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Completed

NCT Number: NCT03724188

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

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)

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Key information

Conditions

Hyperparathyroidism, Secondary Endocrine System Diseases Hyperparathyroidism Parathyroid Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of medicine - Mansoura university

Al Mansurah, Egypt

About this study

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:

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

surgical parathyroidectomy

Procedure

total parathyroidectomy, subtotal parathyroidectomy, total parathyroidectomy with autotransplantation

Primary outcomes

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

    Time frame: 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

Secondary outcomes

  1. Emergent Adverse events on laboratory parameters

    Time frame: 6 months

    assessment of s.calcium in mg/dl s.phosphorus ( mg/dl) and level of intact parathormone hormone in ( pg/mL)

  2. 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

    Time frame: 6 months

    Emergent Adverse events on Quality of life using short form 36 heath survey questionaire to assess physical functioning, limitations due to physical health, limitations due to emotional problems, Energy/Fatigue, Emotional wellbeing, Social functioning, Pain, General health

  3. Emergent Adverse events on clinical status of the patient

    Time frame: 6 months

    improvement of clinical symptoms related to hyperparathyroidism prior to surgery, occurrence of surgical complications related to parathyroidectomy procedure, cardiovascular problems, bone aches and disabilities, pruritis

Sponsors and collaborators

Lead sponsor

Mansoura General Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Oct 30, 2018
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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