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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.
Full description
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.
Enrollment
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Inclusion criteria
Patients between the age of 18 and 80 years.
Proven or suspected infection.
Two out of four SIRS criteria of systemic inflammation, existing for less than 24 hours after admission in the intensive care unit, as follows:
Acute renal failure, defined as
Written informed consent obtained prior to any study intervention.
Exclusion criteria
Primary purpose
Allocation
Interventional model
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36 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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