Treatment of Hepatorenal Syndrome With Terlipressin Infusion Adjusted to Hemodynamic Response (AMELIORATE)
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ClinicalTrials.gov Identifier: NCT01530711 |
Recruitment Status : Unknown
Verified August 2016 by Pere Gines, Hospital Clinic of Barcelona.
Recruitment status was: Active, not recruiting
First Posted : February 10, 2012
Last Update Posted : August 18, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cirrhosis Hepatorenal Syndrome Type I | Drug: Terlipressin and albumin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Treatment of Hepatorenal Syndrome With Terlipressin Infusion Adjusted to Hemodynamic Response |
Study Start Date : | April 2012 |
Estimated Primary Completion Date : | December 2016 |
Estimated Study Completion Date : | December 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: terlipressin |
Drug: Terlipressin and albumin
Terlipressin dose: 2mg/24h, it will be modified depending on: Arterial pressure increase < 10 mmHg and the creatinine values decrease <25%, it will be increased every 8 hours until reaching an increase of at least 10mmHg arterial pressure or a creatinine decrease of the 25%. Albumin: Initial dose (first day) of 1g/Kg (up to a maximum of 100g) and the following days from 20 to 40 g/day. |
- Changes in arterial pressure and creatinine [ Time Frame: 4 months ]
- Changes in plasmatic renin activity and aldosterone and noradrenaline concentration. [ Time Frame: 4 months ]
- Treatment-related adverse events [ Time Frame: 4 months ]
- Hepatorenal Syndrome reversion due to hemodynamic changes. [ Time Frame: 4 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with hepatorenal syndrome type 1.
- Signed informed consent.
- No exclusion criteria.
- At least 18 years old
- Negative pregnancy test in serum or urine in women of childbearing age, and agree to use adequate contraception since at least 14 days prior to the first dose of study drug until 14 days after the last.
Exclusion Criteria:
- Hepatocellular carcinoma: exclusion of patients with hepatocellular carcinoma who present more than 3 nodules, single nodule larger than 5 cm, tumor portal thrombosis or extrahepatic tumor spread.
- Active bacterial infection with symptoms of systemic inflammatory response (fever, tachycardia, tachypnea, hypotension, septic or blood count).
- Cardiac or respiratory failure clinically significant.
- Clinically significant peripheral artery disease.
- A history of ischemic heart disease.
- Hypersensitivity to terlipressin and / or albumin or any of the excipients.
- Pregnancy.
- Septic shock.
- Chronic renal failure.
- Women in lactation

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): NCT01530711
Spain | |
Corporació Sanitària Parc Taulí | |
Sabadell, Barcelona, Spain, 08208 | |
Hospital Moisés Broggi | |
Sant Joan Despí, Barcelona, Spain, 08970 | |
Hospital Clinic i Provincial de Barcelona | |
Barcelona, Spain, 08036 | |
Hospital del Mar | |
Barcelona, Spain, 08036 | |
Hospital Vall d´Hebron | |
Barcelona, Spain, 08036 | |
Hospital de la Santa Creu i Sant Pau | |
Barcelona, Spain, 08041 |
Principal Investigator: | German Soriano Pastor, MD | gsoriano@santpau.cat | |
Principal Investigator: | Juan Cordoba, MD | jcordoba@vhebron.net | |
Principal Investigator: | Isabel Cirera Lorenzo, MD | ICirera@parcdesalutmar.cat | |
Principal Investigator: | Marta Martín Llahí, MD | martinllahi@gmail.com | |
Principal Investigator: | Jordi Sánchez Delgado, MD | jsanchezd@tauli.cat |
Responsible Party: | Pere Gines, MD, PhD, Hospital Clinic of Barcelona |
ClinicalTrials.gov Identifier: | NCT01530711 |
Other Study ID Numbers: |
AMELIORATE |
First Posted: | February 10, 2012 Key Record Dates |
Last Update Posted: | August 18, 2016 |
Last Verified: | August 2016 |
Hepatorenal Syndrome Syndrome Disease Pathologic Processes Liver Diseases Digestive System Diseases |
Kidney Diseases Urologic Diseases Terlipressin Antihypertensive Agents Vasoconstrictor Agents |