Optimal Flow Rate During Cardiopulmonary Bypass

NCT ID: NCT01105078

Last Updated: 2014-08-06

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Brief Summary

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Regardless of the development of cardiac surgery techniques and technologies, the question of an optimal extracorporeal circulation is still unanswered. There are globally accepted standards of perfusion, however, keep many of these procedures was not evidence-based review.

Generally accepted are flow rates during cardiopulmonary bypasses of 2.5 L/min/m2. This target was derived from the physiological conditions, but they are not the result of an adapted adjustment to the fundamentally non-physiological processes during extracorporeal circulation. Among other things, an increased metabolic demand during re-perfusion is not taken into account.

An increasing and optimizing of the standard flow rate of 0.5 L/min/m2 should be the aim of this investigation. Under optimal perfusion, the investigators are maintaining the microcirculation and organ protection in receipt of endothelial function and oxygen transport.

Detailed Description

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Conditions

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Tissue Perfusion

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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Flow rate

Comparison between a flow rate of 2.5/l/min/m2 versus 3.0/l/min/m2

Group Type OTHER

Flow rate

Intervention Type PROCEDURE

Different flow rate during cardiopulmonary bypass

Interventions

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Flow rate

Different flow rate during cardiopulmonary bypass

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Extracorporeal circulation
* Age \> 18
* Written consent

Exclusion Criteria

* Emergency cases
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Arndt-H. Kiessling

Head cardiovascular research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Johann Wolfgang Goethe University Hospital

Frankfurt am Main, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Arndt H Kiessling, MD

Role: CONTACT

+49696301 ext. 6705

Facility Contacts

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Arndt H Kiessling, MD

Role: primary

+49696301 ext. 6705

Related Links

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http://www.kgu.de

Klinikum der Johann Wolfgang Goethe Universität Frankfurt aM Germany

Other Identifiers

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CI001AZ-AHK

Identifier Type: -

Identifier Source: org_study_id

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