Terlipressin in Septic Shock in Cirrhosis - Full Text View

Sponsored by:	Hospital Clinic of Barcelona
Information provided by:	Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:	NCT00628160

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 II Phase III

MedlinePlus related topics: Cirrhosis Sepsis

Drug Information available for: Dopamine Dopamine hydrochloride Norepinephrine Norepinephrine bitartrate Terlipressin

U.S. FDA Resources

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

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
1: Experimental 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. 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
2: Active Comparator 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:

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.

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, Catalonia
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

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

Keywords provided by Hospital Clinic of Barcelona:

Septic shock
Cirrhosis
Survival

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Liver Diseases
Sepsis
Dopamine
Digestive System Diseases
Shock

Fibrosis
Norepinephrine
Terlipressin
Shock, Septic
Liver Cirrhosis
Inflammation

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Sympathomimetics
Physiological Effects of Drugs
Cardiovascular Agents
Antihypertensive Agents

Infection
Adrenergic Agonists
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Vasoconstrictor Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009