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

Completed

• Conditions: Hyperparathyroidism, Secondary
• Interventions: Procedure: surgical parathyroidectomy

• Registration Number: NCT03724188
• Lead Sponsor: Mansoura General Hospital

Brief Summary

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)

Detailed 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.

Study Timeline

• Study Start: 2017-11-30
• Study First Submitted: 2018-10-24
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-30
• Primary Completion: 2021-10-30
• Study Completion: 2021-10-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
parathyroidectomy group	surgical parathyroidectomy	the parathyroidectomy group includes 40 hemodialysis patients suffering from sever secondary hyperparathyroidism undergoing surgical parathyroidectomy

Primary Outcome Measures

Name	Time	Method
emergent adverse postoperative events and assessment of the degree of vascular calcification	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 Outcome Measures

Name	Time	Method
Emergent Adverse events on clinical status of the patient	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
Emergent Adverse events on laboratory parameters	6 months	assessment of s.calcium in mg/dl s.phosphorus ( mg/dl) and level of intact parathormone hormone in ( pg/mL)
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	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

Trial Locations

Locations (1)

Faculty of medicine - Mansoura university; 🇪🇬 Mansourah, Egypt