Adrenal Insufficiency in Cirrhotics With Ascites. Effects of Hydrocortisone on Renal and Haemodynamic Function (AILD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00657306|
Recruitment Status : Unknown
Verified April 2008 by University of Turin, Italy.
Recruitment status was: Not yet recruiting
First Posted : April 14, 2008
Last Update Posted : April 14, 2008
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 or disease||Intervention/treatment||Phase|
|Cirrhosis With Ascites||Drug: hydrocortisone Drug: dextrose solution 5%||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Adrenal Insufficiency in Cirrhotics With Ascites. Effects of Stress Doses of Hydrocortisone on Renal Function and on Liver and Systemic Haemodynamics|
|Study Start Date :||May 2008|
|Estimated Primary Completion Date :||December 2008|
|Estimated Study Completion Date :||May 2009|
Hydrocortisone, 50 mg/6 h per day
50 mg/6 h per day
Placebo Comparator: 2
dextrose solution 5%
Drug: dextrose solution 5%
dextrose solution 5% 100 ml/6 h per day
- renal function [ Time Frame: 10 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00657306
|Contact: Carlo Alessandria, MDfirstname.lastname@example.org|
|Contact: Monica Carello, MDemail@example.com|
|San Giovanni Battista Hospital|
|Turin, Italy, 10126|
|Principal Investigator:||Carlo Alessandria, MD||Division of gastroenterology and hepatology|