NCT06050759

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

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

September 16, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

11 months

First QC Date

September 16, 2023

Last Update Submit

March 28, 2025

Conditions

Keywords

CRP/ALBUMIN RatioSystemic inflammatory response syndromeSepsispostoperative

Outcome Measures

Primary Outcomes (1)

  • Evaluate the relation of CRP/ albumin ratio to the prediction of postoperative SIRS or sepsis in polytrauma patients.

    Evaluate the relation of CRP/ albumin ratio to the prediction of postoperative SIRS or sepsis in polytrauma patients.

    The patients will be evaluated for 5 days postoperatively

Interventions

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

Eligibility Criteria

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

* 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AinShams University Specialized Hospital

Cairo, Abbasia, Egypt

Location

Related Publications (9)

  • 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.

    PMID: 28101605BACKGROUND
  • 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.

    PMID: 28069031BACKGROUND
  • 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.

    PMID: 36974036BACKGROUND
  • 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.

    PMID: 26158725BACKGROUND
  • 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/

    PMID: 28722873BACKGROUND
  • 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.

    PMID: 35577600BACKGROUND
  • 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.

    PMID: 23575969BACKGROUND
  • 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/

    PMID: 31194448BACKGROUND
  • 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.

    PMID: 36788868BACKGROUND

MeSH Terms

Conditions

Systemic Inflammatory Response SyndromeSepsis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

InflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockInfections

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Ahmed Samir, Doctor

    Faculty of Medicine Ain shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Anaesthesia and Intensive care

Study Record Dates

First Submitted

September 16, 2023

First Posted

September 22, 2023

Study Start

December 1, 2023

Primary Completion

November 1, 2024

Study Completion

December 30, 2024

Last Updated

April 2, 2025

Record last verified: 2025-03

Locations