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

Valvular Heart Disease Clinical Trial

Official title:

Comparison of Goal-directed Algorithms of Hemodynamic Therapy After Combined Valve Repair: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01276444
• Other study ID #: SCVO2-2008
• Status: Completed
• Phase: N/A
• First received: January 4, 2011
• Last updated: January 12, 2011
• Start date: January 2008
• Est. completion date: September 2010

Study information

• Verified date: January 2011
• Source: Northern State Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Heart Valve Diseases
• Valvular Heart Disease

Intervention

Device:
• Swan-Ganz catheter
the data s=derived from PAC included pulmonary artery occlusion pressure etc
• transpulmonary thermodilution + central venous saturation
Described in details above

Locations

Country	Name	City	State
Russian Federation	City hospital # 1 / Northern State Medical University,	Arkhangelsk

Sponsors (2)

Lead Sponsor	Collaborator
Northern State Medical University	University of Tromso

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Mortality rate at Day 28	Day 28	No
Secondary	Fit for discharge	Formal 'fit for discharge from ICU' criteria	non actual	No
Secondary	Vasoactive support	Duration of vasopressor and or inotrope support	7 days	No
Secondary	Duration of respiratory support	The total duration of the respiratory support	Day 7	No