Continuos Terlipressin Infusion in Septic Shock

Study Overview
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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.

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

Conditions
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Septic Shock

Intervention / Treatment
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* Drug: Terlipressin
* Drug: Norepinephrine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: terlipressin<br> | Drug: Terlipressin<br>* continuous infusion of terlipressin (0.66ug/min-2.66ug/min) ,dosage modified acorrding to blood pressure<br>|
| Active Comparator: norepinephrine<br> | Drug: Norepinephrine<br>* continuous infusion with dose 7.5ug/min-30ug/min,modified acorrding to blood pressure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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