HydroCortisone in Severe Acute Pancreatitis
| ISRCTN | ISRCTN53054042 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53054042 |
| EudraCT/CTIS number | 2008-002346-30 |
| Secondary identifying numbers | EudraCT: 2008-002346-30 |
- 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
Scientific
Department of Gastroenterological Surgery
Meilahti Hospital
Haartmaninkatu 4
Helsinki
00029
Finland
Study information
| Study design | Multicentre randomised double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/12/2008 |
| 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 | Both |
| Target number of participants | Target: 150. Final: 4. |
| 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
00029
Finland
Sponsor information
Helsinki University Central Hospital (EVO) (Finland)
Hospital/treatment centre
Hospital/treatment centre
Department of Surgery
Meilahti Hospital
Haartmaninkatu 4
PL 340
Helsinki
00029
Finland
| Website | http://www.hus.fi/ |
|---|---|
"ROR" |
https://ror.org/02e8hzf44 |
Funders
Funder type
Hospital/treatment centre
Helsinki University Central Hospital (EVO) (Finland) - Research Funds
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
17/01/2019: The trial status has been changed to 'stopped'.
