NCT05559086

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 29, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

December 25, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2025

Completed
Last Updated

October 4, 2022

Status Verified

October 1, 2022

Enrollment Period

1.2 years

First QC Date

September 24, 2022

Last Update Submit

October 1, 2022

Conditions

Acute Kidney Injury Due to Sepsis

Keywords

Acute

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 18 and older Diagnosed as AKI due to sepsis

You may qualify if:

  • 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.

You may not qualify if:

  • prerenal and post renal AKI
  • Contrast induced AKI
  • \. Drugs induced AKI
  • CKD patients and ESRD patient
  • Active Lupus, LN
  • Malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • 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.

    PMID: 29355173BACKGROUND

  • Hoste 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.

    PMID: 26162677BACKGROUND

  • Nguyen 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.

    PMID: 17543662BACKGROUND

  • Uchino 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.

    PMID: 16106006BACKGROUND

  • Chertow 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.

    PMID: 16177006BACKGROUND

  • Zarjou 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.

    PMID: 21566052BACKGROUND

  • Prowle 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.

    PMID: 25795500BACKGROUND

  • Gomez 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.

    PMID: 24346647BACKGROUND

  • Martensson J, Bellomo R. Pathophysiology of Septic Acute Kidney Injury. Contrib Nephrol. 2016;187:36-46. doi: 10.1159/000442363. Epub 2016 Feb 8.

    PMID: 26881832BACKGROUND

  • Abu 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.

    PMID: 28756545BACKGROUND

  • Yilmaz 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.

    PMID: 25394529BACKGROUND

  • Pereira 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.

    PMID: 28616211BACKGROUND

Central Study Contacts

Mahmoud Kamel Mohamed Abd elhaq, Resident

CONTACT

01145468310Hamoudkamel01@gmail.com

Essam Mohamed abdelaziz, MD

CONTACT

01009699081Essam.nephro@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 24, 2022

First Posted

September 29, 2022

Study Start

December 25, 2022

Primary Completion

February 25, 2024

Study Completion

March 25, 2025

Last Updated

October 4, 2022

Record last verified: 2022-10