We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Continuos Terlipressin Infusion in Septic Shock

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by Guan XiangDong, First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01697410
First Posted: October 2, 2012
Last Update Posted: December 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
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
Wuhan Union Hospital, China
Xiangya Hospital of Central South University
Anhui Provincial Hospital
First Affiliated Hospital Bengbu Medical College
Guangxi Medical University
Jinling Hospital, China
West China Hospital
Hainan People's Hospital
Health Science Center of Xi’an Jiaotong University
China Medical University, China
First People's Hospital of Foshan
ZhuHai Hospital
Information provided by (Responsible Party):
Guan XiangDong, First Affiliated Hospital, Sun Yat-Sen University
  Purpose
The purpose of this study is to evaluate the efficacy of terlipressin for treating septic shock.

Condition Intervention
Septic Shock Drug: Terlipressin Drug: Norepinephrine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter,Prospective,Randomized,Controlled,Double Blind Study in China to Evaluate the Effect of Terlipressin in Patients With Septic Shock

Resource links provided by NLM:


Further study details as provided by Guan XiangDong, First Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • SOFA score [ Time Frame: 7 days ]
    SOFA score was measured on day0-7 after the start of the infusion in both groups

  • days alive and free of vasopressor [ Time Frame: 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 [ Time Frame: 90 days after the start of the infusion ]

Estimated Enrollment: 1000
Study Start Date: January 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: terlipressin Drug: Terlipressin
continuous infusion of terlipressin (0.66ug/min-2.66ug/min) ,dosage modified acorrding to blood pressure
Active Comparator: norepinephrine Drug: Norepinephrine
continuous infusion with dose 7.5ug/min-30ug/min,modified acorrding to blood pressure

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01697410


Contacts
Contact: Guan Xiangdong, M.D. 862087755766-8456 carlg@163.net
Contact: Liu Zimeng, M.D. 862087755766-8454 sumslzm@163.com

Locations
China, Guangdong
Surgical intensive care unit, 1st affiliated hospital of Sun Yat-sen university Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Guan Xiangdong, M.D.    862087555766-8456    carlg@163.net   
Principal Investigator: Guan Xiangdon, M.D         
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
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
Wuhan Union Hospital, China
Xiangya Hospital of Central South University
Anhui Provincial Hospital
First Affiliated Hospital Bengbu Medical College
Guangxi Medical University
Jinling Hospital, China
West China Hospital
Hainan People's Hospital
Health Science Center of Xi’an Jiaotong University
China Medical University, China
First People's Hospital of Foshan
ZhuHai 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
  More Information

Responsible Party: Guan XiangDong, director of surgical intensive care unit, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01697410     History of Changes
Other Study ID Numbers: 2012A080204018;2007015
First Submitted: August 28, 2012
First Posted: October 2, 2012
Last Update Posted: December 30, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Norepinephrine
Terlipressin
Lypressin
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Antihypertensive Agents
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents