Condition category
Digestive System
Date applied
15/10/2008
Date assigned
04/12/2008
Last edited
04/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Esko Kemppainen

ORCID ID

Contact details

Department of Gastroenterological Surgery
Meilahti Hospital
Haartmaninkatu 4
Helsinki
00029
Finland

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 measures

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

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

150

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

http://www.hus.fi/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes