TerlipressinNCT02306239
The Effect of Terlipressin on Intesitnal Function in Septic Shock Patients
A study testing Terlipressin and Norepinephrine in people with Terlipressin and Septic Shock, run by Liu ZiMeng at 1 site in China.
Trial summary
Terlipressin becomes a vasopressin for septic shock. But some studies found it may lead to severe intesitnal complications such as intestinal ischemia. The investigators study was designed to find the effect of terlipressin on intestinal function in septic shock patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Terlipressin, Septic Shock
- What is being tested?
- Terlipressin and Norepinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Aug 2015
- Phase
- Interventional
- 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
- septic shock
Who cannot join
- shock due to other reasons
- diagnosited intesitinal ischemia
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Sumyetsan University
Guangzhou, Guangdong, 510080
liu zimeng, doctor, 020 ext. 87755766, sumslzm@163.com
zhang xuyu, doctor, 020 ext. 87755766, sumsxyz@163.com
About this study
Official title: the Surgical Intensive Care Unit
Terlipressin becomes a vasopressin for septic shock. But some studies found it may lead to severe intesitnal complications such as intestinal ischemia. The investigators study was designed to find the effect of terlipressin on intestinal function in septic shock patients.
- Conditions
- Terlipressin, Septic Shock
- Being tested
- Terlipressin, Norepinephrine
- 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
NorepinephrineDrug
| Study group | Role | What they receive |
|---|---|---|
| norepinephrine | Active comparator | patients received norepinephrine Receives: Drug: Norepinephrine |
| terlipressin | Experimental | patients received terlipressin Receives: Drug: Terlipressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
intestinal function assessed by abdominal distension, intestinal bleeding, peritonitis, plasma DAO level, enteral nutrition
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TerlipressinStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liu ZiMeng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liu ZiMeng, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- liu zimeng, master, Principal investigator, the first affiliated hospital of SUMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306239
- Sponsor's protocol ID
- 2012A080204018
- Status last verified
- Dec 2014
- First submitted
- 1 Dec 2014
- Last updated
- 30 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Surgical Intensive Care Unit
- ClinicalTrials.gov ID
- NCT02306239
- Acronym / sponsor ID
- 2012A080204018
- Conditions
- Terlipressin, Septic Shock
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Liu ZiMengUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Aug 2015 (estimated)
- First posted
- 3 Dec 2014 (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 becomes a vasopressin for septic shock. But some studies found it may lead to severe intesitnal complications such as intestinal ischemia. The investigators study was designed to find the effect of terlipressin on intestinal function in septic shock patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| norepinephrine | Active comparator | Drug: Norepinephrinepatients received norepinephrine |
| terlipressin | Experimental | Drug: Terlipressinpatients received terlipressin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- septic shock
Key exclusion criteria (2 listed)
- shock due to other reasons
- diagnosited intesitinal ischemia
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 |
|---|---|---|
| Terlipressin | Drug | terlipressin |
| Norepinephrine | Drug | norepinephrine |
Primary outcome
intestinal function assessed by abdominal distension, intestinal bleeding, peritonitis, plasma DAO level, enteral nutrition
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2014.
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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.
liu zimeng, master principal investigator
the first affiliated hospital of SUMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Terlipressin and Norepinephrine in people with Terlipressin and Septic Shock, run by Liu ZiMeng at 1 site in China.
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 2 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 30 Dec 2014. 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 China. 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.
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 liu zimeng, master (020-87755766, sumslzm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intestinal function assessed by abdominal distension, intestinal bleeding, peritonitis, plasma DAO level, enteral nutrition (time frame: 7 days). 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 30 Dec 2014.