NCT05887960

Brief Summary

The aim of this study is to establish NLR, MLR as a good predictors for outcome of CKD including hemodialysis and CKD stage (4-5) patients as regard inflammation, malnutrition and anemia on cardiovascular complication.

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 Jun 2023

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

April 25, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

June 5, 2023

Status Verified

May 1, 2023

Enrollment Period

1.1 years

First QC Date

April 25, 2023

Last Update Submit

May 24, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Impact of neutrophil lymphocyte and monocyte lymphocyte ratio on chronic kidney disease patients outcome

    Neutrophil to lymphocyte ratio and monocyte to lymphocyte ratio in addition to subtypes of monocytes will be measured in healthy persons, CKD patients stage (4-5) and in chronic hemodialysis patients and use it as inflamamtory markers as well as it's a good predictors for cardiovascular complications and what's the impact of it's ratio degree on CKD patients outcome

    baseline

Study Arms (3)

1

healthy persons to see normal ratio of of neutrophil lymphocyte and monocyte lymphocyte

Other: CBC and flow cytometry test for monocyte

2

CKD patients stage (4-5) not on dialysis to see impact of (NLR) and (MLR) as regard inflamation and cardiovascular complications

Other: CBC and flow cytometry test for monocyte

3

patients ESRD on maintenance hemodialysis compared with CKD pre dialysis patents and see if hemodialysis is better for removal toxic granules and inflamatory markers caused by CKD

Other: CBC and flow cytometry test for monocyte

Interventions

all groups assigned Cbc with leukocyte differential and flow cytometry for monocyte population

123

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

healthy persons as control group patients with chronic kidney disease (CKD) stage 4-5 (not on dialysis) patients ESRD on maintenance hemodialysis

You may qualify if:

  • \- Hemodialysis patients \> 18 years
  • \< 60 years old
  • CKD stage (4-5) not on dialysis

You may not qualify if:

  • o Recent acute coronary or cerebrovascular accident
  • Autoimmune diseases
  • Hematological diseases
  • Liver cirrhosis
  • Active or pre-active infection
  • Malignancy
  • Medications as Aspirin, NSAI, immunosuppressive steroid.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Kim JK, Hong CW, Park MJ, Song YR, Kim HJ, Kim SG. Increased Neutrophil Extracellular Trap Formation in Uremia Is Associated with Chronic Inflammation and Prevalent Coronary Artery Disease. J Immunol Res. 2017;2017:8415179. doi: 10.1155/2017/8415179. Epub 2017 Mar 27.

    PMID: 28523279BACKGROUND
  • Girndt M, Trojanowicz B, Ulrich C. Monocytes in Uremia. Toxins (Basel). 2020 May 21;12(5):340. doi: 10.3390/toxins12050340.

    PMID: 32455723BACKGROUND
  • Ramirez R, Carracedo J, Merino A, Soriano S, Ojeda R, Alvarez-Lara MA, Martin-Malo A, Aljama P. CD14+CD16+ monocytes from chronic kidney disease patients exhibit increased adhesion ability to endothelial cells. Contrib Nephrol. 2011;171:57-61. doi: 10.1159/000327134. Epub 2011 May 23.

  • Chapter 1: Definition and classification of CKD. Kidney Int Suppl (2011). 2013 Jan;3(1):19-62. doi: 10.1038/kisup.2012.64. No abstract available.

  • Kato S, Chmielewski M, Honda H, Pecoits-Filho R, Matsuo S, Yuzawa Y, Tranaeus A, Stenvinkel P, Lindholm B. Aspects of immune dysfunction in end-stage renal disease. Clin J Am Soc Nephrol. 2008 Sep;3(5):1526-33. doi: 10.2215/CJN.00950208. Epub 2008 Aug 13.

  • Sarnak MJ, Jaber BL. Mortality caused by sepsis in patients with end-stage renal disease compared with the general population. Kidney Int. 2000 Oct;58(4):1758-64. doi: 10.1111/j.1523-1755.2000.00337.x.

  • Mansur A, Mulwande E, Steinau M, Bergmann I, Popov AF, Ghadimi M, Beissbarth T, Bauer M, Hinz J. Chronic kidney disease is associated with a higher 90-day mortality than other chronic medical conditions in patients with sepsis. Sci Rep. 2015 May 21;5:10539. doi: 10.1038/srep10539.

  • James MT, Laupland KB, Tonelli M, Manns BJ, Culleton BF, Hemmelgarn BR; Alberta Kidney Disease Network. Risk of bloodstream infection in patients with chronic kidney disease not treated with dialysis. Arch Intern Med. 2008 Nov 24;168(21):2333-9. doi: 10.1001/archinte.168.21.2333.

  • Haag-Weber M, Horl WH. Dysfunction of polymorphonuclear leukocytes in uremia. Semin Nephrol. 1996 May;16(3):192-201.

Related Links

MeSH Terms

Interventions

Blood Cell Count

Intervention Hierarchy (Ancestors)

Cell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Ashraf AN el shazly, profeassor

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdelrahman HA Mohamed, specialist

CONTACT

Samir KM Abdelhamid, professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Impact of neutrophil lymphocyte and monocyte lymphocyte ratio on chronic kidney disease patients outcome

Study Record Dates

First Submitted

April 25, 2023

First Posted

June 5, 2023

Study Start

June 1, 2023

Primary Completion

July 1, 2024

Study Completion

October 1, 2024

Last Updated

June 5, 2023

Record last verified: 2023-05