Septic ShockPhase 2NCT00793559
Terlipressin Administration in Septic Shock Refractory to Catecholamines
A Phase 2 study testing terlipressin in people with Septic Shock, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
terlipressin is given to refractory septic shock patients who do not respond to noradrenalin in Israel and Europe. It is given by bolus injection. we attempt to investigate weather it is better to give it by continuous drip and avoid abrupt changes in BP and heart function Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- terlipressin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2008to Jul 2009
- Phase
- Phase 2
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- septic shock patients receiving above 0.5 mcg/kg NA
Who cannot join
- allergy to terlipressin, CHF, IHD, pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Terlipressin Administration in Septic Shock Refractory to Catecholamines Bolus vs. Continuous Drip-Phase II
terlipressin is given to refractory septic shock patients who do not respond to noradrenalin in Israel and Europe. It is given by bolus injection. we attempt to investigate weather it is better to give it by continuous drip and avoid abrupt changes in BP and heart function
- Conditions
- Septic Shock
- Being tested
- terlipressin
- Keywords
- septic shock refractory to catecholamines
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
terlipressinDrug
Also called glypressin
1 mg of terlipressin one time only
terlipressinDrug
1 mg of terlipressin in 50 cc of NS given at a drip of a total of 6 h
| Study group | Role | What they receive |
|---|---|---|
| terlipressin bolus | Active comparator | 1 mg of terlipressin received one time only Receives: Drug: terlipressin |
| terlipressin drip | Experimental | Not described Receives: Drug: terlipressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
CI, SVR,HR,BP, noradrenalin administration,renal function
Measured: 6 mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionJul 2009 (estimated)
- Study completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- Tal Mann, Dr, Study director, Asaf Harofeh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793559
- Sponsor's protocol ID
- 161/08
- Status last verified
- Nov 2008
- First submitted
- 18 Nov 2008
- Last updated
- 19 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Terlipressin Administration in Septic Shock Refractory to Catecholamines Bolus vs. Continuous Drip-Phase II
- ClinicalTrials.gov ID
- NCT00793559
- Acronym / sponsor ID
- 161/08
- Conditions
- Septic Shock
- Keywords
- septic shock refractory to catecholamines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Nov 2008
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 19 Nov 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.
terlipressin is given to refractory septic shock patients who do not respond to noradrenalin in Israel and Europe. It is given by bolus injection. we attempt to investigate weather it is better to give it by continuous drip and avoid abrupt changes in BP and heart function
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| terlipressin bolus | Active comparator | Drug: terlipressin1 mg of terlipressin received one time only |
| terlipressin drip | Experimental | Drug: terlipressin |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- septic shock patients receiving above 0.5 mcg/kg NA
Key exclusion criteria (1 listed)
- allergy to terlipressin, CHF, IHD, pregnancy
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: glypressin1 mg of terlipressin one time only | Drug | terlipressin bolus |
| terlipressin1 mg of terlipressin in 50 cc of NS given at a drip of a total of 6 h | Drug | terlipressin drip |
Primary outcome
CI, SVR,HR,BP, noradrenalin administration,renal function
Time frame: 6 mo
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2008.
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Septic Shock
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.
Tal Mann, Dr study director
Asaf Harofeh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing terlipressin in people with Septic Shock, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Nov 2008. 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 Israel. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tal Mann, Dr (97257345789, tal_mb@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CI, SVR,HR,BP, noradrenalin administration,renal function (time frame: 6 mo). 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 19 Nov 2008.