NCT05636202

Brief Summary

Neutrophil-lymphocyte ratio (NLR), as an inflammatory index, is cheap and easy to obtain, and could be widely used in hospitals at all levels. NLR is a valuable biomarker that is significantly correlated with the status of immune and inflammatory responses. In the past few years, NLR has been continuously and extensively explored in various diseases, and the research progress is considerable. In cardiovascular disease, NLR can predict arrhythmia and short - and long-term mortality in patients with acute coronary syndrome. NLR may be associated with heart failure and valvular heart disease. Moreover, NLR has been shown to be associated with respiratory diseases (such as chronic obstructive pulmonary disease), immune diseases (rheumatoid arthritis and systemic lupus erythematosus), and digestive diseases (acute appendicitis, hepatocellular carcinoma, liver fibrosis, and cirrhosis). Importantly, the study of NLR in sepsis has received much attention in recent years. A 2019 meta-analysis concluded that peripheral white blood cell ratios, including NLR, lymphocyte-to-monocyte ratio (LMR), and platelet-to-lymphocyte ratio (PLR), are associated with clinical outcomes in sepsis and are useful biomarkers of infection. They recommended that NLR be evaluated in future hierarchical models, To clarify its relationship with NLR and clinical outcome and the prognostic value of NLR, it is worth mentioning that NLR has also been found to have the ability to predict the outcome of sepsis. It has been shown that NLR, together with other inflammatory parameters, might be a marker for early detection of sepsis in the intensive care unit. However, a large body of evidence demonstrating the association between NLR and adverse clinical outcomes in sepsis remains controversial. Another study concluded that "no association was found between NLR and 28-day in-hospital mortality in patients with sepsis". In addition, the reliability of NLR on admission in predicting the prognosis of critical illness was also lower than that of traditional markers (including CRP, PCT, serum lactic acid and APACHEⅡ score). This study aimed to retrospectively investigate the early predictive value of inflammation-related parameters in-hospital mortality of septic patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
606

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

November 8, 2022

Completed
23 days until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2022

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

March 18, 2024

Status Verified

October 1, 2022

Enrollment Period

29 days

First QC Date

November 8, 2022

Last Update Submit

March 15, 2024

Conditions

Keywords

sepsisNLRPercentage of neutrophilsPrognosis

Outcome Measures

Primary Outcomes (1)

  • NLR

    NLR values were collected on day 1, day 2, day 3, and day 7 after admission.

    day 1, day2, day 3, and day 7 after admission.

Secondary Outcomes (1)

  • NE%

    on day 1, day 2, day 3, and day 7 after admission.

Study Arms (2)

Survival group

Patients who survived sepsis

Other: No intervention

Death group

Patients who died of sepsis

Other: No intervention

Interventions

There was no intervention in the retrospective study

Death groupSurvival group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with confirmed sepsisc

You may qualify if:

  • Patients with sepsis
  • ICU stay time ≥3 days;

You may not qualify if:

  • \. History of solid organ or bone marrow transplantation;
  • \. Diseases that may affect immune-related indicators, such as autoimmune diseases such as rheumatoid arthritis and SLE, or hematological malignancies such as leukemia and lymphoma;
  • \. Have received radiotherapy or chemotherapy within the past 30 days, or have received immunosuppressive drugs (tripterygium, mycophenolate, cyclophosphamide, FK506, etc.), or have received continuous treatment with more than 10mg of prednisolone/day (or the same dose of other hormones);
  • \. Pregnancy or lactation;c

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Related Publications (18)

  • Huang M, Cai S, Su J. The Pathogenesis of Sepsis and Potential Therapeutic Targets. Int J Mol Sci. 2019 Oct 29;20(21):5376. doi: 10.3390/ijms20215376.

    PMID: 31671729BACKGROUND
  • Ji J, Fan J. Neutrophil in Reverse Migration: Role in Sepsis. Front Immunol. 2021 Mar 15;12:656039. doi: 10.3389/fimmu.2021.656039. eCollection 2021.

    PMID: 33790916BACKGROUND
  • Manz MG, Boettcher S. Emergency granulopoiesis. Nat Rev Immunol. 2014 May;14(5):302-14. doi: 10.1038/nri3660. Epub 2014 Apr 22.

    PMID: 24751955BACKGROUND
  • Grailer JJ, Fattahi F, Dick RS, Zetoune FS, Ward PA. Cutting edge: critical role for C5aRs in the development of septic lymphopenia in mice. J Immunol. 2015 Feb 1;194(3):868-72. doi: 10.4049/jimmunol.1401193. Epub 2014 Dec 24.

    PMID: 25539817BACKGROUND
  • Zahorec R. Neutrophil-to-lymphocyte ratio, past, present and future perspectives. Bratisl Lek Listy. 2021;122(7):474-488. doi: 10.4149/BLL_2021_078.

    PMID: 34161115BACKGROUND
  • Rehman FU, Khan A, Aziz A, Iqbal M, Mahmood SBZ, Ali N. Neutrophils to Lymphocyte Ratio: Earliest and Efficacious Markers of Sepsis. Cureus. 2020 Oct 8;12(10):e10851. doi: 10.7759/cureus.10851.

    PMID: 33178505BACKGROUND
  • Martins EC, Silveira LDF, Viegas K, Beck AD, Fioravantti Junior G, Cremonese RV, Lora PS. Neutrophil-lymphocyte ratio in the early diagnosis of sepsis in an intensive care unit: a case-control study. Rev Bras Ter Intensiva. 2019;31(1):64-70. doi: 10.5935/0103-507X.20190010. Epub 2019 Mar 21.

    PMID: 30916236BACKGROUND
  • Ni J, Wang H, Li Y, Shu Y, Liu Y. Neutrophil to lymphocyte ratio (NLR) as a prognostic marker for in-hospital mortality of patients with sepsis: A secondary analysis based on a single-center, retrospective, cohort study. Medicine (Baltimore). 2019 Nov;98(46):e18029. doi: 10.1097/MD.0000000000018029.

    PMID: 31725679BACKGROUND
  • Russell CD, Parajuli A, Gale HJ, Bulteel NS, Schuetz P, de Jager CPC, Loonen AJM, Merekoulias GI, Baillie JK. The utility of peripheral blood leucocyte ratios as biomarkers in infectious diseases: A systematic review and meta-analysis. J Infect. 2019 May;78(5):339-348. doi: 10.1016/j.jinf.2019.02.006. Epub 2019 Feb 22.

    PMID: 30802469BACKGROUND
  • Huang Z, Fu Z, Huang W, Huang K. Prognostic value of neutrophil-to-lymphocyte ratio in sepsis: A meta-analysis. Am J Emerg Med. 2020 Mar;38(3):641-647. doi: 10.1016/j.ajem.2019.10.023. Epub 2019 Nov 18.

    PMID: 31785981BACKGROUND
  • Kriplani A, Pandit S, Chawla A, de la Rosette JJMCH, Laguna P, Jayadeva Reddy S, Somani BK. Neutrophil-lymphocyte ratio (NLR), platelet-lymphocyte ratio (PLR) and lymphocyte-monocyte ratio (LMR) in predicting systemic inflammatory response syndrome (SIRS) and sepsis after percutaneous nephrolithotomy (PNL). Urolithiasis. 2022 Jun;50(3):341-348. doi: 10.1007/s00240-022-01319-0. Epub 2022 Mar 4.

    PMID: 35246692BACKGROUND
  • Liu Y, Zheng J, Zhang D, Jing L. Neutrophil-lymphocyte ratio and plasma lactate predict 28-day mortality in patients with sepsis. J Clin Lab Anal. 2019 Sep;33(7):e22942. doi: 10.1002/jcla.22942. Epub 2019 Jul 2.

    PMID: 31265174BACKGROUND
  • Chebl RB, Assaf M, Kattouf N, Haidar S, Khamis M, Abdeldaem K, Makki M, Tamim H, Dagher GA. The association between the neutrophil to lymphocyte ratio and in-hospital mortality among sepsis patients: A prospective study. Medicine (Baltimore). 2022 Jul 29;101(30):e29343. doi: 10.1097/MD.0000000000029343.

    PMID: 35905272BACKGROUND
  • Westerdijk K, Simons KS, Zegers M, Wever PC, Pickkers P, de Jager CPC. The value of the neutrophil-lymphocyte count ratio in the diagnosis of sepsis in patients admitted to the Intensive Care Unit: A retrospective cohort study. PLoS One. 2019 Feb 27;14(2):e0212861. doi: 10.1371/journal.pone.0212861. eCollection 2019.

    PMID: 30811475BACKGROUND
  • Zhou T, Zheng N, Li X, Zhu D, Han Y. Prognostic value of neutrophil- lymphocyte count ratio (NLCR) among adult ICU patients in comparison to APACHE II score and conventional inflammatory markers: a multi center retrospective cohort study. BMC Emerg Med. 2021 Feb 23;21(1):24. doi: 10.1186/s12873-021-00418-2.

    PMID: 33622247BACKGROUND
  • Can E, Hamilcikan S, Can C. The Value of Neutrophil to Lymphocyte Ratio and Platelet to Lymphocyte Ratio for Detecting Early-onset Neonatal Sepsis. J Pediatr Hematol Oncol. 2018 May;40(4):e229-e232. doi: 10.1097/MPH.0000000000001059.

    PMID: 29219889BACKGROUND
  • Tian T, Wei B, Wang J. Study of C-reactive protein, procalcitonin, and immunocyte ratios in 194 patients with sepsis. BMC Emerg Med. 2021 Jul 7;21(1):81. doi: 10.1186/s12873-021-00477-5.

    PMID: 34233608BACKGROUND
  • Meshaal MS, Nagi A, Eldamaty A, Elnaggar W, Gaber M, Rizk H. Neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) as independent predictors of outcome in infective endocarditis (IE). Egypt Heart J. 2019 Sep 18;71(1):13. doi: 10.1186/s43044-019-0014-2.

    PMID: 31659520BACKGROUND

MeSH Terms

Conditions

SepsisInfections

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2022

First Posted

December 5, 2022

Study Start

December 1, 2022

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

March 18, 2024

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations