Terlipressin in Septic Shock in Cirrhosis

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00628160

Enrollment

Registered

2008-03-04

Start date

2006-10-31

Completion date

2012-12-31

Last updated

2016-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis, Septic Shock

Keywords

Septic shock, Cirrhosis, Survival

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

Interventions

DRUGTerlipressin

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

DRUGalpha adrenergic drugs

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Hospital survival	Hospitalization

Secondary

Measure	Time frame
Refractory shock	ICU admission
Variceal bleeding	ICU admission
Hepatorenal syndrome	Hospitalization

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026