Treatment of Type-1 Hepatorenal Syndrome Associated With Sepsis

NCT01932151 | Completed

• 1 other identifier: GIN-TER-2010-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Type 1 Hepatorenal syndrome (type-1 HRS) is a severe complication of patients with advanced cirrhosis characterized by marked renal failure and is associated with a very poor prognosis. Type-1 HRS is often precipitated by a bacterial infection, though it may occur spontaneously. It has been demonstrated that vasoconstrictor agents plus albumin are effective in the reversal of the renal failure. A large number of studies have shown that terlipressin improves renal function in patients with type 1 HRS; treatment is effective in 50-75% of patients approximately. Currently there are no specific studies about the treatment of type-1 HRS with ongoing infections.

Conditions

Hepatorenal Syndrome

Keywords

type-1 HRS; active bacterial infections; terlipressin and albumin; kidney function

Outcome Measures

Primary Outcomes (1)

• Change in serum creatinine values

  baseline and 14 days

Secondary Outcomes (4)

• changes in glomerular filtration rate

  at 3 days and 14 days

• Changes in arterial pressure

  baseline to 14 days

• changes in plasma renin activity

  at 3 days and 14 days

• changes in norepinephrine concentration

  at 3 days and 14 days

Other Outcomes (1)

• Presence of adverse effects

  14 days

Study Arms (1)

Terlipressin and albumin

OTHER

Single-group study (Type-1 Hepatorenal Syndrome Associated With Active Infections) Terlipressin was initially given at a dose of 1 mg/4h as an intravenous bolus for 2 days. If at day 3 serum creatinine had decreased at least 25% of the pretreatment values, the dose of terlipressin was not modified. In the remaining patients, the dose was increased up to a maximum of 2 mg/4h. Terlipressin was given until serum creatinine had decreased below 1.5 mg/dL (133 µmol/L) or for a maximum of 14 days.

Drug: Terlipressin and albumin

Interventions

Terlipressin and albumin DRUG

Single-group study (Type-1 Hepatorenal Syndrome Associated With Active Infections) Terlipressin was initially given at a dose of 1 mg/4h as an intravenous bolus for 2 days. If at day 3 serum creatinine had decreased at least 25% of the pretreatment values, the dose of terlipressin was not modified. In the remaining patients, the dose was increased up to a maximum of 2 mg/4h. Terlipressin was given until serum creatinine had decreased below 1.5 mg/dL (133 µmol/L) or for a maximum of 14 days. In addition to terlipressin, all patients received albumin at a dose of 1g per kg body weight during the first 24 hours, followed by 40g daily,targeted to obtain a central venous pressure (CVP) between 10 and 15 cm of water.

Also known as: - Glypressyn, Ferring SA, Saint-Prex, Switzerland., - Albúmina Humana Grífols, Grífols , Barcelona, Spain.

Terlipressin and albumin

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cirrhosis as diagnosed by liver biopsy or a combination of clinical, biochemical, ultrasonographic, and/or endoscopic findings.
• Age between 18 and 85 years.
• Presence of sepsis, as defined by active infection, and signs of Systemic Inflammatory Response Syndrome.
• Occurrence of type-1 HRS during the infection, as defined by standard diagnostic criteria.

You may not qualify if:

• Hepatocellular carcinoma outside the Milan criteria.
• Any severe extrahepatic condition, including cardiovascular, neurological, and organic kidney diseases.
• Septic or hypovolemic shock.
• Terminal condition (death expected in less than 48 hours).
• Lack of informed consent.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Hepatorenal Syndrome

Interventions

Terlipressin; Albumins

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Pere Ginès, MD

  Hospital Clinc of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Liver Unit

Study Record Dates

• First Submitted: August 14, 2013
• First Posted: August 30, 2013
• Study Start: December 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 5, 2013

Record last verified: 2013-09

Locations

ES (1)