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human albumin 5% · 1 trial · 1 indication
To assess the safety of HES 130/0.4 (Voluven) versus albumin 5% on renal function we will measure urinary concentrations of neutrophil gelatinase-associated lipocalin (NGAL), an important marker of renal function, measured at baseline (following anesthetic induction and prior to surgical incision), at one hour of arrival to intensive care unit (ICU), at 24 hours following completion of surgery.
| Arm | Type | Description |
|---|---|---|
| HES 130/0.4 (Voluven) | EXPERIMENTAL | 6% HES 130/0.4 during surgery |
| human albumin 5% | ACTIVE_COMPARATOR | human albumin 5% during surgery |
| Name | Type | Description |
|---|---|---|
| human albumin 5% | DRUG | - |
| HES 130/0.4 (Voluven) | DRUG | - |
Inclusion Criteria: * Age 50 - 85 years old * Scheduled for elective aortic valve replacement with or without coronary artery bypass grafting with or without additional minor surgical procedure. * Written, informed consent for participation in this investigation. Exclusion Criteria: * Patients wi...
Human albumin 5% is being studied for the prevention or treatment of postoperative kidney injury in cardiac surgical patients. It is a small molecule developed by Community Health Systems, Inc. (CYH) and is currently in Phase 3 clinical development as an investigational therapy.
Human albumin 5% does not target a specific molecular target. It is a plasma volume expander that works by increasing blood volume and improving hemodynamics, which may help protect kidney function after cardiac surgery. Its exact mechanism in preventing postoperative kidney injury is under investigation.
Human albumin 5% is being developed by Community Health Systems, Inc., a company traded under the ticker symbol CYH. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with postoperative kidney injury.
Human albumin 5% is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. A Phase 3 trial has been completed to assess its effects in cardiac surgical patients at risk for postoperative kidney injury.
Human albumin 5% has one completed Phase 3 trial, NCT02192502, titled 'Use of 6% Hydroxyethylstarch (130/0.4) in Cardiac Surgical Patients.' The trial enrolled 149 participants in the United States, with a minimum age of 40 years, and was randomized, double-blind, and active-controlled.
No, human albumin 5% is not the same as 6% hydroxyethylstarch. The clinical trial NCT02192502 compared human albumin 5% against 6% hydroxyethylstarch (130/0.4) as an active control. Human albumin 5% is a natural protein solution, while hydroxyethylstarch is a synthetic colloid.