Overview

Treatment of Type I Hepatorenal Syndrome (HRS) With Pentoxyfylline

Status:
Terminated
Trial end date:
2017-12-31
Target enrollment:
0
Participant gender:
All
Summary
Pentoxyfylline therapy in addition to the standard of care of albumin, midodrine and octreotide therapy is superior to the standard of care alone in the treatment of Type I hepatorenal syndrome in the first 14 days of hospitalization.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Patrick Northup, MD
Treatments:
Pentoxifylline
Criteria
Inclusion Criteria:

- Hospitalized patients with acute or chronic liver disease

- Type I HRS

- Aged greater than or equal to 18

- Non-pregnant

Exclusion Criteria:

- Allergy or hypersensitivity to PTX or intolerance to methylxanthines (e.g. caffeine,
theophylline)

- Concurrent use of nephrotoxic drugs

- Age less than 18

- Pregnancy

- Uncontrolled bacterial infection

- Renal parenchymal disease (e.g. acute tubular necrosis, glomerular disease,
interstitial nephritis and urinary obstruction)

- Shock

- TNF alpha antagonist use

- Subject is institutionalized or a prisoner

- Recent cerebral or retinal hemorrhage (contraindication to PTX)

- Severe or poorly controlled cardiovascular disease as determined by the principal
investigator to hinder the ability to adhere to study protocols