AzTrials
AzTrials

CrpNCT06050759

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

An observational study of Crp, run by Ain Shams University at 1 site in Egypt.

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

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crp
What is being tested?
CRP and Albumin level in blood sample
How many people
100 participants
Where
1 siteEgypt
Study dates
1 Dec 2023to 30 Dec 2024
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: * 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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • AinShams University Specialized Hospital

    Cairo, Abbasia

Other trials in Egypt

About this study

Official title: C-Reactive Protein / Albumin Ratio as a Predictive Inflammatory Marker for Postoperative Systemic Inflammatory Response Syndrome and/or Sepsis in Polytraumatized Patients in ICU

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.

Read the detailed description

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
Crp
Being tested
CRP and Albumin level in blood sample
Keywords
CRP/ALBUMIN Ratio, Systemic inflammatory response syndrome, Sepsis, postoperative
Medical subject headings
Systemic Inflammatory Response Syndrome, Sepsis

What participants receive

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

  • CRP and Albumin level in blood sampleDiagnostic test

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

What is being measured

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

  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.

    Measured: The patients will be evaluated for 5 days postoperatively

Timeline

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

  1. First posted22 Sep 2023
  2. Study start1 Dec 2023
  3. Primary completion1 Nov 2024
  4. Study completion30 Dec 2024

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
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06050759
Sponsor's protocol ID
MD134/2023
Status last verified
Mar 2025
First submitted
16 Sep 2023
Last updated
2 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 28101605

  • 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.

    PubMed 28069031

  • 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.

    PubMed 36974036

  • 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.

    PubMed 26158725

  • Singh B, Goyal A, Patel BC. C-Reactive Protein: Clinical Relevance and Interpretation. 2025 May 3. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441843/

    PubMed 28722873

  • 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.

    PubMed 35577600

  • 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.

    PubMed 23575969

  • Tsoris A, Marlar CA. Use Of The Child Pugh Score In Liver Disease. 2023 Mar 13. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK542308/

    PubMed 31194448

  • 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.

    PubMed 36788868

Questions about this trial

What is this clinical trial studying?

An observational study of Crp, run by Ain Shams University at 1 site in Egypt.

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 5 inclusion and 5 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 2 Apr 2025. 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 Egypt. 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?

Evaluate the relation of CRP/ albumin ratio to the prediction of postoperative SIRS or sepsis in polytrauma patients. (time frame: The patients will be evaluated for 5 days postoperatively). 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 NCT06050759, which also lists 9 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 2 Apr 2025.

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