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

Completed

• Conditions: Crp

• Registration Number: NCT06050759
• Lead Sponsor: Ain Shams University

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.

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 Timeline

• Study First Submitted: 2023-09-16
• Study First Submitted QC: 2023-09-21
• Study First Posted: 2023-09-22
• Study Start: 2023-12-01
• Primary Completion: 2024-11-01
• Study Completion: 2024-12-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

AinShams University Specialized Hospital; 🇪🇬 Cairo, Abbasia, Egypt