Back to resultsEffects of Terlipressin on Renal Perfusion in Patients With Septic Shock
Primary Purpose
Septic Shock
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Terlipressin treatment
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Septic Shock focused on measuring septic shock, terlipressin, renal perfusion, acute kidney injury
Eligibility Criteria
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.
Sites / Locations
- Nanjing Zhongda Hospital, Southeast University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
The terlipressin group
The usual care group
Arm Description
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.
Patients in the usual care group were treated with standard care.
Outcomes
Primary Outcome Measures
Peak intensity
Peak intensity is the peak concentration of contrast agent, a kind of renal perfusion parameter monitored by renal contrast-enhanced ultrasound.
Secondary Outcome Measures
urine output, mL
urine output with 24 hours
The incidence of acute kidney injury
Defined as serum creatinine increase≥50% within seven days or increase≥26.5 μmol/L within 48 hours
Full Information
NCT ID
NCT04948372
First Posted
May 26, 2021
Last Updated
June 26, 2021
Sponsor
Southeast University, China
1. Study Identification
Unique Protocol Identification Number
NCT04948372
Brief Title
Effects of Terlipressin on Renal Perfusion in Patients With Septic Shock
Official Title
Effects of Terlipressin Added to Usual Care vs. Usual Care Alone on Renal Perfusion in Patients With Septic Shock
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
June 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast University, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
septic shock, terlipressin, renal perfusion, acute kidney injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The terlipressin group
Arm Type
Experimental
Arm Description
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.
Arm Title
The usual care group
Arm Type
Placebo Comparator
Arm Description
Patients in the usual care group were treated with standard care.
Intervention Type
Drug
Intervention Name(s)
Terlipressin treatment
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Usual care
Intervention Description
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 Outcome Measure Information:
Title
Peak intensity
Description
Peak intensity is the peak concentration of contrast agent, a kind of renal perfusion parameter monitored by renal contrast-enhanced ultrasound.
Time Frame
24 hours after enrollment
Secondary Outcome Measure Information:
Title
urine output, mL
Description
urine output with 24 hours
Time Frame
24 hours after enrollment
Title
The incidence of acute kidney injury
Description
Defined as serum creatinine increase≥50% within seven days or increase≥26.5 μmol/L within 48 hours
Time Frame
Within 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Nanjing Zhongda Hospital, Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Terlipressin on Renal Perfusion in Patients With Septic Shock
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