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Not Yet Recruiting NCT07481097

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

Conditions: Acute Kidney Injury Due to Sepsis

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Assiut University

Location: Assiut University Hospitals Asyut Asyut Governorate

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 Criteria

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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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07481097). StuddyBuddy aggregates publicly available trial information.