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Terlipressin in Septic Shock in Cirrhosis

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ClinicalTrials.gov Identifier: NCT00628160
Recruitment Status : Completed
First Posted : March 4, 2008
Last Update Posted : February 24, 2016
Information provided by (Responsible Party):
Vicente Arroyo Perez, Hospital Clinic of Barcelona

Brief Summary:

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 or disease Intervention/treatment Phase
Liver Cirrhosis Septic Shock Drug: Terlipressin Drug: alpha adrenergic drugs Phase 2 Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2006
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis Shock
Drug Information available for: Dopamine
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Hospital survival [ Time Frame: Hospitalization ]

Secondary Outcome Measures :
  1. Refractory shock [ Time Frame: ICU admission ]
  2. Variceal bleeding [ Time Frame: ICU admission ]
  3. Hepatorenal syndrome [ Time Frame: Hospitalization ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00628160

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

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
2005-000439-56 ( EudraCT Number )
First Posted: March 4, 2008    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We are currently writing the manuscript

Keywords provided by Vicente Arroyo Perez, Hospital Clinic of Barcelona:
Septic shock

Additional relevant MeSH terms:
Liver Cirrhosis
Shock, Septic
Pathologic Processes
Liver Diseases
Digestive System Diseases
Systemic Inflammatory Response Syndrome
Dopamine Agents
Adrenergic Agents
Cardiotonic Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Vasoconstrictor Agents
Antihypertensive Agents