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Continuos Terlipressin Infusion in Septic Shock

Information source: First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Septic Shock

Intervention: Terlipressin (Drug); Norepinephrine (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: First Affiliated Hospital, Sun Yat-Sen University

Official(s) and/or principal investigator(s):
Guan XiangDong, doctor, Study Chair, Affiliation: first affiliated hospital SunYetSen university
liu ZiMeng, M.D, Study Director, Affiliation: first affiliated hospital ,SunYetSen university
Si Xiang, M.D., Principal Investigator, Affiliation: first affiliated hospital ,SunYetSen university
Chen Juan, M.D., Principal Investigator, Affiliation: first affiliated hospital ,SunYetSen university

Overall contact:
Guan Xiangdong, M.D., Phone: 862087755766-8456, Email: carlg@163.net

Summary

The purpose of this study is to evaluate the efficacy of terlipressin for treating septic shock.

Clinical Details

Official title: A Multicenter,Prospective,Randomized,Controlled,Double Blind Study in China to Evaluate the Effect of Terlipressin in Patients With Septic Shock

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 28-day Mortality

Secondary outcome:

SOFA score

days alive and free of vasopressor

90-day mortality

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

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Guan Xiangdong, M.D., Phone: 862087755766-8456, Email: carlg@163.net

Surgical intensive care unit, 1st affiliated hospital of Sun Yat-sen university, Guangzhou, Guangdong 510000, China; Recruiting
Guan Xiangdong, M.D., Phone: 862087555766-8456, Email: carlg@163.net
Guan Xiangdon, M.D, Principal Investigator
Additional Information

Starting date: January 2013
Last updated: December 25, 2014

Page last updated: August 23, 2015

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