Treatment of Hepatorenal Syndrome With Terlipressin Plus Albumin vs Albumin
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: NCT00287664
(because in a preliminary analysis we would need 1000 patients per group to achieve significative differences in the main end point.)
Hepatorenal syndrome is a common complication of cirrhotic patients. The prognosis of patients with HRS is very poor. It have been demonstrated that vasoconstrictors agents (Terlipressin) plus albumin are effective in the reversal of the treatment. However, previous studies are pilot studies and they are not able to give information about an improvement in survival. This comparative randomized study was delineated to test the efficacy of terlipressin on survival.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with HRS type 1 or 2 with serum creatinine >2 mg/dL
Age between 18 and 75 years
Written informed consent.
Absence of exclusion criteria
Hepatocarcinoma (3 nodules greater than 3 cm or 1 nodule > than 5 cm)
Active infection with systemic inflammatory response syndrome
Respiratory or cardiac dysfunction.
Arterial hypertension ( >140/90 mmHg during hospitalization )