Continuos Terlipressin Infusion in Septic Shock

This study is not yet open for participant recruitment.
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

August 28, 2012
September 27, 2012
January 2013
July 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01697410 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Septic Shock
  • Drug: Terlipressin
    continuous infusion of terlipressin (0.66ug/min-2.66ug/min) ,dosage modified acorrding to blood pressure
  • Drug: Norepinephrine
    continuous infusion with dose 7.5ug/min-30ug/min,modified acorrding to blood pressure
  • Experimental: terlipressin
    Intervention: Drug: Terlipressin
  • Active Comparator: norepinephrine
    Intervention: Drug: Norepinephrine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
1000
January 2015
July 2014   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact: Guan Xiangdong, M.D. 862087755766-8456 carlg@163.net
Contact: Liu Zimeng, M.D. 862087755766-8454 sumslzm@163.com
China
 
NCT01697410
2012A080204018;200705
Yes
Guan XiangDong, First Affiliated Hospital, Sun Yat-Sen University
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
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
First Affiliated Hospital, Sun Yat-Sen University
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP