Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01276444
Enrollment
43
Registered
2011-01-13
Start date
2008-01-31
Completion date
2010-09-30
Last updated
2011-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Valvular Heart Disease

Keywords

valve repair, postoperative period, goal-directed therapy, pulmonary artery catheter, transpulmonary thermodilution, central venous oxygen saturation

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.

Interventions

the data s=derived from PAC included pulmonary artery occlusion pressure etc

DEVICEtranspulmonary thermodilution + central venous saturation

Described in details above

Sponsors

University of Tromso
CollaboratorOTHER
Northern State Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
MortalityDay 28Mortality rate at Day 28

Secondary

MeasureTime frameDescription
Fit for dischargenon actualFormal 'fit for discharge from ICU' criteria
Vasoactive support7 daysDuration of vasopressor and or inotrope support
Duration of respiratory supportDay 7The total duration of the respiratory support

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026