A Total Balanced Volume Replacement Regimen in Elderly Cardiac Surgery Patients
NCT ID: NCT00576849
Last Updated: 2010-05-27
Study Results
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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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2007-12-31
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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A
Total balanced volume replacement regimen consisting of a balanced HES 130/0.42 plus a balanced crystalloid
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
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
B
Conventional volume replacement strategy consisting of 6% HES 130/0.4 prepared in saline solution plus Ringer's lactate
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
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
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
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Myocardial infarction within the previous 3 weeks
* Liver insufficiency
80 Years
ALL
No
Sponsors
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Klinikum Ludwigshafen
OTHER
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
Countries
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Other Identifiers
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HES2007
Identifier Type: -
Identifier Source: org_study_id
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