Continuos Terlipressin Infusion in Septic Shock

NCT ID: NCT01697410

Last Updated: 2014-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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terlipressin

Group Type EXPERIMENTAL

Terlipressin

Intervention Type DRUG

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

norepinephrine

Group Type ACTIVE_COMPARATOR

Norepinephrine

Intervention Type DRUG

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

Interventions

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Terlipressin

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

Intervention Type DRUG

Norepinephrine

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong Province, Department of Science and Technology

OTHER_GOV

Sponsor Role collaborator

Second Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role collaborator

Beijing 302 Hospital

OTHER

Sponsor Role collaborator

Shanghai Changzheng Hospital

OTHER

Sponsor Role collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

The First Affiliated Hospital of Bengbu Medical University

OTHER

Sponsor Role collaborator

Guangxi Medical University

OTHER

Sponsor Role collaborator

Jinling Hospital, China

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role collaborator

Hainan People's Hospital

OTHER

Sponsor Role collaborator

Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

China Medical University, China

OTHER

Sponsor Role collaborator

First People's Hospital of Foshan

OTHER

Sponsor Role collaborator

ZhuHai Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Guan XiangDong

director of surgical intensive care unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guan XiangDong, doctor

Role: STUDY_CHAIR

first affiliated hospital SunYetSen university

liu ZiMeng, M.D

Role: STUDY_DIRECTOR

first affiliated hospital ,SunYetSen university

Si Xiang, M.D.

Role: PRINCIPAL_INVESTIGATOR

first affiliated hospital ,SunYetSen university

Chen Juan, M.D.

Role: PRINCIPAL_INVESTIGATOR

first affiliated hospital ,SunYetSen university

Locations

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

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guan Xiangdong, M.D.

Role: CONTACT

Phone: 862087755766-8456

Email: [email protected]

Liu Zimeng, M.D.

Role: CONTACT

Phone: 862087755766-8454

Email: [email protected]

Facility Contacts

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Guan Xiangdong, M.D.

Role: primary

References

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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.

Reference Type DERIVED
PMID: 29971593 (View on PubMed)

Other Identifiers

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2012A080204018;2007015

Identifier Type: -

Identifier Source: org_study_id