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

Northern State Medical University

Status: Completed

Conditions: Valvular Heart Disease

Treatments: Device: transpulmonary thermodilution + central venous saturation; Device: Swan-Ganz catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT01276444

SCVO2-2008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Pulmonary artery catheter (PAC)

Active Comparator group

Description:

PAC was used to guide hemodynamic therapy after combined valve repair

Treatment:

Device: Swan-Ganz catheter

COMPLEX

Active Comparator group

Description:

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

Treatment:

Device: transpulmonary thermodilution + central venous saturation