Clinical trial NCT05559086: N/LP Ratio as Predictor of Mortality in Septic AKI Patients
Official title: Neutrophils to Lymphocytes and Platelets Ratio (N/LP) as Predictor of Mortality in Septic- Acute Kidney Injury Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Kidney Injury Due to Sepsis
Keywords: Acute
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18 and older

Diagnosed as AKI due to sepsis

Brief summary: To evaluate the role of Neutrophils to lymphocytes and platelets ratio (N/LP ratio) as a biomarkers for mortality in septic -AKI

Detailed description: Acute kidney injury (AKI) is a rapid deteriorattion in renal function,and AKI is frequent in hospitalized patients and its incidence is higher in critically ill patients, in whom the leading cause of AKI is sepsis,.Sepsis is the systemic inflammatory response to an infectious insult, . Septic-AKI patients have higher severity scores at admission, more non-renal organ failure and requirement of vasopressors and mechanical ventilation.

AKI has been associated with longer hospital stays, in-hospital mortality, progression to chronic kidney disease . Septic-AKI also has higher short-term mortality rate, prolonged length of hospital stays and higher probability of renal function recovery at hospital discharge.Therefore, it is important to detect predictors of AKI and mortality to prevent, diagnose and treat this complication..

A recent study demonstrated that septic AKI patients have higher detectable plasma and urine neutrophil gelatinase associated lipocalin (NGAL) compared with nonseptic AKI patients.The utility of these and other novel biomarkers including cystatin C, liver fatty acid-binding protein (L-FABP), and netrin-1 for early detection of sepsis-induced AKI is very encouraging and may have prognostic as well as pathogenetic implications. For instance, urinary liver fatty acid-binding protein (L-FABP) is significantly higher in AKI than non-AKI in adult ICU patients. On the other hand, netrin-1, is excreted in the urine as early as 1 hour after injury reaching approximately 30-fold increase by 3 hours . The utility of such biomarkers may be of particular importance because early detection of AKI will allow for appropriate and timely interventions that would significantly decrease morbidity and mortality related to AKI.

Recent studies have shown that the level of urinary biomarkers like interleukin-18 (IL-8), neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1) increases in the early stage of AKI, prior to creatinine elevation and histological changes, which may contribute to the early detection of AKI. these are sensitive and specific biomarkers for the early diagnosis of AKI in septic patients

Indeed, the role of intrarenal and systemic inflammation appears to be significant in the pathophysiology of septic-AKI and in the associated multi-organ dysfunction

For septic AKI treatment options are limited, and mortality remains high.

The neutrophil to lymphocyte ratio (N/L ratio) and neutrophil to lymphocytes and platelets ratio (N/LP ratio) have been associated with AKI in the emergency setting ,sepsis, contrast induced-AKI, cardiovascular surgery and abdominal surgery. These are easily calculated, effective , and inexpensive markers of systemic inflammation which might be promising in AKI patients. The NL ratio was a predictive of mortality thus, platelet count was incorporated in the ratio to increase its sensitivity in predicting patient outcomes as In the early phases of sepsis platelet/neutrophils complexes are raised, and reduced in severe and complicated sepsis due to peripheral sequestration or sepsis-associated thrombocytopenia.

The prognostic ability of the neutrophils to lymphocytes and platelets ratio (N/LP ratio) has not previously been evaluated in septic-AKI. the N/LP ratio at admission was an independent predictor of mortality in patients who develop septic-AKI within the first week of admission. More importantly, a N/LP ratio lower than 14 is predictive of patient survival, which further reflects that lower inflammation is associated with lower mortality in critically ill septic patients and a higher N/LP ratio at ICU admission was independently associated with in-hospital mortality in septic-AKI patients Thus, highlighting the role of the N/LP ratio as a significant marker of systemic inflammatory response at ICU admission.

Eligibility criteria: Inclusion Criteria:

1. aged 18 and older
2. Diagnosed as Septic -AKI

   AKI was diagnosed according to kdigo definition and staging

   Sepsis was diagnosed according to the third international consensus definitions as an acute change in total Sequential Organ Failure Assessment (SOFA) score ≥2 points consequent to the infection.
3. CRP as marker of sepsis
4. CBC as marker of sepsis, N/LP ratio is calculated as: (Neutrophil count × 100)/(Lymphocyte count × Platelet count). the N/LP ratio lower than 14 is predictive of patient survival, which further reflects that lower inflammation is associated with lower mortality in critically ill septic patients. Thus, highlighting the role of the N/LP ratio as a significant marker of systemic inflammatory response at ICU admission.

Exclusion Criteria:

* 1.prerenal and post renal AKI

  2.Contrast induced AKI

  3. Drugs induced AKI

  4.CKD patients and ESRD patient

  5.Active Lupus, LN

  6.Malignancies

Primary outcomes:
measure: Neutrophils to Lymphocytes and platelets ratio (N/LP) as predictor of mortality in septic- acute kidney injury patients
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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