Effects of Terlipressin on Renal Perfusion in Patients With Septic Shock

Study Overview
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Brief Summary
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This open-label, randomized controlled trial aimed to investigate the effect of a fixed dose of terlipressin added to usual care vs. usual care alone on renal perfusion in patients with septic shock.

Detailed Description
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Terlipressin is a synthetic vasopressin analog with great affinity to the V1 receptor (vasoconstrictive effect), and could selectively contract efferent arterioles, increase glomerular filtration pressure and renal perfusion. The investigators conducted this open-label, randomized controlled trial to observe the effects of a fixed dose of terlipressin added to usual care vs. usual care alone on renal perfusion in patients with septic shock. Renal perfusion was monitored by renal contrast-enhanced ultrasound. The primary outcome was peak intensity (renal perfusion parameter) at 24 hours after enrollment.

Official Title
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Effects of Terlipressin Added to Usual Care vs. Usual Care Alone on Renal Perfusion in Patients With Septic Shock

Conditions
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Septic Shock

Intervention / Treatment
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* Drug: Terlipressin treatment
* Drug: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult septic shock patients (age≥18 years old) Norepinephrine dose was more than or equal to 15μg/min Exclusion Criteria: Age older than 85 years Serum creatinine more than 177 μmol/L Acute myocardial ischemia Acute mesenteric artery ischemia Pregnancy Expected death within 24 hours.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The terlipressin group<br>Patients in the terlipressin group received a fixed dose of terlipressin added to usual care. Terlipressin was intravenously pumped at a fixed dose of 1.3μg/kg/hour for 24 hours. | Drug: Terlipressin treatment<br>* Patients in the terlipressin group received a fixed dose of terlipressin added to usual care. Terlipressin was intravenously pumped at a fixed dose of 1.3μg/kg/hour for 24 hours.<br>|
| Placebo Comparator: The usual care group<br>Patients in the usual care group were treated with standard care. | Drug: Usual care<br>* Patients in the usual care group were treated with standard care, according to the international guidelines for the management of sepsis and septic shock.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak intensity | Peak intensity is the peak concentration of contrast agent, a kind of renal perfusion parameter monitored by renal contrast-enhanced ultrasound. | 24 hours after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urine output, mL | urine output with 24 hours | 24 hours after enrollment | 
| The incidence of acute kidney injury | Defined as serum creatinine increase≥50% within seven days or increase≥26.5 μmol/L within 48 hours | Within 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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septic shock, terlipressin, renal perfusion, acute kidney injury