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Terlipressin in Septic Shock in Cirrhosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Hospital Clinic of Barcelona.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00628160
First received: February 22, 2008
Last updated: March 3, 2008
Last verified: February 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Liver Cirrhosis
Septic Shock
 Drug: Terlipressin plus alpha adrenergic drugs
Drug: alpha adrenergic drugs (Dopamine and/or norepinephrine)
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects on Survival of Terlipressin Administration in Cirrhotic Patients With Severe Sepsis or Septic Shock. A Randomized, Open Labelled Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis Sepsis Shock
U.S. FDA Resources

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Hospital survival [ Time Frame: Hospitalization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Refractory shock [ Time Frame: ICU admission ] [ Designated as safety issue: No ]
  • Variceal bleeding [ Time Frame: ICU admission ] [ Designated as safety issue: No ]
  • Hepatorenal syndrome [ Time Frame: Hospitalization ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: October 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Terlipressin plus alpha adrenergic drugs
 Drug: Terlipressin plus alpha adrenergic drugs
Terlipressin 1, 1.5 and 2 mg/4h intravenously in patients with body weight < 50 kg, between 50 and 70 Kg and > 70 Kg respectively. Duration: until 24h after shock resolution.
Other Name: Glypressin
Drug: alpha adrenergic drugs (Dopamine and/or norepinephrine)
Dopamine (1-20 µg/Kg/min) and/or norepinephrine (0.05-4 µg/Kg/min) until shock resolution
Active Comparator: 2
Alpha adrenergic drugs
 Drug: alpha adrenergic drugs (Dopamine and/or norepinephrine)
Dopamine (1-20 µg/Kg/min) and/or norepinephrine (0.05-4 µg/Kg/min) until shock resolution

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00628160

Contacts
Contact: Javier Fernandez, MD 003493652421887 Jfdez@clinic.ub.es

Locations
Spain
Hospital Clinic Barcelona Recruiting
Barcelona, Catalonia, Spain, 08036
Contact: Javier Fernandez, MD     0034932275400 ext 4030     Jfdez@clinic.ub.es    
Principal Investigator: Javier Fernandez, MD            
Sub-Investigator: Pere Gines, MD            
Sub-Investigator: Antoni Mas, MD            
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Principal Investigator: Javier Fernandez, MD Hospital Clinic Barcelona
Study Director: Vicente Arroyo, MD Hospital Clinic Barcelona
  More Information

No publications provided

Responsible Party: Vicente Arroyo Perez, Liver Unit. Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00628160     History of Changes
Other Study ID Numbers: 05-SS-JFDEZ-1, EUDRACAT-2005-000439-56
Study First Received: February 22, 2008
Last Updated: March 3, 2008
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:
Septic shock
Cirrhosis
Survival

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Shock
Shock, Septic
Liver Diseases
Digestive System Diseases
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Adrenergic Agents
Norepinephrine
Dopamine
Dopamine Agents
 Terlipressin
Lypressin
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Protective Agents
Vasoconstrictor Agents
Adrenergic alpha-Agonists

ClinicalTrials.gov processed this record on June 18, 2013