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.
Effects of Terlipressin on Renal Perfusion in Patients With Septic Shock
Status
Completed
Phase
Not applicable
Enrollment
22
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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
Treatment arms and agents.
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.
Timeline
From registration to results.
First posted
Jul 1, 2021
Study start
Sep 1, 2019
Primary completion
May 31, 2020
Study completion
Jun 28, 2020
Results posted
Not reported
Registry updated
Jul 1, 2021
Outcomes
What the study measures.
Primary outcomes
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
urine output, mL
Time frame · 24 hours after enrollment
urine output with 24 hours
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
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 85 Years
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
1 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
Nanjing Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Put the record in context.
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