跳至主要内容
临床试验/NCT04554628
NCT04554628已完成不适用

Early Prediction of Acute Kidney Injury Among Patients Admitted to Surgical ICU

Tanta University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年9月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
2
主要终点
The ability of estimated urinary markers for prediction of patients susceptible to develop AKI.

研究概览

简要总结

Early prediction of AKI can help to improve patients' outcome through early institution of the appropriate intervention, thus the current study hypothesizes that urine analysis for certain markers may provide an early knowledge about the possibility of oncoming kidney affection secondary to organ and tissue trauma affecting patients admitted to surgical ICU.

The current study tries to evaluate the value of urinary markers as early predictors of possible development of AKI in patients admitted to surgical ICU.

详细描述

All patients will be clinically evaluated for demographic and clinical data. Severity of injury and number of surgical interventions will be evaluated using the simplified Therapeutic Intervention Scoring System (TISS-28) and the extent of impact of associated diseases on patients' physiological and body organs' functions will be evaluated using the Acute Physiology and Chronic Health Evaluation (APACHE II) and sequential organ failure assessment (SOFA) . Higher scores indicate more severe illness and for the TISS-28 score, each therapeutic intervention will be assigned 1 to 4 points, and the points will be summed daily to obtain the overall score and higher score indicates a higher number of therapeutic interventions.

Diagnosis of AKI Development of AKI within the first 48 hours after ICU admission and its staging will be defined according to the Acute Kidney Injury Network criteria. Each stage will be defined by the extent of change in serum creatinine level (∆SCr) as follows: Mild if Scr was increased by ≥0.3 mg/ml or ∆SCr was ≥1.5-2-fold from baseline, Moderate if ∆SCr was >2-3-fold from baseline and Severe if ∆SCr was increase by >3-fold from baseline .

Laboratory investigations Blood samples will be sent for estimation of serum creatinine (SCr) . Urine samples will be sent for spot creatinine , UNGAL, KIM1.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Diagnostic
盲法
Single (Participant)

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

  • All patients who were admitted to surgical ICU will be eligible for evaluation for inclusion and exclusion criteria.

排除标准

  • Patients with manifest kidney disease.
  • Patients had renal surgery
  • Patients maintained on renal replacement therapy
  • Patients had diabetic nephropathy.
  • Patients had liver disease, endocrinopathies.
  • Patients morbid obesity that was defined as body mass index (BMI) >35 kg/m2 .

结局指标

主要结局

The ability of estimated urinary markers for prediction of patients susceptible to develop AKI.

时间窗: 180 days

The ability of UNGAL and UKIM1 to early predict acute kidney injury before the serum creatinine rises.

次要结局

  • The number of patients who developed rise of Serum Creatinine diagnostic of AKI and the extent of AKI severity(180days)
  • The best detector of acute kidney injury(180 days)

研究者

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

MOHAMMED FAWZI ALI ABOSAMAK

lecturer of anesthesia and intensive care

Tanta University

研究点 (2)

Loading locations...

相似试验