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

M

Mansoura General Hospital

Status

Completed

Conditions

Hyperparathyroidism, Secondary

Treatments

Procedure: surgical parathyroidectomy

Study type

Observational

Funder types

Other

Identifiers

NCT03724188
MD/17.11.133

Details and patient eligibility

About

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)

Full description

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

Patients with the following criteria will be excluded:

  1. chronic kidney disease patients not yet on regular Hemodialysis
  2. patients who had primary hyperparathyroidism
  3. patients who had received kidney transplantation
  4. patients who underwent repeated parathyroidectomy
  5. patients who were lost to follow-up or with missing data.

Enrollment

55 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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.

Trial design

55 participants in 2 patient groups

parathyroidectomy group
Description:
the parathyroidectomy group includes 40 hemodialysis patients suffering from sever secondary hyperparathyroidism undergoing surgical parathyroidectomy
Treatment:
Procedure: surgical parathyroidectomy
non parathyroidectomy group
Description:
15 hemodialysis patients with sever secondary hyperparathyroidism who were indicated for surgical parathyroidectomy but did not underwent surgery and continued on medical treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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