A Study 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.
Bacterial Infections and Mycoses
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|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|
- Haematology, biochemistry, and microbiological evaluation. Adverse event monitoring. [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]
- To investigate the effect of AP on inflammatory parameters in sepsis patients with renal failure. [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
- To investigate the effect of AP on clinical variables in sepsis patients with renal failure. [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
- To investigate the effect of AP on renal function markers in sepsis patients with renal failure. [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
|Study Start Date:||May 2008|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Experimental: Bovine Intestinal AP
Bovine Intestinal Alkaline Phosphatase (BIAP) Intravenous administration of 10" bolus (67,5U/kg) and 48h continuous infusion (132,5U/kg)
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
Placebo Comparator: 2
Placebo Intravenous administration of 10" bolus and 48h continuous infusion
placebo is administered intravenously over 48 hours. An initial loading dose of over 10-minutes is followed by continuous infusion over 48h.
Other Name: Placebo
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.
|University Medical Center Antwerp (UZA)|
|Universitair Ziekenhuis Brussel|
|Cliniques Universitaires Saint Luc-UCL|
|ULB Hopital Erasme|
|UMC Nijmegen University Medical Center St Radboud|
|Nijmegen, Gelderland, Netherlands, 6500 HB|
|Zwolle, Overijssel, Netherlands, 8011 JW|
|Jeroen Bosch Ziekenhuis lokatie GZG|
|VU University Medical Center|
|Canisius Wilhelmina Ziekenhuis|
|Principal Investigator:||Professor J G van der Hoeven, MD, PhD||University Medical Center St Radboud, Nijmegen, The Netherlands|