Terlipressin in Septic Shock in Cirrhosis

Condition(s) targeted: Liver Cirrhosis; Septic Shock

Intervention: Terlipressin plus alpha adrenergic drugs (Drug); alpha adrenergic drugs (Dopamine and/or norepinephrine) (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Hospital Clinic of Barcelona

Official(s) and/or principal investigator(s):
Javier Fernandez, MD, Principal Investigator, Affiliation: Hospital Clinic of Barcelona
Vicente Arroyo, MD, Study Director, Affiliation: Hospital Clinic of Barcelona

Overall contact:
Javier Fernandez, MD, Phone: 003493652421887, Email: Jfdez@clinic.ub.es

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.

Official title: Effects on Survival of Terlipressin Administration in Cirrhotic Patients With Severe Sepsis or Septic Shock. A Randomized, Open Labelled Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Hospital survival

Secondary outcome:

Refractory shock

Variceal bleeding

Hepatorenal syndrome

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Javier Fernandez, MD, Phone: 003493652421887, Email: Jfdez@clinic.ub.es

Hospital Clinic Barcelona, Barcelona, Catalonia 08036, Spain; Recruiting
Javier Fernandez, MD, Phone: 0034932275400, Ext: 4030, Email: Jfdez@clinic.ub.es
Javier Fernandez, MD, Principal Investigator
Pere Gines, MD, Sub-Investigator
Antoni Mas, MD, Sub-Investigator

Starting date: October 2006
Last updated: March 3, 2008