Effects of Terlipressin on Renal Perfusion in Patients With Septic Shock

Not Applicable

Completed

• Conditions: Septic Shock
• Interventions: Drug: Usual care; Drug: Terlipressin treatment

• Registration Number: NCT04948372
• Lead Sponsor: Southeast University, China

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2020-05-31
• Study Completion: 2020-06-28
• Study First Submitted: 2021-05-26
• Status Verified: 2021-06
• Study First Submitted QC: 2021-06-26
• Last Update Submitted: 2021-06-26
• Study First Posted: 2021-07-01
• Last Update Posted: 2021-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. Adult septic shock patients (age≥18 years old)
2. Norepinephrine dose was more than or equal to 15μg/min

Exclusion Criteria

1. Age older than 85 years
2. Serum creatinine more than 177 μmol/L
3. Acute myocardial ischemia
4. Acute mesenteric artery ischemia
5. Pregnancy
6. Expected death within 24 hours.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The usual care group	Usual care	Patients in the usual care group were treated with standard care.
The terlipressin group	Terlipressin treatment	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.

Primary Outcome Measures

Name	Time	Method
Peak intensity	24 hours after enrollment	Peak intensity is the peak concentration of contrast agent, a kind of renal perfusion parameter monitored by renal contrast-enhanced ultrasound.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nanjing Zhongda Hospital, Southeast University; 🇨🇳 Nanjing, Jiangsu, China