Impact of Parathyroidectomy on Vascular Calcification and Clinical Outcome in Hemodialysis Patients
NCT ID: NCT03724188
Last Updated: 2024-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
55 participants
OBSERVATIONAL
2017-11-30
2021-10-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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parathyroidectomy group
the parathyroidectomy group includes 40 hemodialysis patients suffering from sever secondary hyperparathyroidism undergoing surgical parathyroidectomy
surgical parathyroidectomy
total parathyroidectomy, subtotal parathyroidectomy, total parathyroidectomy with autotransplantation
non parathyroidectomy group
15 hemodialysis patients with sever secondary hyperparathyroidism who were indicated for surgical parathyroidectomy but did not underwent surgery and continued on medical treatment
No interventions assigned to this group
Interventions
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surgical parathyroidectomy
total parathyroidectomy, subtotal parathyroidectomy, total parathyroidectomy with autotransplantation
Eligibility Criteria
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Inclusion Criteria
* patients with End stage renal disease maintained on regular hemodialysis
* indicated for surgical parathyroidectomy
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
Yes
Sponsors
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Mansoura General Hospital
OTHER
Responsible Party
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Nadia Mohsen Abdu Ibrahim
consultant of nephrology
Principal Investigators
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Tarek M Abbas, PhD
Role: STUDY_CHAIR
Institutional Research Board MFM
Ahmed M Halawa, PhD
Role: STUDY_CHAIR
Institutional Research Board MFM
. Donia M Sobh
Role: STUDY_DIRECTOR
Institutional Research Board MFM
Nagy S Abd-elhady, PhD
Role: STUDY_CHAIR
Institutional Research Board MFM
Locations
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Faculty of medicine - Mansoura university
Al Mansurah, , Egypt
Countries
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Other Identifiers
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MD/17.11.133
Identifier Type: -
Identifier Source: org_study_id
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