Septic Shock
Conditions
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.
Interventions
DRUGTerlipressin
continuous infusion of terlipressin (0.66ug/min-2.66ug/min) ,dosage modified acorrding to blood pressure
DRUGNorepinephrine
continuous infusion with dose 7.5ug/min-30ug/min,modified acorrding to blood pressure
Sponsors
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
First Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28-day Mortality | 28-days | The prospectively defined primary end point was death from any cause and was assessed 28 days after the start of the infusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SOFA score | 7 days | SOFA score was measured on day0-7 after the start of the infusion in both groups |
| days alive and free of vasopressor | during the first 28 days after the start of the infusion | Days of vasopressor were recorded after the start of the infusion in both groups. |
| 90-day mortality | 90 days after the start of the infusion | — |
Countries
China
Contacts
Primary ContactGuan Xiangdong, M.D.
Backup ContactLiu Zimeng, M.D.
Outcome results
None listed