Septic ShockNCT04948372
Effects of Terlipressin on Renal Perfusion in Patients With Septic Shock
A study testing Terlipressin treatment in people with Septic Shock, run by Southeast University, China at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- Terlipressin treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 28 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult septic shock patients (age≥18 years old)
- Norepinephrine dose was more than or equal to 15μg/min
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210000
About this study
Official title: Effects of Terlipressin Added to Usual Care vs. Usual Care Alone 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.
Read the 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.
- Conditions
- Septic Shock
- Being tested
- Terlipressin treatment, Usual care
- Keywords
- septic shock, terlipressin, renal perfusion, acute kidney injury
- Medical subject headings
- Shock, Septic, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terlipressin treatmentDrug
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 careDrug
Patients in the usual care group were treated with standard care, according to the international guidelines for the management of sepsis and septic shock.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Terlipressin treatment |
| The usual care group | Placebo comparator | Patients in the usual care group were treated with standard care. Receives: Drug: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak intensity
Peak intensity is the peak concentration of contrast agent, a kind of renal perfusion parameter monitored by renal contrast-enhanced ultrasound.
Measured: 24 hours after enrollment
Secondary outcomes (2)
urine output, mL
urine output with 24 hours
Measured: 24 hours after enrollment
The incidence of acute kidney injury
Defined as serum creatinine increase≥50% within seven days or increase≥26.5 μmol/L within 48 hours
Measured: Within 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start1 Sep 2019
- Primary completion31 May 2020
- Study completion28 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingyuan,Xu, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948372
- Sponsor's protocol ID
- 2019ZDSYLL196-P01
- Status last verified
- Jun 2021
- First submitted
- 26 May 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Terlipressin Added to Usual Care vs. Usual Care Alone on Renal Perfusion in Patients With Septic Shock
- ClinicalTrials.gov ID
- NCT04948372
- Acronym / sponsor ID
- 2019ZDSYLL196-P01
- Conditions
- Septic Shock
- Keywords
- septic shock, terlipressin, renal perfusion, acute kidney injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 28 Jun 2020 (actual)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The terlipressin group | Experimental | Drug: Terlipressin treatmentPatients 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 usual care group | Placebo comparator | Drug: Usual carePatients in the usual care group were treated with standard care. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult septic shock patients (age≥18 years old)
- Norepinephrine dose was more than or equal to 15μg/min
Key exclusion criteria (6 listed)
- Age older than 85 years
- Serum creatinine more than 177 μmol/L
- Acute myocardial ischemia
- Acute mesenteric artery ischemia
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Terlipressin treatmentPatients 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 | The terlipressin group |
| Usual carePatients in the usual care group were treated with standard care, according to the international guidelines for the management of sepsis and septic shock. | Drug | The usual care group |
Primary outcome
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.
2 secondary outcomes
urine output, mL
Time frame: 24 hours after enrollment
The incidence of acute kidney injury
Time frame: Within 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Septic Shock
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
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Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Terlipressin treatment in people with Septic Shock, run by Southeast University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak intensity (time frame: 24 hours after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.