Treatment of Hepatorenal Syndrome With Terlipressin Plus Albumin vs Albumin
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ClinicalTrials.gov Identifier: NCT00287664 |
Recruitment Status :
Suspended
(because in a preliminary analysis we would need 1000 patients per group to achieve significative differences in the main end point.)
First Posted : February 7, 2006
Last Update Posted : April 11, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cirrhosis Hepatorenal Syndrome | Drug: terlipressin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Terlipressin as Treatment of Patients With Cirrhosis and Hepatorenal Syndrome. Effect on Survival and Renal Function. Multicenter, Randomized and Prospective Study |
Study Start Date : | February 2002 |
Study Completion Date : | September 2006 |

- Survival

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
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.
- Arteriopathy.
- Ischemic cardiopathy.
- Arterial hypertension ( >140/90 mmHg during hospitalization )

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): NCT00287664
Spain | |
Hospital Clinic | |
Barcelona, Spain, 08036 |
Principal Investigator: | Pere Gines, MD | Chair of Liver Unit |
ClinicalTrials.gov Identifier: | NCT00287664 |
Other Study ID Numbers: |
TAHRS |
First Posted: | February 7, 2006 Key Record Dates |
Last Update Posted: | April 11, 2007 |
Last Verified: | April 2007 |
hepatorenal syndrome terlipressin albumin cirrhosis |
Liver Cirrhosis Hepatorenal Syndrome Syndrome Fibrosis Disease Pathologic Processes Liver Diseases |
Digestive System Diseases Kidney Diseases Urologic Diseases Terlipressin Antihypertensive Agents Vasoconstrictor Agents |