Liver CirrhosisPhase 2/3NCT00628160
Terlipressin in Septic Shock in Cirrhosis
A Phase 2/3 study testing Terlipressin and alpha adrenergic drugs in people with Liver Cirrhosis and Septic Shock, run by Hospital Clinic of Barcelona at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cirrhosis, Septic Shock
- What is being tested?
- Terlipressin and alpha adrenergic drugs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2006to Dec 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects on Survival of Terlipressin Administration in Cirrhotic Patients With Severe Sepsis or Septic Shock. A Randomized, Open Labelled Controlled Trial
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.
Read the 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
- Conditions
- Liver Cirrhosis, Septic Shock
- Being tested
- Terlipressin, alpha adrenergic drugs
- Keywords
- Septic shock, Cirrhosis, Survival
- Medical subject headings
- Liver Cirrhosis, Shock, Septic, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerlipressinDrug
Also called Glypressin
Terlipressin 2-12 mg/24h intravenously in continuous infusion. Duration: until 24h after shock resolution.
alpha adrenergic drugsDrug
Also called Dopamine and/or norepinephrine
Dopamine (1-20 µg/Kg/min) and/or norepinephrine (0.05-4 µg/Kg/min) until shock resolution
| Study group | Role | What they receive |
|---|---|---|
| Terlipressin group | Experimental | Terlipressin in continuous infusion plus alpha adrenergic drugs (noradrenaline and/or dopamine in continuous infusion) Receives: Drug: Terlipressin |
| Control group | Active comparator | Alpha adrenergic drugs (noradrenaline and/or dopamine in continuous infusion) Receives: Drug: alpha adrenergic drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital survival
Measured: Hospitalization
Secondary outcomes (3)
Refractory shock
Measured: ICU admission
Variceal bleeding
Measured: ICU admission
Hepatorenal syndrome
Measured: Hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2008 (estimated)
- Study startOct 2006
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vicente Arroyo Perez, Hospital Clinic of Barcelona
- Investigators
- Javier Fernandez, MD, Principal investigator, Hospital Clinic of BarcelonaVicente Arroyo, MD, Study director, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628160
- Sponsor's protocol ID
- 05-SS-JFDEZ-1
- Other IDs
- EUDRACAT-2005-000439-56, 2005-000439-56, 2005
- Status last verified
- Feb 2016
- First submitted
- 22 Feb 2008
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: We are currently writing the manuscript
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Survival of Terlipressin Administration in Cirrhotic Patients With Severe Sepsis or Septic Shock. A Randomized, Open Labelled Controlled Trial
- ClinicalTrials.gov ID
- NCT00628160
- Acronym / sponsor ID
- 05-SS-JFDEZ-1
- Conditions
- Liver Cirrhosis, Septic Shock
- Keywords
- Septic shock, Cirrhosis, Survival
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 4 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Terlipressin group | Experimental | Drug: TerlipressinTerlipressin in continuous infusion plus alpha adrenergic drugs (noradrenaline and/or dopamine in continuous infusion) |
| Control group | Active comparator | Drug: alpha adrenergic drugsAlpha adrenergic drugs (noradrenaline and/or dopamine in continuous infusion) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TerlipressinAlso: GlypressinTerlipressin 2-12 mg/24h intravenously in continuous infusion. Duration: until 24h after shock resolution. | Drug | Terlipressin group |
| alpha adrenergic drugsAlso: Dopamine and/or norepinephrineDopamine (1-20 µg/Kg/min) and/or norepinephrine (0.05-4 µg/Kg/min) until shock resolution | Drug | Control group |
Primary outcome
Hospital survival
Time frame: Hospitalization
3 secondary outcomes
Refractory shock
Time frame: ICU admission
Variceal bleeding
Time frame: ICU admission
Hepatorenal syndrome
Time frame: Hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
- Individual participant dataSharing planned: Yes. We are currently writing the manuscript
Related trials for Liver Cirrhosis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Fernandez, MD principal investigator
Hospital Clinic of Barcelona
Vicente Arroyo, MD study director
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Terlipressin and alpha adrenergic drugs in people with Liver Cirrhosis and Septic Shock, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital survival (time frame: Hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2016.