A Total Balanced Volume Replacement Regimen in Elderly Cardiac Surgery Patients

This study has been completed.
Sponsor:
Information provided by:
Klinikum Ludwigshafen
ClinicalTrials.gov Identifier:
NCT00576849
First received: December 18, 2007
Last updated: May 25, 2010
Last verified: January 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   80 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 18, 2007
Last Updated: May 25, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on April 22, 2014