SepsisNCT06586372
CRP,CRP/Alb Ratio, N/L Ratio in Predictors of Both Systemic Infection and Survival in Patient With Sepsis in Assiut University Hospitals
An observational study of Sepsis and Systemic Infection, run by Assiut University.
Trial 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 ? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Systemic Infection
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 30 Nov 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the patients will be diagnosed according to international criteria and sepsis-3 definitions
Who may be able to join
- Patients with sepsis with normal blood pressure
Who cannot join
- 1) Patients with history of corticosteroid therapy or antibiotic use before admission.
- 2) Patients with hematologic disorders, malignant diseases, chemotherapy or radiotherapy within the previous month .
- 3)Patients with shock
Trial locations and contacts
No sites are listed yet.
About this study
Official title: CRP,CRP/Alb Ratio, N/L Ratio in Predictors of Both Systemic Infection and Survival in Patient With Sepsis
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 ?
Read the detailed description
Sepsis is an unusual systemic reaction to what is sometimes an otherwise ordinary infection, and it probably represents a pattern of response by the immune system to injury. A hyper-inflammatory response is followed by an immunosuppressive phase during which multiple organ dysfunction is present and the patient is susceptible to nosocomial infection.
A biomarker describes a measurable indicator of a patient\'s clinical condition that can be measured accurately and reproducibly. Biomarkers offer utility for diagnosis, prognosis, early disease recognition, risk stratification, appropriate treatment (theranostics), and trial enrichment for patients with sepsis or suspected sepsis C-reactive protein (CRP) is an acute-phase protein that is produced following stimulation by various cytokines in response to infection, ischemia, trauma, and other inflammatory conditions . High CRP levels have been studied in relation to prognosis and mortality in critically ill patients . On the other hand, low serum albumin is known to be associated with poor prognosis and mortality . Based on this knowledge, we speculated that the ratio of CRP to albumin could be used as a predictive marker for mortality.
Recently, the CRP/albumin ratio, a combination of markers for systemic inflammation and nutritional status, has been extensively studied as an independent prognostic marker in patients with infection, malignancy, and other diseases . However, there are relatively few studies conducted focusing on critical care patients in the ICU Among the plethora of biomarkers available to clinicians investigating septic patients in the Emergency Department (ED), white blood cell count (WBC) are always taken into consideration due to their availability and low cost. Serial measurement of RP, is useful for clinicians' decision-making, as its serum levels correlate with the syndrome evo-lution .Neutrophil-to-lymphocyte ratio (NLR) calculated from the complete blood count seems to be a reasonable tool for assessment during the sepsis course (8, 9).
- Conditions
- Sepsis, Systemic Infection
- Medical subject headings
- Sepsis, Toxemia
What is being measured
The primary outcome is the main question the study is designed to answer.
CRP level in patients with sepsis
Measured: baseline
CRP/Alb ratio level in patients with sepsis
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Ahmed Mohamed Gomaa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586372
- Sponsor's protocol ID
- predictors /Survival /sepsis
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25190127Saito 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.
PubMed 29270656Ranzani 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.
PubMed 23555017Artero 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.
PubMed 20149587Lobo 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.
PubMed 12796187Villacorta 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.
PubMed 17589635Ho 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.
PubMed 16990094Thijs LG, Hack CE. Time course of cytokine levels in sepsis. Intensive Care Med. 1995 Nov;21 Suppl 2:S258-63. doi: 10.1007/BF01740764.
PubMed 8636533Barichello 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.
PubMed 34991675Faix JD. Biomarkers of sepsis. Crit Rev Clin Lab Sci. 2013 Jan-Feb;50(1):23-36. doi: 10.3109/10408363.2013.764490.
PubMed 23480440Rello 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.
PubMed 29022217
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRP,CRP/Alb Ratio, N/L Ratio in Predictors of Both Systemic Infection and Survival in Patient With Sepsis
- ClinicalTrials.gov ID
- NCT06586372
- Acronym / sponsor ID
- predictors /Survival /sepsis
- Conditions
- Sepsis, Systemic Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 ?
Detailed description
Sepsis is an unusual systemic reaction to what is sometimes an otherwise ordinary infection, and it probably represents a pattern of response by the immune system to injury. A hyper-inflammatory response is followed by an immunosuppressive phase during which multiple organ dysfunction is present and the patient is susceptible to nosocomial infection.
A biomarker describes a measurable indicator of a patient\'s clinical condition that can be measured accurately and reproducibly. Biomarkers offer utility for diagnosis, prognosis, early disease recognition, risk stratification, appropriate treatment (theranostics), and trial enrichment for patients with sepsis or suspected sepsis C-reactive protein (CRP) is an acute-phase protein that is produced following stimulation by various cytokines in response to infection, ischemia, trauma, and other inflammatory conditions . High CRP levels have been studied in relation to prognosis and mortality in critically ill patients . On the other hand, low serum albumin is known to be associated with poor prognosis and mortality . Based on this knowledge, we speculated that the ratio of CRP to albumin could be used as a predictive marker for mortality.
Recently, the CRP/albumin ratio, a combination of markers for systemic inflammation and nutritional status, has been extensively studied as an independent prognostic marker in patients with infection, malignancy, and other diseases . However, there are relatively few studies conducted focusing on critical care patients in the ICU Among the plethora of biomarkers available to clinicians investigating septic patients in the Emergency Department (ED), white blood cell count (WBC) are always taken into consideration due to their availability and low cost. Serial measurement of RP, is useful for clinicians' decision-making, as its serum levels correlate with the syndrome evo-lution .Neutrophil-to-lymphocyte ratio (NLR) calculated from the complete blood count seems to be a reasonable tool for assessment during the sepsis course (8, 9).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the patients will be diagnosed according to international criteria and sepsis-3 definitions
Key inclusion criteria (1 listed)
- Patients with sepsis with normal blood pressure
Key exclusion criteria (3 listed)
- 1) Patients with history of corticosteroid therapy or antibiotic use before admission.
- 2) Patients with hematologic disorders, malignant diseases, chemotherapy or radiotherapy within the previous month .
- 3)Patients with shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CRP level in patients with sepsis
Time frame: baseline
CRP/Alb ratio level in patients with sepsis
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Results publication: PubMed 25190127Kinoshita 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.
- Results publication: PubMed 29270656Saito 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.
- Results publication: PubMed 23555017Ranzani 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.
- Results publication: PubMed 20149587Artero 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.
- Results publication: PubMed 12796187Lobo 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.
- Results publication: PubMed 17589635Villacorta 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.
- Results publication: PubMed 16990094Ho 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.
- Results publication: PubMed 8636533Thijs LG, Hack CE. Time course of cytokine levels in sepsis. Intensive Care Med. 1995 Nov;21 Suppl 2:S258-63. doi: 10.1007/BF01740764.
- Results publication: PubMed 34991675Barichello 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.
- Results publication: PubMed 23480440Faix JD. Biomarkers of sepsis. Crit Rev Clin Lab Sci. 2013 Jan-Feb;50(1):23-36. doi: 10.3109/10408363.2013.764490.
- Results publication: PubMed 29022217Rello 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.
- Individual participant dataSharing planned: No
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Systemic Infection, run by Assiut University.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esraa Ahmed Mohamed Gomaa, resident doctors (+201155339230, esr43872@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRP level in patients with sepsis (time frame: baseline). The study lists 2 primary outcomes in all. 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 NCT06586372, which also lists 11 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 19 Sep 2024.