2008
Primary Completion
August 1, 2010
Study Completion
September 1, 2010
Last Updated
January 13, 2011
Record last verified: 2011-01