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| Sponsor: | University of Turin, Italy |
|---|---|
| Information provided by: | University of Turin, Italy |
| ClinicalTrials.gov Identifier: | NCT00657306 |
Purpose
Relative adrenal insufficiency (RAI) is an well known condition in patients with septic shock. Liver failure (including chronic liver failure)and sepsis are both characterized by hyperdynamic circulatory failure (with low arterial pressure) and high levels of pro-inflammatory cytokines.
Hydrocortisone has been shown to have a beneficial effect on clinical outcome. The aim of this study is to evaluate the incidence of RAI in the different settings of ascites in cirrhosis and the usefulness of hydrocortisone in this context.
| Condition | Intervention | Phase |
|---|---|---|
|
Cirrhosis With Ascites |
Drug: hydrocortisone Drug: dextrose solution 5% |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Adrenal Insufficiency in Cirrhotics With Ascites. Effects of Stress Doses of Hydrocortisone on Renal Function and on Liver and Systemic Haemodynamics |
| Estimated Enrollment: | 50 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | May 2009 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Hydrocortisone, 50 mg/6 h per day
|
Drug: hydrocortisone
50 mg/6 h per day
|
|
2: Placebo Comparator
dextrose solution 5%
|
Drug: dextrose solution 5%
dextrose solution 5% 100 ml/6 h per day
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Carlo Alessandria, MD | 00390116335561 | carloalessandria@libero.it |
| Contact: Monica Carello, MD | 00390116335569 | monicacarello@virgilio.it |
| Italy | |
| San Giovanni Battista Hospital | |
| Turin, Italy, 10126 | |
| Principal Investigator: | Carlo Alessandria, MD | Division of gastroenterology and hepatology |
More Information
| Responsible Party: | Carlo Alessandria ( AOU San Giovanni Battista di Torino ) |
| Study ID Numbers: | AILD |
| Study First Received: | April 9, 2008 |
| Last Updated: | April 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00657306 History of Changes |
| Health Authority: | Italy: National Institute of Health |
|
Cirrhosis Ascites Adrenal insufficiency Hepatorenal syndrome Portal hypertension |
|
Anti-Inflammatory Agents Adrenal Insufficiency Liver Diseases Hydrocortisone Autoimmune Diseases Immune System Diseases Cortisol succinate Fibrosis Adrenal Gland Diseases |
Endocrine System Diseases Liver Cirrhosis Pharmacologic Actions Pathologic Processes Digestive System Diseases Ascites Therapeutic Uses Addison Disease Hydrocortisone acetate |
