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Completed

NCT Number: NCT06050759

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AinShams University Specialized Hospital

Cairo, Abbasia, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CRP and Albumin level in blood sample

Diagnostic Test

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 22, 2023
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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