A Total Balanced Volume Replacement Regimen in Elderly Cardiac Surgery Patients - Full Text View

Sponsored by:	Klinikum Ludwigshafen
Information provided by:	Klinikum Ludwigshafen
ClinicalTrials.gov Identifier:	NCT00576849

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 IV

MedlinePlus related topics: Heart Surgery Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 4 Study of a Total Balanced Volume Replacement Regimen in Elderly Cardiac Surgery Patients

Further study details as provided by Klinikum Ludwigshafen:

Primary Outcome Measures:

The primary endpoint of the study is postoperative renal function [ Time Frame: Postoperative period ] [ 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
Estimated Study Completion Date:	March 2008

Arms	Assigned Interventions
A: Experimental 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
B: Active Comparator 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

Arms

Assigned Interventions

A: Experimental

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

B: Active Comparator

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

Contacts

Contact: Joachim Boldt, M.D.	0621-503 ext 3000	boldtj@gmx.net
Contact: Stefan Suttner, M.D.	0621-503 ext 3000	suttner@gmx.de

Locations

Germany, RLP
Klinikum Ludwigshafen	Recruiting
Ludwigshafen, RLP, Germany, 67063
Contact: Joachim Boldt, M.D. 0621-503 ext 3000 boldtj@gmx.net
Principal Investigator: Joachim Boldt, M.D.

Sponsors and Collaborators

Klinikum Ludwigshafen

Investigators

Principal Investigator:

Joachim Boldt, M.D.

Klinikum Ludwigshafen

More Information

No publications provided

Responsible Party:	Department of Anesthesiology and Intensive Care Medicine ( Prof. Dr. Joachim Boldt )
Study ID Numbers:	HES2007
Study First Received:	December 18, 2007
Last Updated:	December 18, 2007
ClinicalTrials.gov Identifier:	NCT00576849 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on May 07, 2009