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临床试验/NCT04718623
NCT04718623Unknown不适用

Evaluation of Presepsin and Syndecan-1 as Biomarkers for Early Diagnosis and Prognosis of Sepsis Following Major Surgeries

Alexandria University0 个研究点目标入组 30 人开始时间: 2021年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
Evaluate Presepsin (sCD-14) and Syndecan-1 as biomarkers following major surgeries for early diagnosis and prognosis of sepsis

研究概览

简要总结

The aim of the present work is to study: Persepsin (sCD-14) and Syndecan-1 as biomarkers following major surgeries for early diagnosis and prognosis of sepsis Primary aim: early diagnosis and prognosis of sepsis Secondary aim: correlate them with SOFA and qSOFA scores.

详细描述

Millions of patients die around the world every year because of sepsis. 1%-2% of patients admitted to hospital and 25% of Intensive Care Units (ICU) patients suffer from sepsis. One of the most important principles of sepsis management is early diagnosis and treatment as Surviving Sepsis Campaign recommends Hour-1 bundle use.

Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection and organ dysfunction can be identified as an acute change in total Sepsis related Organ Failure Assessment (SOFA) score ≥ 2 points consequent to the infection.

The baseline SOFA score can be zero in patients not known to have pre-existing organ dysfunction. A SOFA score 2 reflects an overall mortality risk of approximately 10% in a general hospital population with suspected infection. Patients with suspected infection who are likely to have a prolonged ICU stay or die in the hospital can be promptly identified at the bedside with quick SOFA score (qSOFA) i.e. (HAT ie, Hypotension with systolic blood pressure ≤100 mm Hg, Alteration in mental status, or Tachypnea with respiratory rate ≥22/min.

Septic shock is a subset of sepsis in which underlying circulatory and cellular/metabolic abnormalities are profound enough to substantially increase mortality. Patients with septic shock can be identified with a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain mean arterial blood pressure (MAP) ≥65 mm Hg and having a serum lactate level >2 mmol/L (18 mg/dL) despite adequate volume resuscitation. With these criteria, hospital mortality is in excess of 40%.

As blood culture is needed to confirm diagnosis of sepsis it requires 48-72 hours to be performed, and positive rate is low. No single clinical or biological marker indicative of sepsis has been approved.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients aged ≥18 years, of either sex, after full recovery from anaesthesia and extubated, following scheduled major abdominal, abdomino-pelvic or vascular surgeries who develop an evident source of infection whether clinical, laboratory manifestation or radiological signs of infection and/or criteria of quick SOFA (qSOFA) after admission to ICU will be included in the study.

排除标准

  • Patients aged <18 years old.
  • Patients with terminal stage of malignancy of any type.
  • Immune-compromised patients e.g., on immune-suppressive therapy, acquired immunodeficiency syndrome
  • Patients with end-stage liver or renal disease.
  • Patients with existing infection before surgery.
  • Patients with emergency surgeries.
  • Chronic inflammatory disorders e.g., sarcoidosis

结局指标

主要结局

Evaluate Presepsin (sCD-14) and Syndecan-1 as biomarkers following major surgeries for early diagnosis and prognosis of sepsis

时间窗: baseline

measure quantitative concentrations of Persepsin (sCD-14) and Syndecan-1 as biomarkers for early diagnosis and predict outcome

次要结局

  • correlate Persepsin (sCD-14) and Syndecan-1 with SOFA and qSOFA scores.(baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

hossam abousamra

specialist of anaesthesia and intensive care

Alexandria University

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