CRP/Albumin Ratio as a Predictive Inflammatory Marker for Postoperative SIRS and/or Sepsis

NCT ID: NCT06050759

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this observational study is to determine the value of CRP/Albumin Ratio as an inflammatory marker for predicting the development of postoperative Systemic Inflammatory Response Syndrome and/or Sepsis in polytraumatized patients admitted to Intensive care unit.

The main question it aims to answer is whether CRP/Albumin Ratio can be used as predictive inflammatory marker for postoperative Systemic Inflammatory Response Syndrome and/or Sepsis or not.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The development of postoperative Systemic Inflammatory Response Syndrome (SIRS) or Sepsis is a very serious complication that has been associated with high morbidity, mortality, and increased length of inpatient stay.

Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection.

As surgical interventions lead to well-understood metabolic, neuroendocrine, and immune responses, the stress responses to surgery contribute to increased postoperative complications mostly caused by increased levels of Pro-inflammatory cytokines in response to surgical injury, which leads to changes of circulating acute phase proteins, such as albumin and C-reactive protein (CRP).

The CRP to albumin ratio (CAR) is a new index calculated by dividing CRP by the albumin level. It has been assumed to have predictive value in determining morbidity and mortality in many critical diseases.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Crp

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CRP and Albumin level in blood sample

CRP and Albumin levels will be measured from blood samples of the patients to determine CRP/Albumin Ratio

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients classified by American Society of Anesthesiologists physical status (ASA) as I to III.
* Both sex.
* Aged ≥ 18 years old.
* Polytraumatized patients (fulfilling the 'New Berlin definition' of Polytrauma patient which includes Abbreviated Injury Scale (AIS) ≥3 for two or more different body regions with one or more of the following five physiological variables: Disturbed level of consciousness, hypotension, coagulopathy, acidosis and age \>70y).
* Admitted to Intensive Care Unit preoperatively or postoperatively. • Surgical intervention within 48 hours of the onset of Trauma.

Exclusion Criteria

* Patients who used immunosuppressive therapy and chemotherapy.
* Patients with known hematological disorders or malignancy.
* Patients with known liver cirrhosis classified as Child- Pugh C ( serum Albumin \< 2.8 mg/dl or International Normalized Ratio \> 2.2 ) (Tsoris , et al.,2023) or liver cell failure.
* Patients receiving Albumin Supplementation during the period of the study.
* Age \< 18y.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ahmed Samir Said Salem

Assistant Lecturer of Anaesthesia and Intensive care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ahmed Samir, Doctor

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine Ain shams University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

AinShams University Specialized Hospital

Cairo, Abbasia, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.

Reference Type BACKGROUND
PMID: 28101605 (View on PubMed)

Ge X, Cao Y, Wang H, Ding C, Tian H, Zhang X, Gong J, Zhu W, Li N. Diagnostic accuracy of the postoperative ratio of C-reactive protein to albumin for complications after colorectal surgery. World J Surg Oncol. 2017 Jan 10;15(1):15. doi: 10.1186/s12957-016-1092-1.

Reference Type BACKGROUND
PMID: 28069031 (View on PubMed)

Iyengar KP, Venkatesan AS, Jain VK, Shashidhara MK, Elbana H, Botchu R. Risks in the Management of Polytrauma Patients: Clinical Insights. Orthop Res Rev. 2023 Mar 21;15:27-38. doi: 10.2147/ORR.S340532. eCollection 2023.

Reference Type BACKGROUND
PMID: 36974036 (View on PubMed)

Kim MH, Ahn JY, Song JE, Choi H, Ann HW, Kim JK, Kim JH, Jeon YD, Kim SB, Jeong SJ, Ku NS, Han SH, Song YG, Choi JY, Kim YS, Kim JM. The C-Reactive Protein/Albumin Ratio as an Independent Predictor of Mortality in Patients with Severe Sepsis or Septic Shock Treated with Early Goal-Directed Therapy. PLoS One. 2015 Jul 9;10(7):e0132109. doi: 10.1371/journal.pone.0132109. eCollection 2015.

Reference Type BACKGROUND
PMID: 26158725 (View on PubMed)

Singh B, Goyal A, Patel BC. C-Reactive Protein: Clinical Relevance and Interpretation. 2025 May 3. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441843/

Reference Type BACKGROUND
PMID: 28722873 (View on PubMed)

Pape HC, Moore EE, McKinley T, Sauaia A. Pathophysiology in patients with polytrauma. Injury. 2022 Jul;53(7):2400-2412. doi: 10.1016/j.injury.2022.04.009. Epub 2022 May 14.

Reference Type BACKGROUND
PMID: 35577600 (View on PubMed)

Proctor MJ, Horgan PG, Talwar D, Fletcher CD, Morrison DS, McMillan DC. Optimization of the systemic inflammation-based Glasgow prognostic score: a Glasgow Inflammation Outcome Study. Cancer. 2013 Jun 15;119(12):2325-32. doi: 10.1002/cncr.28018. Epub 2013 Apr 10.

Reference Type BACKGROUND
PMID: 23575969 (View on PubMed)

Tsoris A, Marlar CA. Use Of The Child Pugh Score In Liver Disease. 2023 Mar 13. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK542308/

Reference Type BACKGROUND
PMID: 31194448 (View on PubMed)

Uzum Y, Turkkan E. Predictivity of CRP, Albumin, and CRP to Albumin Ratio on the Development of Intensive Care Requirement, Mortality, and Disease Severity in COVID-19. Cureus. 2023 Jan 10;15(1):e33600. doi: 10.7759/cureus.33600. eCollection 2023 Jan.

Reference Type BACKGROUND
PMID: 36788868 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MD134/2023

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.