Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01276444
Other study ID # SCVO2-2008
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Completed NCT02241109 - Predicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity N/A
Completed NCT03799133 - Safety and Efficacy of the Gastric Reactance (XL) in Patients Post-operated of Elective Cardiac Surgery N/A
Completed NCT01676727 - ADVANCE Direct Aortic Study
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Completed NCT00721136 - Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation N/A
Recruiting NCT05044338 - Study on Standard Evaluation System and Optimal Treatment Path of Senile Valvular Heart Disease
Recruiting NCT05014750 - Frailty of Elderly With Valvular Heart Disease and the Short Term Adverse Events
Recruiting NCT05015829 - Diagnostic Impact of Low-dose Dobutamine Echocardiography in Low-flow Low-gradient Aortic Stenosis
Recruiting NCT05078619 - Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation N/A
Recruiting NCT06307262 - European Registry of Transcatheter Repair for Tricuspid Regurgitation
Completed NCT01624870 - CoreValve Advance-II Study: Prospective International Post-market Study
Completed NCT05708690 - Topical Effect of Tranexamic Acid in Postoperative Bleeding and Blood Products Transfusion After Cardiac Surgery Phase 4
Recruiting NCT03797820 - Multicenter Registry Study of Aortic Valve Stenosis in Zhejiang Elderly(Mrs AVS)
Recruiting NCT06077721 - Milrinone on Right Ventricular Strain in Cardiac Surgery
Not yet recruiting NCT04632914 - Effect of Trunk Stabilizing Exercises on Patients With Median Sternotomy After Heart Valve Surgery N/A
Completed NCT01477151 - Randomized Isoflurane and Sevoflurane Comparison in Cardiac Surgery Phase 4
Terminated NCT03590730 - Benefits of ICD for the Primary Prevention in Patients With Valvular Cardiomyopathy
Recruiting NCT06204783 - Real-time Pressure Volume Loop Monitoring as a Guide for Enhanced Understanding of Changes in Elemental Cardiovascular Physiology During Therapeutic Strategies Aiming for Hemodynamic Optimization. Cohort II: Structural Heart Interventions (PLUTO-II)
Enrolling by invitation NCT05775354 - Reviving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project N/A