Treatment of Hepatorenal Syndrome With Terlipressin Infusion Adjusted to Hemodynamic Response

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2016-12-31

Brief Summary

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Observe the effect of terlipressin on renal function in patients with SHR type I adjusting the dose based on hemodynamic response.

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Detailed Description

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Conditions

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Cirrhosis Hepatorenal Syndrome Type I

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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terlipressin

Group Type EXPERIMENTAL

Terlipressin and albumin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with hepatorenal syndrome type 1.
* Signed informed consent.

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.

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No