Ultrasound-Based Sarcopenia Assessment in Pediatric Chronic Liver Disease: Correlation with Clinical Outcomes and Evaluation of a PELD-Sarcopenia Scoring Model
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Correlation of ultrasound-defined sarcopenia with
研究概览
简要总结
While adult studies have consistently shown sarcopenia to be an independent predictor of adverse outcomes, its burden and clinical relevance in pediatric chronic liver disease (pCLD) remain underexplored. The Pediatric End Stage Liver Disease (PELD) score, although widely used for prognostication and transplant prioritization, does not incorporate muscle mass or nutritional reserve, potentially underestimating disease severity in sarcopenic children.
Computed tomography based muscle quantification, the current reference standard, is limited in children due to radiation exposure and feasibility concerns. Ultrasonography offers a safe, radiation-free, bedside modality for assessing muscle mass which is a more apt tool for pediatric age group. Measurement of bilateral anterior thigh thickness (BATT), encompassing rectus femoris and vastus intermedius muscles, has shown good correlation with CT-derived muscle indices in preliminary pediatric studies, but its prognostic utility in pediatric chronic liver disease has not been systematically evaluated.
This prospective observational study aims to assess sarcopenia using ultrasound-derived BATT measurements in children less than or equal to 15 years with chronic liver disease and to examine its association with disease severity and clinical outcomes. Baseline BATT measurements and PELD scores will be obtained at enrollment, with participants followed prospectively for up to three years to record infections, hospital and ICU admissions, and mortality. Correlation and multivariate analyses will be performed to evaluate the independent impact of sarcopenia on outcomes and to explore the development of a composite PELD Sarcopenia score.
This study seeks to establish ultrasound based sarcopenia assessment as a feasible and clinically relevant prognostic tool in pediatric chronic liver disease and to determine whether integrating muscle mass parameters with existing scoring systems improves risk stratification and outcome prediction in this vulnerable population.
研究设计
- 研究类型
- 观察性
入排标准
- 年龄范围
- 1.00 Day(s) 至 15.00 Year(s)(—)
- 性别
- All
入选标准
- Children less than or equal to 15 years of age Diagnosed with pediatric chronic liver disease Informed consent from primary caregiver.
排除标准
- Hemodynamic instability Acute decompensation (overt hepatic encephalopathy, gastrointestinal bleeding).
结局指标
主要结局
Correlation of ultrasound-defined sarcopenia with
时间窗: Continuous follow up at 4 weeks interval with additional time point at visit to hospital due to complications of the disease and new onset infections, requirement of hospital admission and death
PELD score, Infections, Hospital stay including ICU stay, Mortality over 3 year follow-up
时间窗: Continuous follow up at 4 weeks interval with additional time point at visit to hospital due to complications of the disease and new onset infections, requirement of hospital admission and death
次要结局
- Development of a composite PELD-Sarcopenia scoring model(At the time of recruitment)
研究者
Dr Tryambak Samanta
Medical College, Kolkata
研究点 (1)
标识符
- CTRI 编号
- CTRI/2026/02/103633
日期
- 最近更新
- (7个月前)
