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

Hyperparathyroidism Tertiary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03724188
• Other study ID #: MD/17.11.133
• Status: Completed
• Start date: November 30, 2017
• Est. completion date: October 30, 2021

Study information

• Verified date: March 2023
• Source: Mansoura General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism Tertiary
• Vascular Calcification

Intervention

Procedure:
• surgical parathyroidectomy
total parathyroidectomy, subtotal parathyroidectomy, total parathyroidectomy with autotransplantation

Locations

Country	Name	City	State
Egypt	Faculty of medicine - Mansoura university	Mansourah

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura General Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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