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

NCT ID: NCT03724188

Last Updated: 2024-06-25

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-30

Study Completion Date

2021-10-30

Brief Summary

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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

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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.

Conditions

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Hyperparathyroidism, Secondary

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nadia Mohsen Abdu Ibrahim

consultant of nephrology

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Egypt

Other Identifiers

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MD/17.11.133

Identifier Type: -

Identifier Source: org_study_id

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