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临床试验/NCT06487728
NCT06487728Enrolling By Invitation不适用

The Validity of Urinary Titin and Skeletal Muscle Index as Predictor of Muscle Weakness in Critically Ill Patients. A Prospective Cohort Study

Zagazig University1 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
161
试验地点
1
主要终点
The relationship between cumulative urinary titin level and rate of rectus femoris muscle atrophy on days 1 and 7 of ICU admission

研究概览

简要总结

Although skeletal muscle atrophy is common in critically ill patients, biomarkers associated with muscle atrophy have not been identified reliably. Titin is a spring-like protein found in muscles and has become a measurable biomarker for muscle breakdown and intensive care unit-acquired weakness in critically ill patients, in whom titin loss is a possible pathophysiology. The skeletal muscle index (SMI) is an alternative biomarker for muscle weakness, which is calculated by dividing the cross-sectional area (cm2) of the skeletal muscle at the level of the third lumbar vertebra by the square of the patient's height (m2) on CT The possibility of using urinary titin and skeletal muscle index for early prediction of muscle weakness in critically ill patients.

详细描述

All patients will be subjected to the following:

Informed consent will be obtained from patients. History taking including age, sex, comorbidities, current medications, ethnicity, reason for admission, and body mass index (BMI). General clinical examination. General laboratory investigations: (CBC, Random blood sugar, CRP, ESR).

Urinary Titin Measurement:

The first urine sample will be collected using a urethral catheter within 12 h of ICU admission and 24-hour urine samples d 24-hour urine samples on days 2, 3, 5, and 7.

Urinary titin will be measured using an ELISA kit (Maruyama et al., 2016).

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

  • Consent from relatives of first degree. Consecutive adult patients who will be expected to remain in ICU for >5 days will be enrolled. Nonsurgical critically ill patients will be included because surgical insult reportedly increased urinary titin level (Tanihata et al., 2019). Age more than 18 years. Both male and female.

排除标准

  • Surgery not including percutaneous abscess drainage. Patients with expected prehospital functional status of <48 hours. Chest tube insertion, and tracheostomy in ICU. 8 Current pregnancy. Diagnosis of primary neuromuscular disease. Trauma at the measurement point.

结局指标

主要结局

The relationship between cumulative urinary titin level and rate of rectus femoris muscle atrophy on days 1 and 7 of ICU admission

时间窗: At day 1 and 7 day of icu admission

Measurement of urinary titin level and its correlation to muscle index

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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