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Effect of Perioperative Hemodynamic Optimization on the Immune Function Parameters of Peripheral Blood Monocytes After Cardiac Surgery

NCT ID: NCT01184430

Last Updated: 2013-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-12-31

Brief Summary

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Cardiac surgery patients have a high risk to suffer from postoperative infections. Some studies have shown, that humoral and cellular factors are associated with perioperative immunodysfunction and can increase the risk of postoperative infections. Monocytes in the blood and, especially alveolar macrophages are important for an adequate host defence. In studies the investigators have shown that hemodynamic parameters have a significant influence on the probability to develop postoperative infections. The aim of the study is to investigate, whether cardiac surgery patients have an altered immune function after surgery that is predictive for the latter development of subsequent infections and whether they benefit from a goal-directed volume and hemodynamic therapy.

Detailed Description

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Conditions

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Postoperative Wound Infection Postoperative Outcome

Keywords

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advanced hemodynamic monitoring goal-directed therapy cardiac surgery hemodynamic monitoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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advanced hemodynamic monitoring

advanced hemodynamic monitoring with pulse contour analysis ( LiDCO rapid) and goal-directed therapy

Group Type ACTIVE_COMPARATOR

Pulse contour cardiac output device

Intervention Type DEVICE

Goal directed volume therapy using stroke volume variation and cardiac output to guide volume therapy and inotropic support.

standard monitoring

hemodynamic monitoring based on the standard operating procedures of our clinic

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pulse contour cardiac output device

Goal directed volume therapy using stroke volume variation and cardiac output to guide volume therapy and inotropic support.

Intervention Type DEVICE

Other Intervention Names

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Non calibrated pulse contour cardiac output monitor

Eligibility Criteria

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Inclusion Criteria

* elective cardiac surgery patient undergoing cardiopulmonary bypass
* signed informed consent

Exclusion Criteria

* pregnant or breast feeding women
* Age \<18 years
* pulmonary disease with an oxygenation index \<300mmHg
* liver disease (\>Child B)
* HIV-Infection
* Therapy with corticosteroids
* Condition after transplantation
* preexisting infection before operation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Michael Sander

Vice Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Sander, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Anesthesiology Charité Universitaetsmedizin Berlin

Claudia Spies, MD

Role: STUDY_CHAIR

Dept. of Anesthesiology Charité Universitaetsmedizin Berlin

Locations

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Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum

Berlin, , Germany

Site Status

Countries

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Germany

Central Contacts

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Michael Sander, MD

Role: CONTACT

Phone: +49 30 450 531

Email: [email protected]

Katharina Berger, MD

Role: CONTACT

Phone: +49 30 450 531

Email: [email protected]

Facility Contacts

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Michael Sander, MD

Role: primary

Other Identifiers

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Algebra

Identifier Type: -

Identifier Source: org_study_id