Clinical trial NCT01697410: Continuos Terlipressin Infusion in Septic Shock
Official title: A Multicenter,Prospective,Randomized,Controlled,Double Blind Study in China to Evaluate the Effect of Terlipressin in Patients With Septic Shock
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Septic Shock
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Guangdong Province, Department of Science and Technology
name: Second Affiliated Hospital, Sun Yat-Sen University
name: Sixth Affiliated Hospital, Sun Yat-sen University
name: Chinese PLA General Hospital
name: Beijing 302 Hospital
name: Shanghai Changzheng Hospital
name: Wuhan Union Hospital, China
name: Xiangya Hospital of Central South University
name: Anhui Provincial Hospital
name: The First Affiliated Hospital of Bengbu Medical University
name: Guangxi Medical University
name: Jinling Hospital, China
name: West China Hospital
name: Hainan People's Hospital
name: Xi'an Jiaotong University
name: China Medical University, China
name: First People's Hospital of Foshan
name: ZhuHai Hospital
First posted: 2012-10-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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;
* 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

Primary outcomes:
measure: 28-day Mortality
timeFrame: 28-days
Secondary outcomes:
measure: SOFA score
timeFrame: 7 days
measure: days alive and free of vasopressor
timeFrame: during the first 28 days after the start of the infusion
measure: 90-day mortality
timeFrame: 90 days after the start of the infusion
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Surgical intensive care unit, 1st affiliated hospital of Sun Yat-sen university
state: Guangdong
Study officials:
affiliation: first affiliated hospital SunYetSen university
name: Guan XiangDong, doctor
role: STUDY_CHAIR
affiliation: first affiliated hospital ,SunYetSen university
name: liu ZiMeng, M.D
role: STUDY_DIRECTOR
affiliation: first affiliated hospital ,SunYetSen university
name: Si Xiang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: first affiliated hospital ,SunYetSen university
name: Chen Juan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.