A Total Balanced Volume Replacement Regimen in Elderly Cardiac Surgery Patients

Phase 4

Completed

• Conditions: Elderly; Cardiac Surgery
• Interventions: Drug: Balanced HES 130/0.42; Drug: 6% HES 130/0.4 prepared in saline solution

• Registration Number: NCT00576849
• Lead Sponsor: Klinikum Ludwigshafen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-18
• Study First Posted: 2007-12-19
• Status Verified: 2009-01
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Last Update Submitted: 2010-05-25
• Last Update Posted: 2010-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients aged >80 years

Exclusion Criteria

• Chronic kidney dysfunction requiring dialysis
• Myocardial infarction within the previous 3 weeks
• Liver insufficiency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Balanced HES 130/0.42	Total balanced volume replacement regimen consisting of a balanced HES 130/0.42 plus a balanced crystalloid
B	6% HES 130/0.4 prepared in saline solution	Conventional volume replacement strategy consisting of 6% HES 130/0.4 prepared in saline solution plus Ringer's lactate

Primary Outcome Measures

Name	Time	Method
The primary endpoint of the study is postoperative renal function	28 days

Secondary Outcome Measures

Name	Time	Method
Other organ function (myocardial function, endothelial function, degree of inflammation)	Postoperative period

Trial Locations

Locations (1)

Klinikum Ludwigshafen; 🇩🇪 Ludwigshafen, RLP, Germany