Terlipressin in Septic Shock in Cirrhosis

NCT00628160 | Completed Phase 2

• 3 other identifiers: 05-SS-JFDEZ-1EUDRACAT-2005-000439-562005-000439-56
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis; Septic Shock

Keywords

Septic shock; Cirrhosis; Survival

Outcome Measures

Primary Outcomes (1)

• Hospital survival

  Hospitalization

Secondary Outcomes (3)

• Refractory shock

  ICU admission

• Variceal bleeding

  ICU admission

• Hepatorenal syndrome

  Hospitalization

Study Arms (2)

Terlipressin group

EXPERIMENTAL

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

Drug: Terlipressin

Control group

ACTIVE COMPARATOR

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

Drug: alpha adrenergic drugs

Interventions

Terlipressin DRUG

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

Also known as: Glypressin

Terlipressin group

alpha adrenergic drugs DRUG

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

Also known as: Dopamine and/or norepinephrine

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 80 years;
• Diagnosis of cirrhosis based on histology or on clinical, laboratory and ultrasonographical data;
• 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.

You may not qualify if:

• More than 24 hours of evolution of the shock;
• Cardiac index \< 2,5 l/min;
• History of HIV infection or clinically relevant pulmonary, renal or cardiac disease except for atrial fibrillation;
• Pregnancy;
• Advanced hepatocellular carcinoma (Milan criteria);
• Previous history of transplantation;
• Uncontrolled gastrointestinal bleeding.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic Barcelona

Barcelona, Catalonia, 08036, Spain

Location

MeSH Terms

Conditions

Liver Cirrhosis; Shock, Septic; Fibrosis

Interventions

Terlipressin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock

Intervention Hierarchy (Ancestors)

Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Javier Fernandez, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

• Vicente Arroyo, MD

  Hospital Clinic of Barcelona

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Hepatologist Consultant

Study Record Dates

• First Submitted: February 22, 2008
• First Posted: March 4, 2008
• Study Start: October 1, 2006
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 24, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)