Comparison of Goal-directed Algorithms of Hemodynamic The... | NCT01276444

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

NCT01276444

Sponsor

Northern State Medical University

Status

Completed

Last Update Posted

Jan 13, 2011Estimated

Enrollment

43Actual

Phase

Not Applicable

Conditions

Valvular Heart Disease

Interventions

Swan-Ganz catheter
transpulmonary thermodilution + central venous saturation

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Aug 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Jan 4, 2011

First Submission Date that Met QC Criteria

Jan 12, 2011

First Posted Date

Jan 13, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2011

Last Update Posted Date

Jan 13, 2011Estimated

Name	Class
University of Tromso	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

43Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pulmonary artery catheter (PAC)	Active Comparator	PAC was used to guide hemodynamic therapy after combined valve repair	Device: Swan-Ganz catheter
COMPLEX	Active Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Swan-Ganz catheter	Device	the data s=derived from PAC included pulmonary artery occlusion pressure etc	Pulmonary artery catheter (PAC)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mikhail Y. Kirov, MD, PhD	Northern State Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
City hospital # 1 / Northern State Medical University,		Arkhangelsk		163000	Russia

Condition Browse Module

MeSH Terms

ID	Term
D006349	Heart Valve Diseases

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

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Browse Branches

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