NCT00576849

A Total Balanced Volume Replacement Regimen in Elderly Cardiac Surgery Patients

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Klinikum Ludwigshafen · Academic / Other
• Sex: All
• Age: 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Elderly
• Cardiac Surgery

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2007-12-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2007-12-19
• Last updated: 2010-05-27

Locations

1 site across 1 country: Germany