Continuos Terlipressin Infusion in Septic Shock

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2012 by First Affiliated Hospital, Sun Yat-Sen University
Sponsor:
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
Xi’an Jiaotong University College of Medicine
China Medical University, China
First People's Hospital of Foshan
Zhuhai People's Hospital
Information provided by (Responsible Party):
Guan XiangDong, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01697410
First received: August 28, 2012
Last updated: September 27, 2012
Last verified: August 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 First Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • 28-day Mortality [ Time Frame: 28-days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: July 2014 (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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Not yet 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
Xi’an Jiaotong University College of Medicine
China Medical University, China
First People's Hospital of Foshan
Zhuhai 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
  More Information

No publications provided

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;200705
Study First Received: August 28, 2012
Last Updated: September 27, 2012
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 19, 2014