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

February 22, 2008
February 23, 2016
October 2006
December 2012   (final data collection date for primary outcome measure)
Hospital survival [ Time Frame: Hospitalization ] [ Designated as safety issue: Yes ]
Hospital survival [ Time Frame: Hospitalization ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00628160 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Terlipressin in Septic Shock in Cirrhosis
Effects on Survival of Terlipressin Administration in Cirrhotic Patients With Severe Sepsis or Septic Shock. A Randomized, Open Labelled Controlled Trial

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.

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
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Liver Cirrhosis
  • Septic Shock
  • Drug: Terlipressin
    Terlipressin 2-12 mg/24h intravenously in continuous infusion. Duration: until 24h after shock resolution.
    Other Name: Glypressin
  • 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
  • Experimental: Terlipressin group
    Terlipressin in continuous infusion plus alpha adrenergic drugs (noradrenaline and/or dopamine in continuous infusion)
    Intervention: Drug: Terlipressin
  • Active Comparator: Control group
    Alpha adrenergic drugs (noradrenaline and/or dopamine in continuous infusion)
    Intervention: Drug: alpha adrenergic drugs
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00628160
05-SS-JFDEZ-1, EUDRACAT-2005-000439-56, 2005-000439-56
No
Yes
We are currently writing the manuscript
Vicente Arroyo Perez, Hospital Clinic of Barcelona
Hospital Clinic of Barcelona
Not Provided
Principal Investigator: Javier Fernandez, MD Hospital Clinic of Barcelona
Study Director: Vicente Arroyo, MD Hospital Clinic of Barcelona
Hospital Clinic of Barcelona
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP