HydroCortisone in Severe Acute Pancreatitis

Not Applicable

Completed

• Conditions: Acute pancreatitis; Digestive System

• Registration Number: ISRCTN53054042
• Lead Sponsor: Helsinki University Central Hospital (EVO) (Finland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-12-04
• Study Completion: 2012-10-31
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Patients with severe acute pancreatitis
2. Despite adequate fluid resuscitation (pulmonary capillary wedge pressure [PCWP] greater than 12 or central venous pressure [CVP] greater than 8 mmHg) presence of shock requiring vasopressor (norepinephrine greater than 0.2 µg/kg/min) support for at least one hour
3. Aged 18 to 65 years, both genders

Exclusion Criteria

1. Lack of written informed consent from patient or next of kin
2. Time from admission to hospital over seven days
3. Vasopressor support continued without interruption over 48 hours
4. Aged less than 18 years or greater than 65 years
5. Pregnancy or breastfeeding
6. More than two previous attacks of acute pancreatitis
7. Chronic pancreatitis or presence of complication after previous acute pancreatitis like pseudocyst
8. Hepatitis B, hepatitis C or human immunodeficiency (HIV) infection
9. Presence of acute infection (urinary, pulmonary, skin or soft-tissue infection)
10. Major abdominal, thoracic or vascular surgery within last 30 days
11. Severe chronic liver disease
12. Severe heart failure

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intensive Care Unit (ICU) free days within first 60 days after randomisation.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Survival without vasopressor support within 60 days after randomisation<br> 2. Requirement of vasopressor treatment (area under curve [AUC] of norepinephrine dose) for 5 days after randomisation<br> 3. Organ failure free time (days with Sepsis-related Organ Failure Assessment [SOFA]-score less than 5) within 60 days after randomisation<br> 4. Ventilator free days within 60 days after randomisation<br> 5. Days free from renal replacement therapy within 60 days after randomisation<br> 6. Mortality at day 28 and day 90 after admission to hospital<br> 7. Changes of inflammatory mediators, markers of coagulation and serum free cortisol during ICU stay<br> 8. Incidence of infected pancreatic necrosis<br>