Effects of Terlipressin on Renal Perfusion in Patients With Septic Shock

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04948372

Enrollment

Registered

2021-07-01

Start date

2019-09-01

Completion date

2020-06-28

Last updated

2021-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Keywords

septic shock, terlipressin, renal perfusion, acute kidney injury

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.

Interventions

DRUGTerlipressin 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.

DRUGUsual 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
urine output, mL	24 hours after enrollment	urine output with 24 hours
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026