Sepsis Clinical Trial
Official title:
A Phase-IIa, Double-blind, Randomized, Placebo-controlled Study on the Safety and Early Efficacy of Alkaline Phosphatase in Sepsis Patients With Renal Failure
The purpose of this study is to investigate the safety and tolerability of AP in sepsis patients with renal failure and to investigate the effect of AP on inflammatory and clinical parameters in sepsis patients with renal failure.
RATIONALE FOR THE STUDY
A previous clinical study conducted in centers in The Netherlands and Belgium have shown a
substantial clinical benefit of AP treatment in patients with sepsis and associated acute
renal failure (see Introduction above). The latter results require confirmation in a
prospective study, as the current subject of this Protocol.
Choice of Drugs
The proposed study medication (AP) is identical to the study medication used in the previous
clinical study in sepsis patients with single or multiple end-organ failure. Since there is
no current proven treatment for these patients, the controls (as in previous studies) is
placebo.
Choice of patient population
The aim is to enroll a maximum of 26 patients positive for sepsis with an APACHE score of
≥20 and ≤28 (determined within 24 hours of entry), and who will be analyzed on an intention
to treat (ITT) basis.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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