Terlipressin in Septic Shock in Cirrhosis

NCT ID: NCT00628160

Last Updated: 2016-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2012-12-31

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.

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

Conditions

Liver Cirrhosis; Septic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Terlipressin group

Terlipressin in continuous infusion plus alpha adrenergic drugs (noradrenaline and/or dopamine in continuous infusion)

Group Type: EXPERIMENTAL

Terlipressin

Intervention Type: DRUG

Terlipressin 2-12 mg/24h intravenously in continuous infusion. Duration: until 24h after shock resolution.

Control group

Alpha adrenergic drugs (noradrenaline and/or dopamine in continuous infusion)

Group Type: ACTIVE_COMPARATOR

alpha adrenergic drugs

Intervention Type: DRUG

Dopamine (1-20 µg/Kg/min) and/or norepinephrine (0.05-4 µg/Kg/min) until shock resolution

Interventions

Terlipressin

Terlipressin 2-12 mg/24h intravenously in continuous infusion. Duration: until 24h after shock resolution.

Intervention Type: DRUG

alpha adrenergic drugs

Dopamine (1-20 µg/Kg/min) and/or norepinephrine (0.05-4 µg/Kg/min) until shock resolution

Intervention Type: DRUG

Other Intervention Names

Glypressin; Dopamine and/or norepinephrine

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Vicente Arroyo Perez

Senior Hepatologist Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Javier Fernandez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Vicente Arroyo, MD

Role: STUDY_DIRECTOR

Hospital Clinic of Barcelona

Locations

Hospital Clinic Barcelona

Barcelona, Catalonia, Spain

Countries

Spain

Other Identifiers

EUDRACAT-2005-000439-56

Identifier Type: -

Identifier Source: secondary_id

2005-000439-56

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

05-SS-JFDEZ-1

Identifier Type: -

Identifier Source: org_study_id