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Arterial Pressure Based Cardiac Output for Goal-Directed Therapy in Abdominal Surgery

NCT ID: NCT00549419

Last Updated: 2009-12-23

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-04-30

Brief Summary

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The purpose of this study is to determine whether the early identification and more precise intervention of goal-directed intraoperative plasma volume expansion and catecholamine therapy using arterial pressure based cardiac output (APCO) measurement in addition to normal vital signs will improve postoperative organ function, in particular renal function, in patients undergoing major abdominal surgery.

Detailed Description

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Conditions

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Major Abdominal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

In the Treatment group, the traditional vital signs and APCO are made continuously available for fluid and catecholamine optimization and clinical decision making.

Group Type EXPERIMENTAL

Goal-directed hemodynamic therapy

Intervention Type DRUG

Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine

2

Group Type ACTIVE_COMPARATOR

Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine

Intervention Type DRUG

The Control group will be assessed using the standard care of traditional vital signs

Standard of care

Intervention Type DRUG

Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine

Interventions

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Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine

The Control group will be assessed using the standard care of traditional vital signs

Intervention Type DRUG

Goal-directed hemodynamic therapy

Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine

Intervention Type DRUG

Standard of care

Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient is scheduled for elective major abdominal surgery and has two or more risk factors according to the Lee classification scheme.
* Patient can sign informed consent before surgery.
* Patient is able to comply with the study procedure.
* Patient must require an indwelling radial or a femoral artery catheter.
* Patient must be 20 years old or older.
* Patient must be 40kg or heavier.
* Patients height and weight can be accurately obtained prior to study start.

Exclusion Criteria

* Emergency surgery.
* Patients with aortic or mitral valve regurgitation.
* Renal insufficiency requiring hemodialysis.
* Liver dysfunction (alanine/aspartate aminotransferase \>40 U/L).
* Patient with contraindications for the placement of radial, femoral or other arterial cannulae.
* Patient being treated with an intraaortic balloon pump.
* Female patients with a known pregnancy.
* Patient is currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the study endpoints.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Klinikum Ludwigshafen

OTHER

Sponsor Role lead

Responsible Party

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Klinikum Ludwigshafen

Principal Investigators

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Stefan W. Suttner, M.D. Ph.D.

Role: STUDY_DIRECTOR

Klinikum Ludwigshafen

Locations

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Klinikum Ludwigshafen

Ludwigshafen, RLP, Germany

Site Status

Countries

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Germany

References

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Mayer J, Boldt J, Mengistu AM, Rohm KD, Suttner S. Goal-directed intraoperative therapy based on autocalibrated arterial pressure waveform analysis reduces hospital stay in high-risk surgical patients: a randomized, controlled trial. Crit Care. 2010;14(1):R18. doi: 10.1186/cc8875. Epub 2010 Feb 15.

Reference Type DERIVED
PMID: 20156348 (View on PubMed)

Other Identifiers

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2007-06

Identifier Type: -

Identifier Source: org_study_id