Continuos Terlipressin Infusion in Septic Shock

Not Applicable

• Conditions: Septic Shock
• Interventions: Drug: Norepinephrine; Drug: Terlipressin

• Registration Number: NCT01697410
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

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.

Study Timeline

• Study First Submitted: 2012-08-28
• Study First Submitted QC: 2012-09-27
• Study First Posted: 2012-10-02
• Study Start: 2013-01
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-25
• Last Update Posted: 2014-12-30
• Primary Completion: 2016-01
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
norepinephrine	Norepinephrine	-
terlipressin	Terlipressin	-

Primary Outcome Measures

Name	Time	Method
28-day Mortality	28-days	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

Name	Time	Method
days alive and free of vasopressor	during the first 28 days after the start of the infusion	Days of vasopressor were recorded after the start of the infusion in both groups.
SOFA score	7 days	SOFA score was measured on day0-7 after the start of the infusion in both groups
90-day mortality	90 days after the start of the infusion

Trial Locations

Locations (1)

Surgical intensive care unit, 1st affiliated hospital of Sun Yat-sen university; 🇨🇳 Guangzhou, Guangdong, China