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OpenTrials
Completed

NCT Number: NCT00628160

Terlipressin in Septic Shock in Cirrhosis

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital Clinic Barcelona

Barcelona, Catalonia, 08036, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Terlipressin

Drug

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

Other names: Glypressin

alpha adrenergic drugs

Drug

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

Other names: Dopamine and/or norepinephrine

Primary outcomes

  1. Hospital survival

    Time frame: Hospitalization

Secondary outcomes

  1. Refractory shock

    Time frame: ICU admission

  2. Variceal bleeding

    Time frame: ICU admission

  3. Hepatorenal syndrome

    Time frame: Hospitalization

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Mar 4, 2008
Registry last updated
Feb 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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