Clinical trial NCT03724188: Impact of Parathyroidectomy on Vascular Calcification and Clinical Outcome in Hemodialysis Patients
Official title: Impact of Parathyroidectomy on Vascular Calcification and Clinical Outcome in Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperparathyroidism, Secondary
Lead sponsor: Mansoura General Hospital
Sponsor class: OTHER
First posted: 2018-10-30
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients above the age of 18, with ESRD maintained on regular hemodialysis and are indicated for surgical parathyroidectomy

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.

Eligibility criteria: 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.

Primary outcomes:
measure: emergent adverse postoperative events and assessment of the degree of vascular calcification
timeFrame: 6 months
Secondary outcomes:
measure: Emergent Adverse events on laboratory parameters
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: Emergent Adverse events on clinical status of the patient
timeFrame: 6 months
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Faculty of medicine - Mansoura university
Study officials:
affiliation: Institutional Research Board MFM
name: Tarek M Abbas, PhD
role: STUDY_CHAIR
affiliation: Institutional Research Board MFM
name: Ahmed M Halawa, PhD
role: STUDY_CHAIR
affiliation: Institutional Research Board MFM
name: . Donia M Sobh
role: STUDY_DIRECTOR
affiliation: Institutional Research Board MFM
name: Nagy S Abd-elhady, PhD
role: STUDY_CHAIR
References: