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NCT Number: NCT04948372

Effects of Terlipressin on Renal Perfusion in Patients With Septic Shock

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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Key information

Conditions

Septic Shock Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome Urogenital Diseases Urologic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Terlipressin treatment

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.

Usual Care

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.

Primary outcomes

  1. Peak intensity

    Time frame: 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 outcomes

  1. urine output, mL

    Time frame: 24 hours after enrollment

    urine output with 24 hours

  2. The incidence of acute kidney injury

    Time frame: Within 28 days

    Defined as serum creatinine increase≥50% within seven days or increase≥26.5 μmol/L within 48 hours

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 1, 2021
Registry last updated
Jul 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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