Pruritus and Pemphigoid in Nursing Home Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Detection of circulating pemphigoid specific IgG autoantibodies by indirect immunofluorescence microscopy on monkey esophagus substrate
研究概览
简要总结
The primary objective of this observational study is to describe the prevalence of pruritus and pemphigoid in nursing home patients. Secondary outcomes are the relationships of demographic factors and medical risk factors with pemphigoid, including dementia and neuropsychiatric symptoms, medication use and Karnofsky score.
详细描述
Pruritus or itch is the most common skin symptom in elderly patients and is estimated to affect more than 30% of nursing home patients. Clinical and experimental evidence suggests pruritus in elderly patients may be linked to pemphigoid. Pemphigoid is the most common autoimmune skin blistering diseases and mainly affects the elderly. It is successfully treatable with systemic therapy. However, pemphigoid is often missed as a cause of pruritus in elderly patients (nonbullous cutaneous pemphigoid). Although nursing home patients and patients with dementia in particular have the highest risk for development of pemphigoid, no study has been performed in this population so far. Including serological screening for pemphigoid in the diagnostic evaluation of chronic pruritus in nursing home patients may lead to the diagnosis of pemphigoid. Furthermore, chronic itch may be an unrecognized cause of neuropsychiatric symptoms in nursing home patients with dementia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatient of a nursing home
- •Age 65 years or above
- •Subject or their official representatives have signed informed consent
排除标准
- •Age below 65 years
- •Subjects who do not have signed informed consent
- •Receiving treatment with any systemic immunosuppressive agents
- •Terminally ill patients with a life expectancy of less than 4 weeks
结局指标
主要结局
Detection of circulating pemphigoid specific IgG autoantibodies by indirect immunofluorescence microscopy on monkey esophagus substrate
时间窗: Day 1
Anti-basement membrane zone IgG autoantibodies; positive/negative, staining intensity IgG 1+,2+,3+
Detection of circulating pemphigoid specific IgG autoantibodies by immunoblot of keratinocyte extract
时间窗: Day 1
Presence/absence of circulating IgG autoantibodies against BP180 (180kDa) or BP230 (230kDa)
Detection of circulating pemphigoid specific IgG autoantibodies by indirect immunofluorescence on 1M salt-split human skin substrate
时间窗: Day 1
IgG autoantibodies with epidermal side staining of artificial split; positive/negative, staining intensity IgG 1+,2+,3+
Concentration of anti-BP230 IgG autoantibodies by ELISA
时间窗: Day 1
Anti-BP230 IgG index; U/mL, cut-off value 9 U/mL
Concentration of anti-BP180 NC16A IgG autoantibodies by ELISA
时间窗: Day 1
Anti-BP180 NC16A IgG index; U/mL, cut-off value 9 U/mL
Presence of pruritus
时间窗: Day 1
Presence and intensity of pruritus will be determined (hetero-)anamnestically with the Bullous Pemphigoid Disease Area Index (BPDAI) VAS score and derivative score for all subjects.
次要结局
- Age(Day 1)
- Sex(Day 1)
- Comorbidities(Day 1)
- Karnofsky Performance Scale(Day 1)
- Medication(Day 1)
- Neuropsychiatric symptoms(Day 1)
研究者
M.F. Jonkman
MD PhD
University Medical Center Groningen