Activated Protein C in Severe Acute Pancreatitis
Activated protein C (APC)has been shown to reduce mortality in severe sepsis(Bernard et al. 2001b). The clinical picture of severe acute pancreatitis (AP) is similar to that of sepsis. The investigators conducted a randomised double-blinded placebo-controlled pilot study in AP patients (16+16) with the same dose of APC that has been proven to be efficacious and safe in septic patients.
The aim of the study is to investigate whether the APC replacement therapy diminishes the occurrence and severity of organ dysfunction in patients with severe AP. The effect of APC on inflammatory and hemostatic parameters is also assessed.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||APCAP - Activated Protein C in Severe Acute Pancreatitis: A Double-blind Randomized Human Pilot Trial|
- The primary safety endpoint was the number of bleedings, and the primary efficacy endpoint was the change in SOFA between the start of the drug (day 0) and day 5. [ Time Frame: 0-60 days ] [ Designated as safety issue: Yes ]
- Organ failure free days alive [ Time Frame: 0-60 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2003|
|Study Completion Date:||September 2007|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
|Experimental: Activated protein C||
Drug: Activated protein C
24 micrograms/kg/hour intravenously for 96 hours
The study started in 2003 and was finished in 2007. The study was registered in The Helsinki University Central Hospital study register in 2003.
|Helsinki University Central Hospital|
|Helsinki, Finland, 00290|
|Principal Investigator:||Ville Pettilä, MD, PhD||Helsinki University Central Hospital|