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临床试验/NCT06721845
NCT06721845已完成不适用

Non-Cirrhotic Hyperammonemia Versus Hyperlactatemia in Septic Patients and Impact of Treatment

Menoufia University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年7月1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
60
试验地点
1
主要终点
Serum ammonia specificity and sensitivity in predicting sepsis in comparison to lactate

研究概览

简要总结

Objectives: This study aims to determine the validity of hyperammonemia in predicting true sepsis compared to hyperlactemia in critically ill septic patients.

Background: Sepsis is associated with amino acid flux towards the liver, which increases the ammonia load. The combination of decreased clearance and increased load is thought to be the major cause of increased ammonia in sepsis.

Methodology: 60 septic patients were classified into 2 equal groups, Group I: Septic patients with positive microbial cultures. Group II: septic patients with negative cultures enrolled to obtain serum ammonia and lactic acid levels on admission and every six hours for three days. The primary outcome was to detect ammonia specificity and sensitivity in predicting sepsis in comparison to lactate. The secondary outcomes were need for mechanical ventilation, mortality, and length of stay (LHS) within the intensive care unit.

详细描述

Objectives: The study compares between non-cirrhotic hyperammonemia and hyperlactemia in predicting sepsis in critically ill septic patients.

The septic patients were classified into 2 equal groups, Group I: Septic patients with positive microbial cultures. Group II: septic patients with negative cultures enrolled to obtain serum ammonia and lactic acid levels on admission and every six hours for three days, to detect ammonia specificity and sensitivity in predicting sepsis in comparison to lactate. also, need for mechanical ventilation, mortality, and length of stay (LHS) within the intensive care unit were reported.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
19 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients aged 19-75 years old
  • both sexes with severe sepsis and septic shock
  • within the first 48 hours of ICU admission

排除标准

  • Hepatic patients (cirrhotic, hepatitis),
  • Renal failure, Ureterosigmoidostomy,
  • Malignancy or on Chemotherapy,
  • Pregnancy,
  • Parenteral nutrition,
  • Autoimmune diseases or Immunosuppressive illness, and

结局指标

主要结局

Serum ammonia specificity and sensitivity in predicting sepsis in comparison to lactate

时间窗: up to three days.

Blood samples to obtain Serial ammonia and lactic acid levels

次要结局

未报告次要终点

研究者

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

ashraf magdy eskandr

professor of anesthesia, ICU, Pain Management

Menoufia University

研究点 (1)

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