Continuos Terlipressin Infusion in Septic Shock

NCT01697410 | Unknown DMC

• 1 other identifier: 2012A080204018;2007015
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• SOFA score

  7 days

• days alive and free of vasopressor

  during the first 28 days after the start of the infusion

• 90-day mortality

  90 days after the start of the infusion

Study Arms (2)

terlipressin

EXPERIMENTAL

Drug: Terlipressin

norepinephrine

ACTIVE COMPARATOR

Drug: Norepinephrine

Interventions

Terlipressin DRUG

continuous infusion of terlipressin (0.66ug/min-2.66ug/min) ,dosage modified acorrding to blood pressure

terlipressin

Norepinephrine DRUG

continuous infusion with dose 7.5ug/min-30ug/min,modified acorrding to blood pressure

norepinephrine

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Surgical intensive care unit, 1st affiliated hospital of Sun Yat-sen university

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 29971593 DERIVED

MeSH Terms

Conditions

Shock, Septic

Interventions

Terlipressin; Norepinephrine

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Guan XiangDong, doctor

  first affiliated hospital SunYetSen university

  STUDY CHAIR

• liu ZiMeng, M.D

  first affiliated hospital ,SunYetSen university

  STUDY DIRECTOR

• Si Xiang, M.D.

  first affiliated hospital ,SunYetSen university

  PRINCIPAL INVESTIGATOR

• Chen Juan, M.D.

  first affiliated hospital ,SunYetSen university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guan Xiangdong, M.D.

CONTACT

862087755766-8456; carlg@163.net

Liu Zimeng, M.D.

CONTACT

862087755766-8454; sumslzm@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of surgical intensive care unit

Study Record Dates

• First Submitted: August 28, 2012
• First Posted: October 2, 2012
• Study Start: January 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: December 30, 2014

Record last verified: 2014-12

Locations

CN (1)