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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
36
placebo is administered intravenously over 48 hours. An initial loading dose of over 10-minutes is followed by continuous infusion over 48h.
AP is administered intravenously over 48 hours. An initial loading dose of 67.5U/Kg body weight over 10-minutes is followed by continuous infusion of 132.5U/Kg/24H administered over 48H
University Medical Center Antwerp (UZA)
Antwerp, Belgium
Cliniques Universitaires Saint Luc-UCL
Brussels, Belgium
ULB Hopital Erasme
Brussels, Belgium
Universitair Ziekenhuis Brussel
Brussels, Belgium
Haematology, biochemistry, and microbiological evaluation. Adverse event monitoring.
Time frame: 28 Days
To investigate the effect of AP on inflammatory parameters in sepsis patients with renal failure.
Time frame: 28 Days
To investigate the effect of AP on clinical variables in sepsis patients with renal failure.
Time frame: 28 Days
To investigate the effect of AP on renal function markers in sepsis patients with renal failure.
Time frame: 28 Days
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UMC Nijmegen University Medical Center St Radboud
Nijmegen, Gelderland, Netherlands
Isala Clinics
Zwolle, Overijssel, Netherlands
Jeroen Bosch Ziekenhuis lokatie GZG
's-Hertogenbosch, Netherlands
VU University Medical Center
Amsterdam, Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands