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

NCT03724188 | Completed

• 1 other identifier: MD/17.11.133
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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)

Conditions

Hyperparathyroidism, Secondary

Outcome Measures

Primary Outcomes (1)

• emergent adverse postoperative events and assessment of the degree of vascular calcification

  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

  6 months

Secondary Outcomes (3)

• Emergent Adverse events on laboratory parameters

  6 months

• 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 clinical status of the patient

  6 months

Study Arms (2)

parathyroidectomy group

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

Procedure: surgical parathyroidectomy

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

Interventions

surgical parathyroidectomy PROCEDURE

total parathyroidectomy, subtotal parathyroidectomy, total parathyroidectomy with autotransplantation

parathyroidectomy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• All patients above the age of 18
• patients with End stage renal disease maintained on regular hemodialysis
• indicated for surgical parathyroidectomy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura General Hospital: lead

Study Sites (1)

Faculty of medicine - Mansoura university

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Study Officials

• Tarek M Abbas, PhD

  Institutional Research Board MFM

  STUDY CHAIR

• Ahmed M Halawa, PhD

  Institutional Research Board MFM

  STUDY CHAIR

• . Donia M Sobh

  Institutional Research Board MFM

  STUDY DIRECTOR

• Nagy S Abd-elhady, PhD

  Institutional Research Board MFM

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: consultant of nephrology

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: October 30, 2018
• Study Start: November 30, 2017
• Primary Completion: October 30, 2021
• Study Completion: October 30, 2021
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)