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

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

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.

Study Overview

• Status: Completed
• Conditions: Valvular Heart Disease
• Intervention / Treatment: Device: Swan-Ganz catheter; Device: transpulmonary thermodilution + central venous saturation

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Arkhangelsk, Russian Federation, 163000
    • City hospital # 1 / Northern State Medical University,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Non actual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality rate at Day 28	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fit for discharge	Formal 'fit for discharge from ICU' criteria	non actual
Vasoactive support	Duration of vasopressor and or inotrope support	7 days
Duration of respiratory support	The total duration of the respiratory support	Day 7

Collaborators and Investigators

• Sponsor: Northern State Medical University
• Collaborators: University of Tromso
• Investigators: Principal Investigator: Mikhail Y. Kirov, MD, PhD, Northern State Medical University

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: January 4, 2011
• First Submitted That Met QC Criteria: January 12, 2011
• First Posted (Estimate): January 13, 2011

Study Record Updates

• Last Update Posted (Estimate): January 13, 2011
• Last Update Submitted That Met QC Criteria: January 12, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: postoperative period; pulmonary artery catheter; transpulmonary thermodilution; central venous oxygen saturation; goal-directed therapy; valve repair
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases
• Other Study ID Numbers: SCVO2-2008