A Total Balanced Volume Replacement Regimen in Elderly Cardiac Surgery Patients

NCT ID: NCT00576849

Last Updated: 2010-05-27

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-05-31

Brief Summary

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A total balanced fluid replacement strategy is a promising concept for correcting hypovolemia. The effects of a balanced fluid management including a new balanced hydroxyethylstarch (HES) in elderly cardiac surgery patients will be studied.

Detailed Description

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Conditions

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Elderly Cardiac 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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A

Total balanced volume replacement regimen consisting of a balanced HES 130/0.42 plus a balanced crystalloid

Group Type EXPERIMENTAL

Balanced HES 130/0.42

Intervention Type DRUG

Volume is administered perioperatively and during the first 48 hrs after surgery when mean arterial pressure (MAP) was \<60mmHg and pulmonary capillary wedge pressure (PCWP) or central venous pressure (CVP) is \<10 mmHg

Balanced HES 130/0.42

Intervention Type DRUG

Volume will be administered perioperatively and during the first 48 hrs after surgery when mean arterial pressure (MAP) is \<60mmHg and pulmonary capillary wedge pressure (PCWP) or central venous pressure (CVP) is \<10 mmHg

B

Conventional volume replacement strategy consisting of 6% HES 130/0.4 prepared in saline solution plus Ringer's lactate

Group Type ACTIVE_COMPARATOR

6% HES 130/0.4 prepared in saline solution

Intervention Type DRUG

Volume will be administered perioperatively and during the first 48 hrs after surgery when mean arterial pressure (MAP) is \<60mmHg and pulmonary capillary wedge pressure (PCWP) or central venous pressure (CVP) is \<10 mmHg

Interventions

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Balanced HES 130/0.42

Volume is administered perioperatively and during the first 48 hrs after surgery when mean arterial pressure (MAP) was \<60mmHg and pulmonary capillary wedge pressure (PCWP) or central venous pressure (CVP) is \<10 mmHg

Intervention Type DRUG

Balanced HES 130/0.42

Volume will be administered perioperatively and during the first 48 hrs after surgery when mean arterial pressure (MAP) is \<60mmHg and pulmonary capillary wedge pressure (PCWP) or central venous pressure (CVP) is \<10 mmHg

Intervention Type DRUG

6% HES 130/0.4 prepared in saline solution

Volume will be administered perioperatively and during the first 48 hrs after surgery when mean arterial pressure (MAP) is \<60mmHg and pulmonary capillary wedge pressure (PCWP) or central venous pressure (CVP) is \<10 mmHg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients aged \>80 years

Exclusion Criteria

* Chronic kidney dysfunction requiring dialysis
* Myocardial infarction within the previous 3 weeks
* Liver insufficiency
Minimum Eligible Age

80 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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Department of Anesthesiology and Intensive Care Medicine

Principal Investigators

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Joachim Boldt, M.D.

Role: PRINCIPAL_INVESTIGATOR

Klinikum Ludwigshafen

Locations

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Klinikum Ludwigshafen

Ludwigshafen, RLP, Germany

Site Status

Countries

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Germany

Other Identifiers

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HES2007

Identifier Type: -

Identifier Source: org_study_id

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