Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Starting soon Not applicable

Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock

NCT07481097 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2026-04-01
Last updated
2026-03-18

Condition(s) studied

Acute Kidney Injury Due to Sepsis

Investigational drug(s) / intervention(s)

Hemodynamic measurements during reduction in Norepinephrine and fluid boli.

Hemodynamic measurements during reduction in Norepinephrine and fluid boli.: State 1: Low Gradient and Low Pmsf AND RRI ≤ 0.70: Absolute Hypovolemia. Administer fluid bolus (250-500 ml crystalloid) to recruit stressed volume. State 2: Low Gradient and High Pmsf AND RRI ≥ 0.70: Vasoplegia with relative hypovolemia. Initiate or increase Norepinephrine. State 3: Adequate Gradient but High RRI ≥0.70: Renal Congestion. Discontinue fluids immediately Consider administration of diuretics

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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) — 7 days
    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)

Trial sites (1)

FacilityCityRegionStatus
Assiut University Hospitals Asyut Asyut Governorate
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07481097 on ClinicalTrials.gov ↗ ← All trials in Egypt