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临床试验/CTRI/2025/01/079288
CTRI/2025/01/079288
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Assessment of Quadriceps Muscle Layer Thickness trajectory and its association with Preadmission Frailty, comorbidities, and Mortality in Critically Ill Patients aged more than 50 years admitted in the ICU: A Prospective observational study.

Father Muller Medical College1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月5日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
Father Muller Medical College
入组人数
40
试验地点
1
主要终点
Association of the change in QMLT from baseline to day 4, day 7, and at hospital discharge with frailty, co-morbidities, and mortality in critically ill patients aged over 50 years admitted to the ICU.

概览

简要总结

This prospective, single-center observational study aims to evaluate the trajectory of Quadriceps Muscle Layer Thickness (QMLT) during the first week of ICU admission and its association with preadmission frailty, comorbidities, and mortality in critically ill patients aged over 50 years. Frailty, assessed using the Clinical Frailty Scale (CFS), is a known predictor of poor outcomes in ICU patients. Sarcopenia, closely linked to frailty, further compounds vulnerability and impairs recovery.

The study will include 40 patients admitted to the ICU with an expected stay exceeding 96 hours. Baseline QMLT will be measured via bedside ultrasonography on day 1, followed by repeat measurements on days 4, 7, and at hospital discharge. Associations between QMLT changes and clinical frailty, comorbidity-polypharmacy scores, and mortality will be analyzed. Secondary outcomes, including ventilator-free days, vasopressor-free days, renal replacement therapy (RRT) use, ICU/hospital length of stay, and infection rates, will also be evaluated.

This research seeks to identify the utility of QMLT as a dynamic marker of critical illness progression and its relationship with frailty and comorbid conditions. Findings may guide early interventions and tailored care strategies for critically ill adults, enhancing outcomes and resource optimization in ICUs.

研究设计

研究类型
Observational

入排标准

年龄范围
50.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients aged more than 50 years.
  • Admitted to the ICU.
  • Expected ICU stay of more than 96 hours.

排除标准

  • Patients who are pregnant.
  • Patients anticipated to have a poor prognosis or who choose to discontinue life-sustaining treatment.
  • Patients with amputated or injured lower limbs.
  • Patients with bilateral deep vein thrombosis.
  • Patients who stayed in the hospital for more than 5 days in the past 2 weeks.
  • Patients not ambulating independently before the illness leading to ICU admission (unable to walk more than 15m without stopping, with or without gait aid).
  • Patients with pre-existing primary systemic neuromuscular diseases (acute or chronic presentation).

结局指标

主要结局

Association of the change in QMLT from baseline to day 4, day 7, and at hospital discharge with frailty, co-morbidities, and mortality in critically ill patients aged over 50 years admitted to the ICU.

时间窗: At Baseline, 4th day, 7th day and at hospital discharge

次要结局

  • Association of organ supports & other outcomes (ventilator-free days, vasopressor-free days, Requirement of RRT, RRT-free days, LOS ICU, LOS Hospital) with(a. Changes in QMLT (from baseline to day 4, day 7, & at hospital discharge))

研究者

发起方
Father Muller Medical College
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr VIJAY SUNDARSINGH SUBBIAH

FATHER MULLERS MEDICAL COLLEGE HOSPITAL

研究点 (1)

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