New arm cuff technique aims to shield kidneys during septic shock
NCT ID NCT07481097
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new way to guide fluid treatment in patients with septic shock (a severe infection causing low blood pressure). The goal is to see if using a non-invasive arm cuff to measure blood flow pressure can help doctors give the right amount of fluids to prevent acute kidney injury. About 100 adults in the ICU who are on breathing machines will be randomly assigned to either the new method or standard care. The main focus is whether fewer patients develop kidney damage within 7 days.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adult patients (Age 18 years or older) admitted to the Intensive Care Unit. * Primary diagnosis of Septic Shock defined according to the Third International Consensus Definitions for Sepsis (Sepsis-3): Sepsis with persisting hypotension requiring vasopressors to maintain MAP 65 mmHg or greater and having a serum lactate level greater than 2 mmol/L despite adequate volume resuscitation. * Patients must be mechanically ventilated and sedated to ensure baseline hemodynamic stability. * Presence of an invasive arterial catheter and a central venous catheter. Exclusion Criteria: * Known pre-existing chronic kidney disease (CKD Stage 4 or 5) or patients on chronic renal replacement therapy. * Contraindications to arm cuff inflation, including upper limb trauma, -lymphedema, arteriovenous fistula, or peripheral vascular disease. * Severe valvular heart disease, specifically severe tricuspid regurgitation, which invalidates CVP interpretation. * Intra-abdominal hypertension (Intra-abdominal pressure greater than 15 mmHg) which mechanically alters venous return independent of blood volume. * Moribund patients with a predicted mortality within 24 hours.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Assiut University Hospitals
Asyut, Asyut Governorate, 71511, Egypt
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Gut microbes may hold clues to sepsis organ injury
- Scientists hunt for clues to kidney damage in sepsis
- Kidney injury prediction study for sick kids withdrawn before starting
- Can a simple drug help predict kidney trouble in sepsis?
- New drug TIN816 tested for sepsis kidney damage
- Experimental enzyme shot aims to rescue kidneys in sepsis patients