Tetraspan 6 Percent (%) Combined With Sterofundin ISO Versus Albumin 5 Percent (%) Combined With Sodium Chloride (NaCL)

B. Braun

Status and phase

Terminated

Phase 4

Conditions

Renal Insufficiency

Treatments

Drug: Albumin + electrolyte solution

Drug: HES 130/0.42 + electrolyte solution

Study type

Interventional

Funder types

Industry

Identifiers

HC-G-H-0514

Details and patient eligibility

About

This investigational study will investigate two different volume replacement regimes in patients suffering from compromised renal function.

Enrollment

2 patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

male or female patients
≥ 50 years of age;
patients with compromised renal function, i.e. serum creatinine between 1.5 mg/dl and 3.0 mg/dl;
patients scheduled for elective intervention;
patients with an estimated intraoperative volume need of at least 1 l colloids;
provision of voluntary informed consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Ethics Committee (IEC) prior to all evaluations

Exclusion:

patients of ASA-class > III;
patients with daily urine output < 1 l;
patients on haemodialysis;
patients receiving HES during the last 48 hours before first infusion of the investigational products;
patients suffering from coagulation disorders (i.e. PTT > 60 sec);
patients with a hemoglobin < 9 g/dl;
patients with known hypersensitivity to HES, albumin or any of the excipients;
patients suffering from contraindications of the investigational products (i.e. hyperhydration state including pulmonary oedema, renal failure with oliguria or anuria, intracranial haemorrhage, hyperkalaemia, severe hypernatraemia or severe hyperchloraemia, severely impaired hepatic function, congestive heart failure);
simultaneous participation in another clinical trial; emergencies;
patients scheduled for brain surgery;
patients incapable to give informed consent (e.g. patients with dementia, psychiatric diseases or suffering from conditions associated with lack of consciousness)