A Multicenter,Prospective,Randomized,Controlled,Double Blind Study in China to Evaluate the Effect of Terlipressin in Patients With Septic Shock
Overview
- Phase
- Not Applicable
- Intervention
- Terlipressin
- Conditions
- Septic Shock
- Sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- 28-day Mortality
- Last Updated
- 11 years ago
Overview
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.
Investigators
Guan XiangDong
director of surgical intensive care unit
First Affiliated Hospital, Sun Yat-Sen University
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;
Arms & Interventions
terlipressin
Intervention: Terlipressin
norepinephrine
Intervention: Norepinephrine
Outcomes
Primary Outcomes
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
Secondary Outcomes
- days alive and free of vasopressor(during the first 28 days after the start of the infusion)
- SOFA score(7 days)
- 90-day mortality(90 days after the start of the infusion)