Septic ShockNCT01697410
Continuos Terlipressin Infusion in Septic Shock
A study testing Terlipressin and Norepinephrine in people with Septic Shock, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy of terlipressin for treating septic shock. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Terlipressin and Norepinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Jan 2016
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Septic shock was defined by the presence of two or more diagnostic criteria for the systemic inflammatory responsesyndrome, proven or suspected infection, and hypotension (exclusion of hypertention other than sepsis)
Who cannot join
- organ transplantation;
- pregancy or breast-feeding;
- malignancy or other irreversible disease or condition for which has a poor prognosis;
- acute coronary syndrome;
- chronic heart failure(NYHA III or IV)/cardiogenic shock;
- acute mesenteric ischemia;
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- greater than 48 hours had elapsed since the patient met entry criteria;
- estimation of incomplite treament due to financial problem;
- use of terlipressin for blood pressure support before entry;
- Raynaud's phenomenon, systemic sclerosis or vasospastic diathesis;
- registration of other clinical trial which will affect the outcome of the current study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Surgical intensive care unit, 1st affiliated hospital of Sun Yat-sen university
Guangzhou, Guangdong, 510000
Guan Xiangdong, M.D., 862087555766-8456, carlg@163.net
Guan Xiangdon, M.D
About this study
Official title: A Multicenter,Prospective,Randomized,Controlled,Double Blind Study in China to Evaluate the Effect of Terlipressin in Patients With Septic Shock
The purpose of this study is to evaluate the efficacy of terlipressin for treating septic shock.
Read the detailed description
Septic shock is the most common cause of death in intensive care units and has a mortality rate of 40 to 60%.Vasopressin is commonly used as an adjunct to catecholamines to support blood pressure in refractory septic shock.Recently small sample clinical study suggest that Terlipressin,a vasopressin analogues, was effective in reversing sepsis-induced arterial hypotension and in reducing norepinephrine requirements.But its effect on mortality is unknown.Invesgators hypothesized that Terlipressin as compared with norepinephrine would decrease mortality among patients with septic shock.
- Conditions
- 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
continuous infusion of terlipressin (0.66ug/min-2.66ug/min) ,dosage modified acorrding to blood pressure
NorepinephrineDrug
continuous infusion with dose 7.5ug/min-30ug/min,modified acorrding to blood pressure
| Study group | Role | What they receive |
|---|---|---|
| terlipressin | Experimental | Not described Receives: Drug: Terlipressin |
| norepinephrine | Active comparator | Not described Receives: Drug: Norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day Mortality
The prospectively defined primary end point was death from any cause and was assessed 28 days after the start of the infusion
Measured: 28-days
Secondary outcomes (3)
SOFA score
SOFA score was measured on day0-7 after the start of the infusion in both groups
Measured: 7 days
days alive and free of vasopressor
Days of vasopressor were recorded after the start of the infusion in both groups.
Measured: during the first 28 days after the start of the infusion
90-day mortality
Measured: 90 days after the start of the infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startJan 2013
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Province, Department of Science and Technology, Second Affiliated Hospital, Sun Yat-Sen University, Sixth Affiliated Hospital, Sun Yat-sen University, Chinese PLA General Hospital, Beijing 302 Hospital, Shanghai Changzheng Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Xiangya Hospital of Central South University, Anhui Provincial Hospital, The First Affiliated Hospital of Bengbu Medical University, Guangxi Medical University, Jinling Hospital, China, West China Hospital, Hainan People's Hospital, Xi'an Jiaotong University, China Medical University, China, First People's Hospital of Foshan, ZhuHai Hospital
- Responsible party
- Principal investigator, Guan XiangDong, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Guan XiangDong, doctor, Study chair, first affiliated hospital SunYetSen universityliu ZiMeng, M.D, Study director, first affiliated hospital ,SunYetSen universitySi Xiang, M.D., Principal investigator, first affiliated hospital ,SunYetSen universityChen Juan, M.D., Principal investigator, first affiliated hospital ,SunYetSen university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697410
- Sponsor's protocol ID
- 2012A080204018;2007015
- Status last verified
- Dec 2014
- First submitted
- 28 Aug 2012
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liu ZM, Chen J, Kou Q, Lin Q, Huang X, Tang Z, Kang Y, Li K, Zhou L, Song Q, Sun T, Zhao L, Wang X, He X, Wang C, Wu B, Lin J, Yuan S, Gu Q, Qian K, Shi X, Feng Y, Lin A, He X; Study Group of investigators; Guan XD. Terlipressin versus norepinephrine as infusion in patients with septic shock: a multicentre, randomised, double-blinded trial. Intensive Care Med. 2018 Nov;44(11):1816-1825. doi: 10.1007/s00134-018-5267-9. Epub 2018 Jul 3.
PubMed 29971593
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
- A Multicenter,Prospective,Randomized,Controlled,Double Blind Study in China to Evaluate the Effect of Terlipressin in Patients With Septic Shock
- ClinicalTrials.gov ID
- NCT01697410
- Acronym / sponsor ID
- 2012A080204018;2007015
- Conditions
- Septic Shock
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Guangdong Province, Department of Science and Technology, Second Affiliated Hospital, Sun Yat-Sen University, Sixth Affiliated Hospital, Sun Yat-sen University, Chinese PLA General Hospital, Beijing 302 Hospital, Shanghai Changzheng Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Xiangya Hospital of Central South University, Anhui Provincial Hospital, The First Affiliated Hospital of Bengbu Medical University, Guangxi Medical University, Jinling Hospital, China, West China Hospital, Hainan People's Hospital, Xi'an Jiaotong University, China Medical University, China, First People's Hospital of Foshan, ZhuHai Hospital
- Study start
- Jan 2013
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 2 Oct 2012 (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.
The purpose of this study is to evaluate the efficacy of terlipressin for treating septic shock.
Detailed description
Septic shock is the most common cause of death in intensive care units and has a mortality rate of 40 to 60%.Vasopressin is commonly used as an adjunct to catecholamines to support blood pressure in refractory septic shock.Recently small sample clinical study suggest that Terlipressin,a vasopressin analogues, was effective in reversing sepsis-induced arterial hypotension and in reducing norepinephrine requirements.But its effect on mortality is unknown.Invesgators hypothesized that Terlipressin as compared with norepinephrine would decrease mortality among patients with septic shock.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| terlipressin | Experimental | Drug: Terlipressin |
| norepinephrine | Active comparator | Drug: Norepinephrine |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Septic shock was defined by the presence of two or more diagnostic criteria for the systemic inflammatory responsesyndrome, proven or suspected infection, and hypotension (exclusion of hypertention other than sepsis)
Key exclusion criteria (11 listed)
- organ transplantation;
- pregancy or breast-feeding;
- malignancy or other irreversible disease or condition for which has a poor prognosis;
- acute coronary syndrome;
- chronic heart failure(NYHA III or IV)/cardiogenic shock;
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 |
|---|---|---|
| Terlipressincontinuous infusion of terlipressin (0.66ug/min-2.66ug/min) ,dosage modified acorrding to blood pressure | Drug | terlipressin |
| Norepinephrinecontinuous infusion with dose 7.5ug/min-30ug/min,modified acorrding to blood pressure | Drug | norepinephrine |
Primary outcome
28-day Mortality
Time frame: 28-days
The prospectively defined primary end point was death from any cause and was assessed 28 days after the start of the infusion
3 secondary outcomes
SOFA score
Time frame: 7 days
days alive and free of vasopressor
Time frame: during the first 28 days after the start of the infusion
90-day mortality
Time frame: 90 days after the start of the infusion
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.
- Derived from this study: PubMed 29971593Liu ZM, Chen J, Kou Q, Lin Q, Huang X, Tang Z, Kang Y, Li K, Zhou L, Song Q, Sun T, Zhao L, Wang X, He X, Wang C, Wu B, Lin J, Yuan S, Gu Q, Qian K, Shi X, Feng Y, Lin A, He X; Study Group of investigators; Guan XD. Terlipressin versus norepinephrine as infusion in patients with septic shock: a multicentre, randomised, double-blinded trial. Intensive Care Med. 2018 Nov;44(11):1816-1825. doi: 10.1007/s00134-018-5267-9. Epub 2018 Jul 3.
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Sepsis
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.
Guan XiangDong, doctor study chair
first affiliated hospital SunYetSen university
liu ZiMeng, M.D study director
first affiliated hospital ,SunYetSen university
Si Xiang, M.D. principal investigator
first affiliated hospital ,SunYetSen university
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 Septic Shock, run by First Affiliated Hospital, Sun Yat-Sen University 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 11 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 Guan Xiangdong, M.D. (862087755766-8456, carlg@163.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day Mortality (time frame: 28-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01697410, which also lists 1 linked publication.
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.