Clinical trial NCT01276444: 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
Overall status: COMPLETED
Phase: NA
Conditions: Valvular Heart Disease
Keywords: valve repair
postoperative period
goal-directed therapy
pulmonary artery catheter
transpulmonary thermodilution
central venous oxygen saturation
Lead sponsor: Northern State Medical University
Sponsor class: OTHER
Collaborators: name: University of Tromso
First posted: 2011-01-13
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Mortality
timeFrame: Day 28
Secondary outcomes:
measure: Fit for discharge
timeFrame: non actual
measure: Vasoactive support
timeFrame: 7 days
measure: Duration of respiratory support
timeFrame: Day 7
Other outcomes:
Locations:
city: Arkhangelsk
country: Russian Federation
facility: City hospital # 1 / Northern State Medical University,
Study officials:
affiliation: Northern State Medical University
name: Mikhail Y. Kirov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: