- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03724188
Impact of Parathyroidectomy on Vascular Calcification and Clinical Outcome in Hemodialysis Patients
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Mansourah, Egypt
- Faculty of Medicine - Mansoura University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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?
Design Details
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
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)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MD/17.11.133
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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