HydroCortisone in Severe Acute Pancreatitis

ISRCTN	ISRCTN53054042
DOI	https://doi.org/10.1186/ISRCTN53054042
Clinical Trials Information System (CTIS)	2008-002346-30
Protocol serial number	EudraCT: 2008-002346-30
Sponsor	Helsinki University Central Hospital (EVO) (Finland)
Funder	Helsinki University Central Hospital (EVO) (Finland) - Research Funds

Submission date: 15/10/2008
Registration date: 04/12/2008
Last edited: 17/01/2019

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Esko Kemppainen
Scientific

Department of Gastroenterological Surgery
Meilahti Hospital
Haartmaninkatu 4
Helsinki
00029
Finland

Study information

Primary study design	Interventional
Study design	Multicentre randomised double-blind placebo-controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Supraphysiologic hydrocortisone in severe acute pancreatitis: a multicentre, randomised, double-blind, placebo-controlled trial
Study acronym	HC-SAP
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Hydrocortisone
Primary outcome measure(s)	Intensive Care Unit (ICU) free days within first 60 days after randomisation.
Key secondary outcome measure(s)	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
Completion date	31/10/2012
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	150
Key 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
Key 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
Date of first enrolment	01/12/2008
Date of final enrolment	31/10/2012

Locations

Countries of recruitment

Finland

Study participating centre

Department of Gastroenterological Surgery

Helsinki
00029
Finland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

17/01/2019: The trial status has been changed to 'stopped'.