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临床试验/CTRI/2024/09/073770
CTRI/2024/09/073770
尚未招募
不适用

To study prevalence of Sarcopenia in a patients with decompensated liver cirrhosis in tertiary care hospital

Datta Meghe Institute of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2024年9月19日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
Datta Meghe Institute of Higher Education and Research
入组人数
97
试验地点
1
主要终点
To study prevalence of sarcopenia in a patients with cirrhosis of liver

概览

简要总结

The study will be conducted only after a clearance is obtained from the local ethical committee of Datta Meghe Institute of Medical Sciences, Sawangi (M), Wardha by submitting a synopsis mentioning all the proposed study details and protocols.

It is Observational Prospective Study

The study will be conducted in Acharya Vinoba Bhave rural Hospital (AVBRH), a tertiary care teaching hospital situated in the rural area of Wardha District. The aforementioned hospital, AVBRH, is a 1500+ bedded teaching hospital providing healthcare to the rural people of central India. Detailed history and physical examination will be performed.

Below tests are done for sarcopenia.

CT scan will be done to look for skeletal muscle index at 3rd lumbar vertebrae.

It is the only modality that has validated sex- specific cut-offs, notably <50 cm2/m2 in men and <39 cm2/m2 in women.

Mid-arm muscle circumference (MAMC): MAMC (in cm) is obtained by measuring the mid-arm circumference (MAC; in cm) and tricep skinfold (TSF; in mm). These measures are cheap, quick and can be safely used in routine clinical practice to assess repeated measures of sarcopenia.

Muscle strength :The most frequently used modality is hand grip strength

(HGS) as it is simple and can be used for repeated measures.

It is recommended by the recent European guidelines in the assessment of patients with cirrhosis. HGS has been shown to be

a better predictor of adverse clinical outcomes than CT measures of muscle mass and model for end-stage liver disease (MELD).

Muscle function :Short Physical Performance Battery (SPPB) consists of chair stands, gait speed and balance (each scored out of 4; with a maximal score of 12) and a score <10 increases the odds of mortality by 2.5

 Liver Frailty Index (LFI):It replaces gait speed with HGS and is sub-categorised into frail (>4.4), pre-frail (3.2 - 4.4) and robust (<3.2).

Aerobic exercise capacity:This relies on muscle function, and can be assessed using the easy-to-apply, objective 6-minute walk distance (6MWD) or the more expensive, time-consuming cardiopulmonary exercise test (CPET).A 6MWD of less than 250 m represents poor muscle function/exercise capacity and is associated with two-fold increased mortality in patients on the transplant waiting list.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients visiting (OPD/IPD) in AVBRH having a diagnosis of cirrhosis of liver will be included in this study.
  • The diagnosis of Sarcopenia in liver cirrhosis is by various definitions of sarcopenia .

排除标准

  • 未提供

结局指标

主要结局

To study prevalence of sarcopenia in a patients with cirrhosis of liver

时间窗: At baseline

次要结局

未报告次要终点

研究者

发起方
Datta Meghe Institute of Higher Education and Research
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Virendra Bhad

Datta Meghe Institute Of Higher Education and Research

研究点 (1)

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