About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Hemodynamic measurements during reduction in Norepinephrine and fluid boli.
Other interventionState 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
Treatment groups
Trial outcomes
Primary outcomes
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)
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)
Secondary outcomes
Renal Resistive Index (RRI): Measured and recorded at T0 (Baseline), T24, T48, and T72 hours
Serum Lactate Clearance: Measured and recorded at T0, T6, T12, and T24 hours.
Serum Creatinine level: Measured and recorded daily for 7 days.
Cumulative Fluid Balance: Calculated and recorded daily for 7 days.
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