A Total Balanced Volume Replacement Regimen in Elderly Cardiac Surgery Patients

Klinikum Ludwigshafen

Status and phase: Completed; Phase 4

Conditions: Cardiac Surgery; Elderly

Treatments: Drug: Balanced HES 130/0.42; Drug: 6% HES 130/0.4 prepared in saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT00576849

HES2007

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 80+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged >80 years

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

A

Experimental group

Description:

Total balanced volume replacement regimen consisting of a balanced HES 130/0.42 plus a balanced crystalloid

Treatment:

Drug: Balanced HES 130/0.42

Drug: Balanced HES 130/0.42

B

Active Comparator group

Description:

Conventional volume replacement strategy consisting of 6% HES 130/0.4 prepared in saline solution plus Ringer's lactate

Treatment:

Drug: 6% HES 130/0.4 prepared in saline solution