Continuos Terlipressin Infusion in Septic Shock

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01697410
• Other study ID #: 2012A080204018;2007015
• Status: Recruiting
• Phase: N/A
• First received: August 28, 2012
• Last updated: December 25, 2014
• Start date: January 2013
• Est. completion date: January 2016

Study information

• Verified date: December 2014
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Guan Xiangdong, M.D.
• Phone: 862087755766-8456
• Email: carlg[@]163.net
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Terlipressin
continuous infusion of terlipressin (0.66ug/min-2.66ug/min) ,dosage modified acorrding to blood pressure
• Norepinephrine
continuous infusion with dose 7.5ug/min-30ug/min,modified acorrding to blood pressure

Locations

Country	Name	City	State
China	Surgical intensive care unit, 1st affiliated hospital of Sun Yat-sen university	Guangzhou	Guangdong

Sponsors (19)

Lead Sponsor

Collaborator

First Affiliated Hospital, Sun Yat-Sen University

Anhui Provincial Hospital, Beijing 302 Hospital, China Medical University, China, Chinese PLA General Hospital, First Affiliated Hospital Bengbu Medical College, First People's Hospital of Foshan, Guangdong Province, Department of Science and Technology, Guangxi Medical University, Hainan People's Hospital, Jinling Hospital, China, Second Affiliated Hospital, Sun Yat-Sen University, Shanghai Changzheng Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, West China Hospital, Wuhan Union Hospital, China, Xi’an Jiaotong University College of Medicine, Xiangya Hospital of Central South University, ZhuHai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	28-days	No
Secondary	SOFA score	SOFA score was measured on day0-7 after the start of the infusion in both groups	7 days	No
Secondary	days alive and free of vasopressor	Days of vasopressor were recorded after the start of the infusion in both groups.	during the first 28 days after the start of the infusion	No
Secondary	90-day mortality		90 days after the start of the infusion	No