A Total Balanced Volume Replacement Regimen in Elderly Cardiac Surgery Patients

Cardiac Surgery Clinical Trial

Official title:

Phase 4 Study of a Total Balanced Volume Replacement Regimen in Elderly Cardiac Surgery Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00576849
• Other study ID #: HES2007
• Status: Completed
• Phase: Phase 4
• First received: December 18, 2007
• Last updated: May 25, 2010
• Start date: December 2007
• Est. completion date: May 2010

Study information

• Verified date: January 2009
• Source: Klinikum Ludwigshafen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 80 Years and older

Eligibility

Inclusion Criteria:

• Patients aged >80 years

Exclusion Criteria:

• Chronic kidney dysfunction requiring dialysis

• Myocardial infarction within the previous 3 weeks

• Liver insufficiency

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Surgery
• Elderly

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	Klinikum Ludwigshafen	Ludwigshafen	RLP

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum Ludwigshafen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint of the study is postoperative renal function		28 days	Yes
Secondary	Other organ function (myocardial function, endothelial function, degree of inflammation)		Postoperative period	Yes