Terlipressin in Septic Shock in Cirrhosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vicente Arroyo Perez, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00628160
First received: February 22, 2008
Last updated: February 23, 2016
Last verified: February 2016
  Purpose

Septic shock is a frequent and severe complication in cirrhosis. Current mortality rate ranges between 50 and 80% of cases. Refractory shock, hepatorenal failure and variceal bleeding are the main causes of death of these patients. Terlipressin administration could prevent these complications and improve survival in this setting.

Aim: To evaluate the effects of terlipressin administration on hospital survival in cirrhotic patients with severe sepsis or septic shock.

Methods: Prospective, open labelled, controlled trial evaluating 72 cirrhotic patients with severe sepsis or septic shock who will be randomized to receive terlipressin plus alpha-adrenergic drugs or only alpha-adrenergic drugs at shock diagnosis. Patients will be submitted to continuous systemic hemodynamic monitoring (S. Ganz catheter or Vigileo). Changes in vasoactive systems and cytokines levels will be also evaluated.


Condition Intervention Phase
Liver Cirrhosis
Septic Shock
Drug: Terlipressin
Drug: alpha adrenergic drugs
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects on Survival of Terlipressin Administration in Cirrhotic Patients With Severe Sepsis or Septic Shock. A Randomized, Open Labelled Controlled Trial

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Hospital survival [ Time Frame: Hospitalization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Refractory shock [ Time Frame: ICU admission ] [ Designated as safety issue: No ]
  • Variceal bleeding [ Time Frame: ICU admission ] [ Designated as safety issue: No ]
  • Hepatorenal syndrome [ Time Frame: Hospitalization ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: October 2006
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Terlipressin group
Terlipressin in continuous infusion plus alpha adrenergic drugs (noradrenaline and/or dopamine in continuous infusion)
Drug: Terlipressin
Terlipressin 2-12 mg/24h intravenously in continuous infusion. Duration: until 24h after shock resolution.
Other Name: Glypressin
Active Comparator: Control group
Alpha adrenergic drugs (noradrenaline and/or dopamine in continuous infusion)
Drug: alpha adrenergic drugs
Dopamine (1-20 µg/Kg/min) and/or norepinephrine (0.05-4 µg/Kg/min) until shock resolution
Other Name: Dopamine and/or norepinephrine

Detailed Description:
Prospective, open labelled, RCT evaluating 72 cirrhotic patients with severe sepsis or septic shock (36 per arm) who were randomized to receive terlipressin plus alpha-adrenergic drugs or alpha-adrenergic drugs in the first 24h after septic shock diagnosis. Impact of terlipressin administration on shock reversal, changes in vasoactive systems, inflammatory response, incidence of variceal bleeding and type-1 HRS and ICU and hospital mortality was investigated
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 18 and 80 years;
  2. Diagnosis of cirrhosis based on histology or on clinical, laboratory and ultrasonographical data;
  3. Diagnosis of septic shock based on the presence of data compatible with systemic inflammatory response syndrome, a mean arterial pressure below 60 mmHg during more than 1 hour despite adequate fluid resuscitation, and need for circulatory support with vasopressor drugs.

Exclusion Criteria:

  1. More than 24 hours of evolution of the shock;
  2. Cardiac index < 2,5 l/min;
  3. History of HIV infection or clinically relevant pulmonary, renal or cardiac disease except for atrial fibrillation;
  4. Pregnancy;
  5. Advanced hepatocellular carcinoma (Milan criteria);
  6. Previous history of transplantation;
  7. Uncontrolled gastrointestinal bleeding.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00628160

Locations
Spain
Hospital Clinic Barcelona
Barcelona, Catalonia, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Principal Investigator: Javier Fernandez, MD Hospital Clinic of Barcelona
Study Director: Vicente Arroyo, MD Hospital Clinic of Barcelona
  More Information

Responsible Party: Vicente Arroyo Perez, Senior Hepatologist Consultant, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00628160     History of Changes
Other Study ID Numbers: 05-SS-JFDEZ-1  EUDRACAT-2005-000439-56  2005-000439-56 
Study First Received: February 22, 2008
Last Updated: February 23, 2016
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:
Septic shock
Cirrhosis
Survival

Additional relevant MeSH terms:
Liver Cirrhosis
Shock
Shock, Septic
Digestive System Diseases
Infection
Inflammation
Liver Diseases
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome
Adrenergic Agents
Dopamine
Dopamine Agents
Lypressin
Norepinephrine
Terlipressin
Adrenergic Agonists
Adrenergic alpha-Agonists
Antidiuretic Agents
Antihypertensive Agents
Autonomic Agents
Cardiotonic Agents
Coagulants
Hemostatics
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on May 25, 2016