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A Total Balanced Volume Replacement Regimen in Elderly Cardiac Surgery Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00576849
First Posted: December 19, 2007
Last Update Posted: May 27, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Klinikum Ludwigshafen
  Purpose
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.

Condition Intervention Phase
Elderly Cardiac Surgery Drug: Balanced HES 130/0.42 Drug: 6% HES 130/0.4 prepared in saline solution Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Phase 4 Study of a Total Balanced Volume Replacement Regimen in Elderly Cardiac Surgery Patients

Resource links provided by NLM:


Further study details as provided by Klinikum Ludwigshafen:

Primary Outcome Measures:
  • The primary endpoint of the study is postoperative renal function [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • Other organ function (myocardial function, endothelial function, degree of inflammation) [ Time Frame: Postoperative period ]

Estimated Enrollment: 50
Study Start Date: December 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Total balanced volume replacement regimen consisting of a balanced HES 130/0.42 plus a balanced crystalloid
Drug: 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
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
Active Comparator: B
Conventional volume replacement strategy consisting of 6% HES 130/0.4 prepared in saline solution plus Ringer`s lactate
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   80 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged >80 years

Exclusion Criteria:

  • Chronic kidney dysfunction requiring dialysis
  • Myocardial infarction within the previous 3 weeks
  • Liver insufficiency
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00576849


Locations
Germany
Klinikum Ludwigshafen
Ludwigshafen, RLP, Germany, 67063
Sponsors and Collaborators
Klinikum Ludwigshafen
Investigators
Principal Investigator: Joachim Boldt, M.D. Klinikum Ludwigshafen
  More Information

Responsible Party: Prof. Dr. Joachim Boldt, Department of Anesthesiology and Intensive Care Medicine
ClinicalTrials.gov Identifier: NCT00576849     History of Changes
Other Study ID Numbers: HES2007
First Submitted: December 18, 2007
First Posted: December 19, 2007
Last Update Posted: May 27, 2010
Last Verified: January 2009