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

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)

Study Overview

• Status: Completed
• Conditions: Hyperparathyroidism, Secondary
• Intervention / Treatment: Procedure: surgical parathyroidectomy

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 Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• Egypt
  • Mansourah, Egypt
    • Faculty of Medicine - Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
parathyroidectomy group; the parathyroidectomy group includes 40 hemodialysis patients suffering from sever secondary hyperparathyroidism undergoing surgical parathyroidectomy	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mansoura General Hospital
• Investigators: Study Chair: Tarek M Abbas, PhD, Institutional Research Board MFM; Study Chair: Ahmed M Halawa, PhD, Institutional Research Board MFM; Study Director: . Donia M Sobh, Institutional Research Board MFM; Study Chair: Nagy S Abd-elhady, PhD, Institutional Research Board MFM

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2017
• Primary Completion (Actual): October 30, 2021
• Study Completion (Actual): October 30, 2021

Study Registration Dates

• First Submitted: October 24, 2018
• First Submitted That Met QC Criteria: October 29, 2018
• First Posted (Actual): October 30, 2018

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 21, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Endocrine System Diseases; Parathyroid Diseases; Calcium Metabolism Disorders; Calcinosis; Hyperparathyroidism; Hyperparathyroidism, Secondary; Vascular Calcification
• Other Study ID Numbers: MD/17.11.133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: data collection is not yet complete, study is still ongoing for upgrading and expansion

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No