Acute Pancreatitis
Conditions
Keywords
acute pancreatitis, treatment, organ failure, activated protein c
Brief 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.
Interventions
24 micrograms/kg/hour intravenously for 96 hours
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Admitted to hospital within 72 h of the onset of pain. * Plasma amylase concentration more than three times the upper limit of the normal range and/or CT findings compatible with AP. * Organ failure and \<48h of the onset of the first organ failure
Exclusion criteria
* HIV / B- or C hepatitis infection * Pregnancy or breast feeding * Active bleeding * Increased risk of bleeding (thrombocytes \<30x10E9/L or INR\>3.0 * Gastrointestinal bleeding within 6 weeks or intracranial stroke within 3 months before the study * Intravenous contrast extravasation or other signs (fresh hematoma) suggesting active hemorrhage within the pancreas or in the peripancreatic area on admission CT scan * Use of antithrombin III within 12 h * Use of acetylsalicylic acid or glycoprotein IIB/IA antagonist within 7 days / Thrombolytic therapy within 3 days * Surgery requiring general or spinal anaesthesia within 12 h * Previous pancreatic surgery * Application of an epidural catheter within 48 h
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 0-60 days |
Secondary
| Measure | Time frame |
|---|---|
| Organ failure free days alive | 0-60 days |
Countries
Finland
Outcome results
None listed