NCT01530711

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2012

Longer than P75 for phase_4

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 18, 2016

Status Verified

August 1, 2016

Enrollment Period

4.7 years

First QC Date

February 9, 2012

Last Update Submit

August 17, 2016

Conditions

CirrhosisHepatorenal Syndrome Type I

Outcome Measures

Primary Outcomes (1)

  • Changes in arterial pressure and creatinine

    4 months

Secondary Outcomes (3)

  • Changes in plasmatic renin activity and aldosterone and noradrenaline concentration.

    4 months

  • Treatment-related adverse events

    4 months

  • Hepatorenal Syndrome reversion due to hemodynamic changes.

    4 months

Study Arms (1)

terlipressin

EXPERIMENTAL
Drug: Terlipressin and albumin

Interventions

Terlipressin and albuminDRUG

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.

terlipressin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hospital Clinic i Provincial de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Hospital del Mar

Barcelona, Barcelona, 08036, Spain

Location

Hospital Vall d´Hebron

Barcelona, Barcelona, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08041, Spain

Location

Corporació Sanitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Hospital Moisés Broggi

Sant Joan Despí, Barcelona, 08970, Spain

Location

MeSH Terms

Conditions

Fibrosis

Interventions

TerlipressinAlbumins

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LypressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 9, 2012

First Posted

February 10, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

August 18, 2016

Record last verified: 2016-08

Locations

ES(6)