Skip to content

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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00576849
Enrollment
50
Registered
2007-12-19
Start date
2007-12-31
Completion date
2010-05-31
Last updated
2010-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Elderly

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.

Interventions

DRUGBalanced 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

DRUG6% 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

Sponsors

Klinikum Ludwigshafen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
80 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients aged \>80 years

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The primary endpoint of the study is postoperative renal function28 days

Secondary

MeasureTime frame
Other organ function (myocardial function, endothelial function, degree of inflammation)Postoperative period

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026