Acute Kidney Injury Due to SepsisNCT05559086
N/LP Ratio as Predictor of Mortality in Septic AKI Patients
An observational study of Acute Kidney Injury Due to Sepsis, run by Mahmoud Kamel Mohamed Abd elhaq.
Trial summary
To evaluate the role of Neutrophils to lymphocytes and platelets ratio (N/LP ratio) as a biomarkers for mortality in septic -AKI Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Kidney Injury Due to Sepsis
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 25 Dec 2022to 25 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients aged 18 and older Diagnosed as AKI due to sepsis
Who may be able to join
- aged 18 and older
- 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.
- CRP as marker of sepsis
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Mahmoud Kamel Mohamed Abd elhaq, Resident contact
About this study
Official title: 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
Read the 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.
- Conditions
- Acute Kidney Injury Due to Sepsis
- Keywords
- Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophils to Lymphocytes and platelets ratio (N/LP) as predictor of mortality in septic- acute kidney injury patients
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start25 Dec 2022 (estimated)
- Primary completion25 Feb 2024 (estimated)
- Study completion25 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney Injury Due to SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahmoud Kamel Mohamed Abd elhaq
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahmoud Kamel Mohamed Abd elhaq, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559086
- Sponsor's protocol ID
- N/LP in septic AKI
- Status last verified
- Oct 2022
- First submitted
- 24 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kellum JA, Prowle JR. Paradigms of acute kidney injury in the intensive care setting. Nat Rev Nephrol. 2018 Apr;14(4):217-230. doi: 10.1038/nrneph.2017.184. Epub 2018 Jan 22.
PubMed 29355173Hoste EA, Bagshaw SM, Bellomo R, Cely CM, Colman R, Cruz DN, Edipidis K, Forni LG, Gomersall CD, Govil D, Honore PM, Joannes-Boyau O, Joannidis M, Korhonen AM, Lavrentieva A, Mehta RL, Palevsky P, Roessler E, Ronco C, Uchino S, Vazquez JA, Vidal Andrade E, Webb S, Kellum JA. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. 2015 Aug;41(8):1411-23. doi: 10.1007/s00134-015-3934-7. Epub 2015 Jul 11.
PubMed 26162677Nguyen HB, Smith D. Sepsis in the 21st century: recent definitions and therapeutic advances. Am J Emerg Med. 2007 Jun;25(5):564-71. doi: 10.1016/j.ajem.2006.08.015.
PubMed 17543662Uchino S, Kellum JA, Bellomo R, Doig GS, Morimatsu H, Morgera S, Schetz M, Tan I, Bouman C, Macedo E, Gibney N, Tolwani A, Ronco C; Beginning and Ending Supportive Therapy for the Kidney (BEST Kidney) Investigators. Acute renal failure in critically ill patients: a multinational, multicenter study. JAMA. 2005 Aug 17;294(7):813-8. doi: 10.1001/jama.294.7.813.
PubMed 16106006Chertow GM, Burdick E, Honour M, Bonventre JV, Bates DW. Acute kidney injury, mortality, length of stay, and costs in hospitalized patients. J Am Soc Nephrol. 2005 Nov;16(11):3365-70. doi: 10.1681/ASN.2004090740. Epub 2005 Sep 21.
PubMed 16177006Zarjou A, Agarwal A. Sepsis and acute kidney injury. J Am Soc Nephrol. 2011 Jun;22(6):999-1006. doi: 10.1681/ASN.2010050484. Epub 2011 May 12.
PubMed 21566052Prowle JR, Bellomo R. Sepsis-associated acute kidney injury: macrohemodynamic and microhemodynamic alterations in the renal circulation. Semin Nephrol. 2015 Jan;35(1):64-74. doi: 10.1016/j.semnephrol.2015.01.007.
PubMed 25795500Gomez H, Ince C, De Backer D, Pickkers P, Payen D, Hotchkiss J, Kellum JA. A unified theory of sepsis-induced acute kidney injury: inflammation, microcirculatory dysfunction, bioenergetics, and the tubular cell adaptation to injury. Shock. 2014 Jan;41(1):3-11. doi: 10.1097/SHK.0000000000000052.
PubMed 24346647Martensson J, Bellomo R. Pathophysiology of Septic Acute Kidney Injury. Contrib Nephrol. 2016;187:36-46. doi: 10.1159/000442363. Epub 2016 Feb 8.
PubMed 26881832Abu Alfeilat M, Slotki I, Shavit L. Single emergency room measurement of neutrophil/lymphocyte ratio for early detection of acute kidney injury (AKI). Intern Emerg Med. 2018 Aug;13(5):717-725. doi: 10.1007/s11739-017-1715-8. Epub 2017 Jul 29.
PubMed 28756545Yilmaz H, Cakmak M, Inan O, Darcin T, Akcay A. Can neutrophil-lymphocyte ratio be independent risk factor for predicting acute kidney injury in patients with severe sepsis? Ren Fail. 2015 Mar;37(2):225-9. doi: 10.3109/0886022X.2014.982477. Epub 2014 Nov 14.
PubMed 25394529Pereira M, Rodrigues N, Godinho I, Gameiro J, Neves M, Gouveia J, Costa E Silva Z, Lopes JA. Acute kidney injury in patients with severe sepsis or septic shock: a comparison between the 'Risk, Injury, Failure, Loss of kidney function, End-stage kidney disease' (RIFLE), Acute Kidney Injury Network (AKIN) and Kidney Disease: Improving Global Outcomes (KDIGO) classifications. Clin Kidney J. 2017 Jun;10(3):332-340. doi: 10.1093/ckj/sfw107. Epub 2016 Dec 13.
PubMed 28616211
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutrophils to Lymphocytes and Platelets Ratio (N/LP) as Predictor of Mortality in Septic- Acute Kidney Injury Patients
- ClinicalTrials.gov ID
- NCT05559086
- Acronym / sponsor ID
- N/LP in septic AKI
- Conditions
- Acute Kidney Injury Due to Sepsis
- Keywords
- Acute
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mahmoud Kamel Mohamed Abd elhaqUniversity, hospital or other
- Study start
- 25 Dec 2022 (estimated)
- Primary completion
- 25 Feb 2024 (estimated)
- Study completion
- 25 Mar 2025 (estimated)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 and older Diagnosed as AKI due to sepsis
Key inclusion criteria (6 listed)
- aged 18 and older
- 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.
- CRP as marker of sepsis
Key exclusion criteria (6 listed)
- 1.prerenal and post renal AKI
- 2.Contrast induced AKI
- 3. Drugs induced AKI
- 4.CKD patients and ESRD patient
- 5.Active Lupus, LN
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Background: PubMed 29355173Kellum JA, Prowle JR. Paradigms of acute kidney injury in the intensive care setting. Nat Rev Nephrol. 2018 Apr;14(4):217-230. doi: 10.1038/nrneph.2017.184. Epub 2018 Jan 22.
- Background: PubMed 26162677Hoste EA, Bagshaw SM, Bellomo R, Cely CM, Colman R, Cruz DN, Edipidis K, Forni LG, Gomersall CD, Govil D, Honore PM, Joannes-Boyau O, Joannidis M, Korhonen AM, Lavrentieva A, Mehta RL, Palevsky P, Roessler E, Ronco C, Uchino S, Vazquez JA, Vidal Andrade E, Webb S, Kellum JA. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. 2015 Aug;41(8):1411-23. doi: 10.1007/s00134-015-3934-7. Epub 2015 Jul 11.
- Background: PubMed 17543662Nguyen HB, Smith D. Sepsis in the 21st century: recent definitions and therapeutic advances. Am J Emerg Med. 2007 Jun;25(5):564-71. doi: 10.1016/j.ajem.2006.08.015.
- Background: PubMed 16106006Uchino S, Kellum JA, Bellomo R, Doig GS, Morimatsu H, Morgera S, Schetz M, Tan I, Bouman C, Macedo E, Gibney N, Tolwani A, Ronco C; Beginning and Ending Supportive Therapy for the Kidney (BEST Kidney) Investigators. Acute renal failure in critically ill patients: a multinational, multicenter study. JAMA. 2005 Aug 17;294(7):813-8. doi: 10.1001/jama.294.7.813.
- Background: PubMed 16177006Chertow GM, Burdick E, Honour M, Bonventre JV, Bates DW. Acute kidney injury, mortality, length of stay, and costs in hospitalized patients. J Am Soc Nephrol. 2005 Nov;16(11):3365-70. doi: 10.1681/ASN.2004090740. Epub 2005 Sep 21.
- Background: PubMed 21566052Zarjou A, Agarwal A. Sepsis and acute kidney injury. J Am Soc Nephrol. 2011 Jun;22(6):999-1006. doi: 10.1681/ASN.2010050484. Epub 2011 May 12.
- Background: PubMed 25795500Prowle JR, Bellomo R. Sepsis-associated acute kidney injury: macrohemodynamic and microhemodynamic alterations in the renal circulation. Semin Nephrol. 2015 Jan;35(1):64-74. doi: 10.1016/j.semnephrol.2015.01.007.
- Background: PubMed 24346647Gomez H, Ince C, De Backer D, Pickkers P, Payen D, Hotchkiss J, Kellum JA. A unified theory of sepsis-induced acute kidney injury: inflammation, microcirculatory dysfunction, bioenergetics, and the tubular cell adaptation to injury. Shock. 2014 Jan;41(1):3-11. doi: 10.1097/SHK.0000000000000052.
- Background: PubMed 26881832Martensson J, Bellomo R. Pathophysiology of Septic Acute Kidney Injury. Contrib Nephrol. 2016;187:36-46. doi: 10.1159/000442363. Epub 2016 Feb 8.
- Background: PubMed 28756545Abu Alfeilat M, Slotki I, Shavit L. Single emergency room measurement of neutrophil/lymphocyte ratio for early detection of acute kidney injury (AKI). Intern Emerg Med. 2018 Aug;13(5):717-725. doi: 10.1007/s11739-017-1715-8. Epub 2017 Jul 29.
- Background: PubMed 25394529Yilmaz H, Cakmak M, Inan O, Darcin T, Akcay A. Can neutrophil-lymphocyte ratio be independent risk factor for predicting acute kidney injury in patients with severe sepsis? Ren Fail. 2015 Mar;37(2):225-9. doi: 10.3109/0886022X.2014.982477. Epub 2014 Nov 14.
- Background: PubMed 28616211Pereira M, Rodrigues N, Godinho I, Gameiro J, Neves M, Gouveia J, Costa E Silva Z, Lopes JA. Acute kidney injury in patients with severe sepsis or septic shock: a comparison between the 'Risk, Injury, Failure, Loss of kidney function, End-stage kidney disease' (RIFLE), Acute Kidney Injury Network (AKIN) and Kidney Disease: Improving Global Outcomes (KDIGO) classifications. Clin Kidney J. 2017 Jun;10(3):332-340. doi: 10.1093/ckj/sfw107. Epub 2016 Dec 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Kamel Mohamed Abd elhaq, Resident contact
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury Due to Sepsis, run by Mahmoud Kamel Mohamed Abd elhaq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Kamel Mohamed Abd elhaq, Resident (01145468310 ext. 01114757615, Hamoudkamel01@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutrophils to Lymphocytes and platelets ratio (N/LP) as predictor of mortality in septic- acute kidney injury patients (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05559086, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.