N/LP Ratio as Predictor of Mortality in Septic AKI Patients

October 1, 2022 updated by: Mahmoud Kamel Mohamed Abd elhaq

Neutrophils to Lymphocytes and Platelets Ratio (N/LP) as Predictor of Mortality in Septic- Acute Kidney Injury Patients

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

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mahmoud Kamel Mohamed Abd elhaq, Resident
  • Phone Number: 01114757615 01145468310
  • Email: Hamoudkamel01@gmail.com

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients aged 18 and older

Diagnosed as AKI due to sepsis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neutrophils to Lymphocytes and platelets ratio (N/LP) as predictor of mortality in septic- acute kidney injury patients
Time Frame: Baseline
The N/LP ratio at icu admission was independently associated with in-hospital mortality in septic-AKI patients the assessment of this ratio is straight forward from routine blood analysis in ICU patients useful in identifying patients at risk of mortality The N/LP ratio at icu admission was independently associated with in-hospital mortality in septic-AKI patients the assessment of this ratio is straight forward from routine blood analysis in ICU patients useful in identifying patients at risk of mortality
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahmoud Kamel Mohamed Abd elhaq

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 25, 2022

Primary Completion (Anticipated)

February 25, 2024

Study Completion (Anticipated)

March 25, 2025

Study Registration Dates

First Submitted

September 24, 2022

First Submitted That Met QC Criteria

September 24, 2022

First Posted (Actual)

September 29, 2022

Study Record Updates

Last Update Posted (Actual)

October 4, 2022

Last Update Submitted That Met QC Criteria

October 1, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N/LP in septic AKI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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