跳至主要内容
临床试验/CTRI/2025/08/093279
CTRI/2025/08/093279尚未招募不适用

Assessment of Magnitude of Sarcopenia among Adult Patients with Liver Cirrhosis and Its Impact on Predicted Twelve-Month Mortality at a Tertiary Health Care Centre of North India

GSVM MEDICAL COLLEGE KANPUR1 个研究点 分布在 1 个国家目标入组 402 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
402
试验地点
1
主要终点
Burden of sarcopenia among patients with liver cirrhosis

研究概览

简要总结

Cirrhosis is a chronic and irreversible liver disease, characterized by fibrosis and nodular regeneration, which often leads to complications such as ascites, hepatic encephalopathy, and variceal bleeding. In India, the burden of cirrhosis is on the rise, primarily due to hepatitis B and C infections, alcohol misuse, and metabolic-associated steatotic liver disease (MASLD) . These complications significantly reduce survival, with the five-year mortality rate ranging between 20% and 30%. Sarcopenia is defined as a progressive and generalized loss of skeletal muscle mass and strength.  However, awareness regarding sarcopenia remains low among clinicians. In the Indian context, the under diagnosis is further aggravated by limited availability of diagnostic tools such as DEXA scan, Bioelectrical Impedance Analysis (BIA), CT, and MRI . As a result, opportunities for early diagnosis and intervention are often missed, leading to increased morbidity and mortality, prolonged hospitalization, and higher healthcare costs.

It is estimated that sarcopenia affects 45% to 70% of patients with cirrhosis in the South-East Asian region. In such patients, sarcopenia independently contributes to a two- to three-fold increase in mortality. While it is typically associated with ageing and commonly observed in individuals above 60 years of age, sarcopenia tends to appear much earlier in patients with chronic liver disease (CLD). This early onset is attributed to the catabolic and inflammatory environment caused by hepatic dysfunction, including hyperammonaemia, hormonal imbalances, malnutrition, and physical inactivity. Consequently, there is an increased risk of mortality even at a younger age.

Currently, prognostic models such as the Child-Pugh score are widely used to predict short-term mortality in patients with cirrhosis. However, these models may not adequately reflect the impact of sarcopenia . There is a paucity of Indian data regarding the prevalence of sarcopenia and its prognostic implications in liver cirrhosis. Addressing this gap is crucial, particularly in tertiary care centres where patient load is high.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Age more than or equal to 18 years Ready to participate in the study as per protocol (Consenting) Confirmed diagnosis of liver cirrhosis based on Clinical criteria as Ascites with SAAG ratio equal to or greater than 1.1 presence of esophageal varices past history of hepatic encephalopathy supported by treatment documents Biochemical test Serum Albumin equal to or less than 3.5 mg percent INR greater than 1.3 Imaging Nodular liver architecture seen on ultrasound splenomegaly collateral circulation portal vein size greater 13 mm Alcohol abstinence equal to or greater than 3 months Hemoglobin level equal to or greater than 8 g per dl Stable subjects with co-morbidities like diabetes with HbA1c less than 10 percent hypertension with BP less than SBP 140 and DBP less than 90 mm Hg hypothyroidism or hyperthyroidism with normal thyroid function on appropriate therapy CKD stage 1& 2 will be eligible for participation.
  • They should be on stable dose for last at least three months.

排除标准

  • Acute hepatic decompensation Jaundice History of hospitalization in last three months Malignancy CKD (stage equal to or greater than 3) Heart Failure (NYHA III and IV) COPD GOLD Stage III & IV Neuromuscular disease (such as myasthenia gravis) Stroke or other neurologic disorder with residual deficit Infections like HIV active pulmonary or extrapulmonary TB Critical illness Organ transplant or immunosuppression Pregnancy and lactation Long-term steroid use (except inhaled or topical) Bedridden subjects due to their inability in performing the required tests Subjects having locomotor abnormalities.

结局指标

主要结局

Burden of sarcopenia among patients with liver cirrhosis

时间窗: Baseline

次要结局

  • impact of Sarcopenia among patients with Liver cirrhosis on predicted twelve-month mortality at a tertiary care center of North India(Assessment of quality of life using SARQOL)

研究者

发起方
GSVM MEDICAL COLLEGE KANPUR
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Saurabh Agarwal

GSVM Medical College

研究点 (1)

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