Additional identifiers
EudraCT number
2008-002346-30
ClinicalTrials.gov number
Protocol/serial number
EudraCT: 2008-002346-30
Study information
Scientific title
Supraphysiologic hydrocortisone in severe acute pancreatitis: a multicentre, randomised, double-blind, placebo-controlled trial
Acronym
HC-SAP
Study hypothesis
Supraphysiologic doses of hydrocortisone may result in earlier reversal of shock and thus lead to faster recovery from multiple organ dysfunction syndrome and better survival in patients with severe acute pancreatitis and shock.
Ethics approval
1. Ethics Committee of the Department of Surgery in the Hospital District of Helsinki and Uusimaa has approved study protocol on the 8th September 2008 (ref: 193/13/03/02/08)
2. National Agency for Medicines has approved study protocol on the 4th October 2008 (KLnro: 108/2008)
Study design
Multicentre randomised double-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Acute pancreatitis
Intervention
Continuous intravenous infusion of hydrocortisone 300 mg/24 hours for 5 days, then 150 mg/24 hours for 3 days and then 50 mg/24 hours for 4 days. Placebo group receives infusion of comparable volume of physiologic saline for 12 days. Venous blood samples are collected before start of intervention and on days 1, 2, 3, 4, 5, 7, 14, 21 and 28 after randomisation.
Intervention type
Drug
Phase
Not Specified
Drug names
Hydrocortisone
Primary outcome measure
Intensive Care Unit (ICU) free days within first 60 days after randomisation.
Secondary outcome measures
1. Survival without vasopressor support within 60 days after randomisation
2. Requirement of vasopressor treatment (area under curve [AUC] of norepinephrine dose) for 5 days after randomisation
3. Organ failure free time (days with Sepsis-related Organ Failure Assessment [SOFA]-score less than 5) within 60 days after randomisation
4. Ventilator free days within 60 days after randomisation
5. Days free from renal replacement therapy within 60 days after randomisation
6. Mortality at day 28 and day 90 after admission to hospital
7. Changes of inflammatory mediators, markers of coagulation and serum free cortisol during ICU stay
8. Incidence of infected pancreatic necrosis
Overall trial start date
01/12/2008
Overall trial end date
31/10/2012
Reason abandoned (if study stopped)
Participant recruitment issue
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Target: 150. Final: 4.
Participant 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
Recruitment start date
01/12/2008
Recruitment end date
31/10/2012
Locations
Countries of recruitment
Finland
Trial participating centre
Department of Gastroenterological Surgery
Helsinki
00029
Finland
Sponsor information
Organisation
Helsinki University Central Hospital (EVO) (Finland)
Sponsor details
Department of Surgery
Meilahti Hospital
Haartmaninkatu 4
PL 340
Helsinki
00029
Finland
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Helsinki University Central Hospital (EVO) (Finland) - Research Funds
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list