Effects of Terlipressin on Renal Perfusion in Patients With Septic Shock

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-06-28

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.

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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.

Conditions

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Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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The terlipressin group

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.

Group Type EXPERIMENTAL

Terlipressin treatment

Intervention Type DRUG

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.

The usual care group

Patients in the usual care group were treated with standard care.

Group Type PLACEBO_COMPARATOR

Usual care

Intervention Type DRUG

Patients in the usual care group were treated with standard care, according to the international guidelines for the management of sepsis and septic shock.

Interventions

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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.

Intervention Type DRUG

Usual care

Patients in the usual care group were treated with standard care, according to the international guidelines for the management of sepsis and septic shock.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No