NCT06586372

Brief Summary

the goal of this study is to asses the value of biomarker (CRP, CRP/Alb ratio, N/L ratio) in predictor of the outcome in normotensive patients with sepsis. The main question it aims to answer is: Does biomarker (CRP, CRP/Alb ratio, N/L ratio) can predict the outcome in patients with sepsis ?

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2024

Status
not yet recruiting

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 4, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.1 years

First QC Date

September 4, 2024

Last Update Submit

September 4, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • CRP level in patients with sepsis

    baseline

  • CRP/Alb ratio level in patients with sepsis

    baseline

Eligibility Criteria

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

the patients will be diagnosed according to international criteria and sepsis-3 definitions

You may qualify if:

  • Patients with sepsis with normal blood pressure

You may not qualify if:

  • \) Patients with history of corticosteroid therapy or antibiotic use before admission.
  • \) Patients with hematologic disorders, malignant diseases, chemotherapy or radiotherapy within the previous month .
  • )Patients with shock

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • Kinoshita A, Onoda H, Imai N, Iwaku A, Oishi M, Tanaka K, Fushiya N, Koike K, Nishino H, Matsushima M. The C-reactive protein/albumin ratio, a novel inflammation-based prognostic score, predicts outcomes in patients with hepatocellular carcinoma. Ann Surg Oncol. 2015 Mar;22(3):803-10. doi: 10.1245/s10434-014-4048-0. Epub 2014 Sep 5.

    PMID: 25190127BACKGROUND
  • Saito H, Kono Y, Murakami Y, Shishido Y, Kuroda H, Matsunaga T, Fukumoto Y, Osaki T, Ashida K, Fujiwara Y. Prognostic Significance of the Preoperative Ratio of C-Reactive Protein to Albumin and Neutrophil-Lymphocyte Ratio in Gastric Cancer Patients. World J Surg. 2018 Jun;42(6):1819-1825. doi: 10.1007/s00268-017-4400-1.

    PMID: 29270656BACKGROUND
  • Ranzani OT, Zampieri FG, Forte DN, Azevedo LC, Park M. C-reactive protein/albumin ratio predicts 90-day mortality of septic patients. PLoS One. 2013;8(3):e59321. doi: 10.1371/journal.pone.0059321. Epub 2013 Mar 12.

    PMID: 23555017BACKGROUND
  • Artero A, Zaragoza R, Camarena JJ, Sancho S, Gonzalez R, Nogueira JM. Prognostic factors of mortality in patients with community-acquired bloodstream infection with severe sepsis and septic shock. J Crit Care. 2010 Jun;25(2):276-81. doi: 10.1016/j.jcrc.2009.12.004. Epub 2010 Feb 10.

    PMID: 20149587BACKGROUND
  • Lobo SM, Lobo FR, Bota DP, Lopes-Ferreira F, Soliman HM, Melot C, Vincent JL. C-reactive protein levels correlate with mortality and organ failure in critically ill patients. Chest. 2003 Jun;123(6):2043-9. doi: 10.1378/chest.123.6.2043.

    PMID: 12796187BACKGROUND
  • Villacorta H, Masetto AC, Mesquita ET. C-reactive protein: an inflammatory marker with prognostic value in patients with decompensated heart failure. Arq Bras Cardiol. 2007 May;88(5):585-9. doi: 10.1590/s0066-782x2007000500014. English, Portuguese.

    PMID: 17589635BACKGROUND
  • Ho KM, Dobb GJ, Lee KY, Towler SC, Webb SA. C-reactive protein concentration as a predictor of intensive care unit readmission: a nested case-control study. J Crit Care. 2006 Sep;21(3):259-65. doi: 10.1016/j.jcrc.2006.01.005.

    PMID: 16990094BACKGROUND
  • Thijs LG, Hack CE. Time course of cytokine levels in sepsis. Intensive Care Med. 1995 Nov;21 Suppl 2:S258-63. doi: 10.1007/BF01740764.

    PMID: 8636533BACKGROUND
  • Barichello T, Generoso JS, Singer M, Dal-Pizzol F. Biomarkers for sepsis: more than just fever and leukocytosis-a narrative review. Crit Care. 2022 Jan 6;26(1):14. doi: 10.1186/s13054-021-03862-5.

    PMID: 34991675BACKGROUND
  • Faix JD. Biomarkers of sepsis. Crit Rev Clin Lab Sci. 2013 Jan-Feb;50(1):23-36. doi: 10.3109/10408363.2013.764490.

    PMID: 23480440BACKGROUND
  • Rello J, Valenzuela-Sanchez F, Ruiz-Rodriguez M, Moyano S. Sepsis: A Review of Advances in Management. Adv Ther. 2017 Nov;34(11):2393-2411. doi: 10.1007/s12325-017-0622-8. Epub 2017 Oct 11.

    PMID: 29022217BACKGROUND

MeSH Terms

Conditions

SepsisToxemia

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Esraa Ahmed Mohamed Gomaa, resident doctors

CONTACT

Nour Eldine Abd-Elaseame, professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

September 4, 2024

First Posted

September 19, 2024

Study Start

October 1, 2024

Primary Completion

October 30, 2025

Study Completion

November 30, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share