Effects of Terlipressin on Renal Perfusion in Patients With Septic Shock

NCT04948372 | Completed

• 1 other identifier: 2019ZDSYLL196-P01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Keywords

septic shock; terlipressin; renal perfusion; acute kidney injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• urine output, mL

  24 hours after enrollment

• The incidence of acute kidney injury

  Within 28 days

Study Arms (2)

The terlipressin group

EXPERIMENTAL

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

The usual care group

PLACEBO COMPARATOR

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

Drug: Usual care

Interventions

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.

The terlipressin group

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.

The usual care group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Nanjing Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Shock, Septic; Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: July 1, 2021
• Study Start: September 1, 2019
• Primary Completion: May 31, 2020
• Study Completion: June 28, 2020
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)