NCT01017107

Activated Protein C in Severe Acute Pancreatitis

APCAP - Activated Protein C in Severe Acute Pancreatitis: A Double-blind Randomized Human Pilot Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study started in 2003 and was finished in 2007. The study was registered in The Helsinki University Central Hospital study register in 2003.

Conditions

• Acute Pancreatitis

Interventions

Type	Name	Description
DRUG	Activated protein C	24 micrograms/kg/hour intravenously for 96 hours

Timeline

• Start date: 2003-06-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2009-11-20
• Last updated: 2010-10-14

Locations

1 site across 1 country: Finland