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Continuos Terlipressin Infusion in Septic Shock

Primary Purpose

Septic Shock

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Terlipressin

Norepinephrine

About this trial

This is an interventional treatment trial for Septic Shock

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

terlipressin

norepinephrine

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

SOFA score

SOFA score was measured on day0-7 after the start of the infusion in both groups

days alive and free of vasopressor

Days of vasopressor were recorded after the start of the infusion in both groups.

90-day mortality

Full Information

NCT ID

NCT01697410

First Posted

August 28, 2012

Last Updated

December 25, 2014

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

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

1. Study Identification

Unique Protocol Identification Number

NCT01697410

Brief Title

Continuos Terlipressin Infusion in Septic Shock

Official Title

A Multicenter,Prospective,Randomized,Controlled,Double Blind Study in China to Evaluate the Effect of Terlipressin in Patients With Septic Shock

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Unknown status

Study Start Date

January 2013 (undefined)

Primary Completion Date

January 2016 (Anticipated)

Study Completion Date

January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Septic Shock

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

terlipressin

Arm Type

Experimental

Arm Title

norepinephrine

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Terlipressin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Norepinephrine

Intervention Description

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

Primary Outcome Measure Information:

Title

28-day Mortality

Description

The prospectively defined primary end point was death from any cause and was assessed 28 days after the start of the infusion

Time Frame

28-days

Secondary Outcome Measure Information:

Title

SOFA score

Description

SOFA score was measured on day0-7 after the start of the infusion in both groups

Time Frame

7 days

Title

days alive and free of vasopressor

Description

Days of vasopressor were recorded after the start of the infusion in both groups.

Time Frame

during the first 28 days after the start of the infusion

Title

90-day mortality

Time Frame

90 days after the start of the infusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Guan Xiangdong, M.D.

Phone

862087755766-8456

carlg@163.net

First Name & Middle Initial & Last Name or Official Title & Degree

Liu Zimeng, M.D.

Phone

862087755766-8454

sumslzm@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guan XiangDong, doctor

Organizational Affiliation

first affiliated hospital SunYetSen university

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

liu ZiMeng, M.D

Organizational Affiliation

first affiliated hospital ,SunYetSen university

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Si Xiang, M.D.

Organizational Affiliation

first affiliated hospital ,SunYetSen university

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Chen Juan, M.D.

Organizational Affiliation

first affiliated hospital ,SunYetSen university

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guan Xiangdong, M.D.

Phone

862087555766-8456

carlg@163.net

First Name & Middle Initial & Last Name & Degree

Guan Xiangdon, M.D

12. IPD Sharing Statement

Citations:

PubMed Identifier

29971593

Citation

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.

Results Reference

derived

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Continuos Terlipressin Infusion in Septic Shock

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