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

March 28, 2025 updated by: Ahmed Samir Said Salem, Ain Shams University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Abbasia
      • Cairo, Abbasia, Egypt
        • AinShams University Specialized Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluate the relation of CRP / albumin ratio to the occurrence of postoperative infection as surgical site infection or pulmonary infection .
Time Frame: The patients will be evaluated for 5 days postoperatively
evaluate the relation of CRP / albumin ratio to the occurrence of postoperative infection as surgical site infection or pulmonary infection .
The patients will be evaluated for 5 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Ahmed Samir, Doctor, Faculty of Medicine Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

November 1, 2024

Study Completion (Actual)

December 30, 2024

Study Registration Dates

First Submitted

September 16, 2023

First Submitted That Met QC Criteria

September 21, 2023

First Posted (Actual)

September 22, 2023

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 28, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD134/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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