Continuos Terlipressin Infusion in Septic Shock

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

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

Study Overview

• Status: Unknown
• Conditions: Septic Shock
• Intervention / Treatment: Drug: Terlipressin; Drug: Norepinephrine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guan Xiangdong, M.D.; Phone Number: 862087755766-8456; Email: carlg@163.net
• Study Contact Backup: Name: Liu Zimeng, M.D.; Phone Number: 862087755766-8454; Email: sumslzm@163.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: norepinephrine	Drug: Norepinephrine; continuous infusion with dose 7.5ug/min-30ug/min,modified acorrding to blood pressure
Experimental: terlipressin	Drug: Terlipressin; continuous infusion of terlipressin (0.66ug/min-2.66ug/min) ,dosage modified acorrding to blood pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SOFA score	SOFA score was measured on day0-7 after the start of the infusion in both groups	7 days
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
90-day mortality		90 days after the start of the infusion

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Collaborators: Guangxi Medical University; China Medical University, China; Xiangya Hospital of Central South University; Beijing 302 Hospital; Chinese PLA General Hospital; West China Hospital; Second Affiliated Hospital, Sun Yat-Sen University; Sixth Affiliated Hospital, Sun Yat-sen University; Wuhan Union Hospital, China; First People's Hospital of Foshan; Health Science Center of Xi'an Jiaotong University; Shanghai Changzheng Hospital; First Affiliated Hospital Bengbu Medical College; Jinling Hospital, China; Guangdong Province, Department of Science and Technology; Anhui Provincial Hospital; ZhuHai Hospital; Hainan People's Hospital
• Investigators: Study Chair: Guan XiangDong, doctor, first affiliated hospital SunYetSen university; Study Director: liu ZiMeng, M.D, first affiliated hospital ,SunYetSen university; Principal Investigator: Si Xiang, M.D., first affiliated hospital ,SunYetSen university; Principal Investigator: Chen Juan, M.D., first affiliated hospital ,SunYetSen university

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: August 28, 2012
• First Submitted That Met QC Criteria: September 27, 2012
• First Posted (Estimate): October 2, 2012

Study Record Updates

• Last Update Posted (Estimate): December 30, 2014
• Last Update Submitted That Met QC Criteria: December 25, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Sympathomimetics; Vasoconstrictor Agents; Norepinephrine; Terlipressin
• Other Study ID Numbers: 2012A080204018;2007015