Terlipressin in Septic Shock in Cirrhosis

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00628160
• Other study ID #: 05-SS-JFDEZ-1
• Secondary ID: EUDRACAT-2005-00
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 22, 2008
• Last updated: February 23, 2016
• Start date: October 2006
• Est. completion date: December 2012

Study information

• Verified date: February 2016
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Liver Cirrhosis
• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Terlipressin
Terlipressin 2-12 mg/24h intravenously in continuous infusion. Duration: until 24h after shock resolution.
• alpha adrenergic drugs
Dopamine (1-20 µg/Kg/min) and/or norepinephrine (0.05-4 µg/Kg/min) until shock resolution

Locations

Country	Name	City	State
Spain	Hospital Clinic Barcelona	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital survival		Hospitalization	Yes
Secondary	Refractory shock		ICU admission	No
Secondary	Variceal bleeding		ICU admission	No
Secondary	Hepatorenal syndrome		Hospitalization	No