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SepsisNCT05636202

The Role of NLR in the Diagnosis and Prognosis of Sepsis

An observational study of Sepsis and Infections, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Sepsis, Infections
How many people
606 participants
Where
1 siteChina
Study dates
1 Dec 2022to 30 Dec 2022
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 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with confirmed sepsisc

Who may be able to join

  • 1.Patients with sepsis
  • 2.ICU stay time ≥3 days;

Who cannot join

  • 1. History of solid organ or bone marrow transplantation;
  • 2. 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;
  • 3. 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);
  • 4. Pregnancy or lactation;c

Trial locations and contacts

1 site in 1 country.

China1 site
  • Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

Other trials in China

About this study

Official title: The Early Predictive Roles of NLR and NE% in In-hospital Mortality of Septic Patients: a Single-center 13-year Retrospective Study

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.

Read the detailed description

Sepsis is defined as a life-threatening organ dysfunction caused by the host's malfunctioning response to infection, which has become one of the major problems in the world's public health. The development of effective biomarkers for the diagnosis of sepsis is undoubtedly helpful for us to timely and accurately understand the diagnosis, progression, and prognosis of sepsis.

The neutrophil-to-lymphocyte ratio (NLR), as an inflammatory indicator, is inexpensive and easily accessible parameter and could be widely used. In severe infectious diseases, particularly in sepsis, a substantial increase in peripheral blood neutrophils has been discovered, which reflects the severity of the inflammatory response. Neutrophil reverse migration following the initial neutrophil infiltration into inflammatory scenarios may further exacerbate the increase in the peripheral blood neutrophils. Lymphocyte apoptosis-induced reduction of peripheral blood lymphocytes is a significant feature of sepsis that could lead to adaptive immunosuppression. NLR is a cheap and rapidly available predictor of sepsis and has shown a significant correlation with other relatively expensive and non-rapidly existing markers of inflammation and sepsis.

Importantly, research on NLR in sepsis has received wide attention in recent years. NLR within 24 hours before intensive care unit (ICU) admission could be used as a marker for early diagnosis of sepsis. In addition to the diagnostic value of NLR, it is worth mentioning that NLR has also been found to have the ability of predicting the prognosis of sepsis. A meta-analysis in 2019 indicates that peripheral blood leucocyte ratios, including NLR, lymphocyte-to-monocyte ratio (LMR) and platelet-to-lymphocyte ratios (PLR), could be useful infection biomarkers and associated with clinical prognosis of sepsis. A meta-analysis in 2020 also indicates that the higher NLR was linked to poor prognosis in patients with sepsis (n = 10,685) (hazard ratio (HR) = 1.75). NLR at admission is shown to be an independent predictor of in-hospital mortality of septic patients (n = 174). NLR, PLR and LMR can be useful predictors for early identification of post-percutaneous nephrolithotomy (PNL) sepsis. However, the exact role of NLR in the early prediction of the prognosis of septic patients remain controversial. No correlation was found between NLR at admission of emergency department and 28-day hospital mortality of septic patients. NLR at admission is less suitable than conventional inflammatory markers C-reactive protein (CRP) and procalcitonin (PCT) to detect the presence of sepsis in ICU patients. NLR at ICU admission is also less reliable than CRP, PCT, lactic acid and acute physiology and chronic health evaluation (APACHE Ⅱ) score in assessing the severity and in predicting 28-day mortality of critical illness.

In this study, the investigators enrolled septic patients to determine the role of NLR in the early prediction of in-hospital mortality of patients with sepsis. In addition, considering that PLR, neutrophil percentage (NE%) and monocyte to lymphocyte ratio (MLR) have been confirmed to be also associated with the mortality of patients with sepsis, while retrospectively analyzing the role of NLR, the investigators also studied the roles of PLR, MLR, neutrophil percentage, and other inflammation-related parameters on the first, second, third, and seventh days after hospitilization in the in-hospital mortality of septic patients.

Conditions
Sepsis, Infections
Being tested
No intervention
Keywords
sepsis, NLR, Percentage of neutrophils, Prognosis
Medical subject headings
Sepsis, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    There was no intervention in the retrospective study

Study groups in NCT05636202
Study groupRoleWhat they receive
Survival groupPatients who survived sepsis
Receives: Other: No intervention
Death groupPatients who died of sepsis
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. NLR

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

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

Secondary outcomes (1)
  1. NE%

    NE% were collected on day 1, day 2, day 3, and day 7 after admission.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2022
  2. Study start1 Dec 2022
  3. Primary completion30 Dec 2022
  4. Study completion30 Dec 2022

Resources

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
Retrospective
Enrolment
606 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05636202
Sponsor's protocol ID
NLR01
Status last verified
Oct 2022
First submitted
8 Nov 2022
Last updated
18 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31671729
  • 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.

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

    PubMed 24751955
  • 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.

    PubMed 25539817
  • 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.

    PubMed 34161115
  • 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.

    PubMed 33178505
  • 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.

    PubMed 30916236
  • 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.

    PubMed 31725679
  • 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.

    PubMed 30802469
  • 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.

    PubMed 31785981
  • 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.

    PubMed 35246692
  • 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.

    PubMed 31265174
  • 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.

    PubMed 35905272
  • 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.

    PubMed 30811475
  • 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.

    PubMed 33622247

Questions about this trial

What is this clinical trial studying?

An observational study of Sepsis and Infections, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

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 2 inclusion and 4 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: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NLR (time frame: day 1, day2, day 3, and day 7 after admission.). 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 NCT05636202, which also lists 18 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 18 Mar 2024.

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