Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute … (NCT07481097) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
Egypt100 participantsStarted 2026-04-01
Plain-language summary
The goal of this clinical trial is to evaluate the efficacy of a hemodynamic resuscitation protocol guided by the Venous Return Gradient (Pmsf - CVP), measured via the non-invasive arm cuff technique, in reducing the incidence of Acute Kidney Injury (AKI) in patients with septic shock compared to standard care and to assess the precision and reproducibility of the non-invasive arm cuff Pmsf measurement in the septic shock population and to determine the correlation between the systemic Venous Return Gradient and the renal micro-circulatory Resistance Index (RRI).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is listed as 'not yet recruiting' — do you know when it's expected to open, and whether it would still be relevant to my situation by the time enrollment begins?
2The study is comparing two different approaches to fluid resuscitation in septic shock, one of which uses a non-invasive measurement called mean systemic filling pressure — can you explain how that differs from how my fluids would normally be managed, and what that would mean for my day-to-day care in the ICU?
3The trial tracks whether patients develop acute kidney injury within 7 days using something called KDIGO criteria — given my current kidney function and creatinine levels, how much risk do I already have of AKI, and does that affect whether this trial might or might not be a good fit to discuss with you?
4Since this is listed as Phase NA, meaning it may be a feasibility or pilot study rather than a late-stage efficacy trial, what does that mean about how much is already known about whether this monitoring approach is safe and beneficial compared to standard care?
5Are there standard-of-care resuscitation protocols already being used here for septic shock that I should understand first, so I can better compare them to what this trial is testing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To compare the incidence of Acute Kidney Injury (AKI) in septic shock in both groups after 7 days of inclusion in the study. (AKI defined by KDIGO criteria: Creatinine increase ≥ 0.3 mg/dl within 48h OR ≥ 1.5x baseline within 7 days)