Terlipressin in Septic Shock in Cirrhosis

Last updated: February 23, 2016
Sponsor: Hospital Clinic of Barcelona
Overall Status: Completed

Phase

2/3

Condition

Low Blood Pressure (Hypotension)

Sepsis And Septicemia

Hepatic Fibrosis

Treatment

N/A

Clinical Study ID

NCT00628160
05-SS-JFDEZ-1
EUDRACAT-2005-000439-56
2005-000439-56
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age between 18 and 80 years;

  2. Diagnosis of cirrhosis based on histology or on clinical, laboratory andultrasonographical data;

  3. Diagnosis of septic shock based on the presence of data compatible with systemicinflammatory response syndrome, a mean arterial pressure below 60 mmHg during morethan 1 hour despite adequate fluid resuscitation, and need for circulatory supportwith vasopressor drugs.

Exclusion

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 diseaseexcept for atrial fibrillation;

  4. Pregnancy;

  5. Advanced hepatocellular carcinoma (Milan criteria);

  6. Previous history of transplantation;

  7. Uncontrolled gastrointestinal bleeding.

Study Design

Total Participants: 72
Study Start date:
October 01, 2006
Estimated Completion Date:
December 31, 2012

Study 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

Connect with a study center

  • Hospital Clinic Barcelona

    Barcelona, Catalonia 08036
    Spain

    Site Not Available

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