跳至主要内容
临床试验/NCT03724188
NCT03724188已完成不适用

Impact of Parathyroidectomy on Vascular Calcification and Clinical Outcome in Hemodialysis Patients

Mansoura General Hospital1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2017年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
55
试验地点
1
主要终点
emergent adverse postoperative events and assessment of the degree of vascular calcification

研究概览

简要总结

The aim of this study is to assess the clinical, laboratory and vascular calcification outcome within 6 months duration in patients undergoing surgical parathyroidectomy (total, subtotal, and total with autotransplantation)

详细描述

All patients above the age of 18, with end stage renal disease maintained on regular hemodialysis and are indicated for surgical parathyroidectomy.

The indications for parathyroidectomy included persistently elevated intact parathormone hormone levels of greater than 500 pg/mL, uncontrolled hypercalcaemia with hyperphosphataemia or clinical symptoms of secondary hyperparathyroidism refractory to medical treatment. These symptoms included bone pain, pruritus, fracture, fatigue and calciphylaxis

These patients will be exposed to pre-operative evaluation of clinical, laboratory and vascular calcification in abdominal aorta and coronary calcium scoring using ECG- gated non contrast CT in hemodialysis patients undergoing parathyroidectomy

Post-operative evaluation of clinical, laboratory and vascular calcification in abdominal aorta and coronary calcium scoring using non contrast CT will be done 6 months post-operative

Assessment of the relation between preoperative and postoperative measures

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients above the age of 18
  • patients with End stage renal disease maintained on regular hemodialysis
  • indicated for surgical parathyroidectomy

排除标准

  • Chronic kidney disease patients not yet on regular Hemodialysis
  • patients who had primary hyperparathyroidism
  • patients who had received kidney transplantation
  • patients who underwent repeated parathyroidectomy
  • patients who were lost to follow-up or with missing data.

结局指标

主要结局

emergent adverse postoperative events and assessment of the degree of vascular calcification

时间窗: 6 months

assessment of emergent adverse postoperative events as bleeding, indication for mechanical ventilation and intensive care unit admission, vocal cord injury and development of hypoparathyroidism with persistent hypocalcemia assessment of degree of vascular calcification via measuring calcium scoring through ECG gated non contrast CT

次要结局

  • Emergent Adverse events on clinical status of the patient(6 months)
  • Emergent Adverse events on laboratory parameters(6 months)
  • Emergent Adverse events on Quality of life through assessing physical functioning, limitations due to physical health, limitations due to emotional problems, Energy/Fatigue, Emotional wellbeing, Social functioning, Pain, and General health(6 months)

研究者

发起方
Mansoura General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nadia Mohsen Abdu Ibrahim

consultant of nephrology

Mansoura General Hospital

研究点 (1)

Loading locations...

相似试验