Effects of Terlipressin on Renal Perfusion in Patients With Septic Shock

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04948372
• Other study ID #: 2019ZDSYLL196-P01
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: June 28, 2020

Study information

• Verified date: June 2021
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 28, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
China	Nanjing Zhongda Hospital, Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	urine output, mL	urine output with 24 hours	24 hours after enrollment
Secondary	The incidence of acute kidney injury	Defined as serum creatinine increase=50% within seven days or increase=26.5 µmol/L within 48 hours	Within 28 days