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

Sponsor
Ain Shams University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06050759
Collaborator
(none)
100
15

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: CRP and Albumin level in blood sample

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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Outcome Measures

Primary Outcome Measures

  1. 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.

Secondary Outcome Measures

  1. 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]

    evaluate the relation of CRP / albumin ratio to the occurrence of postoperative infection as surgical site infection or pulmonary infection .

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 INR> 2.2 ) (Tsoris , et al.,2023) or liver cell failure.

  • Patients receiving Albumin Supplementation during the period of the study.

  • Age < 18y.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ain Shams University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ahmed Samir Said Salem, Assistant Lecturer of Anaesthesia and Intensive care, Ain Shams University
ClinicalTrials.gov Identifier:
NCT06050759
Other Study ID Numbers:
  • MD134/2023
First Posted:
Sep 22, 2023
Last Update Posted:
Sep 22, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ahmed Samir Said Salem, Assistant Lecturer of Anaesthesia and Intensive care, Ain Shams University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 22, 2023