Hyperparathyroidism, SecondaryNCT03724188
Impact of Parathyroidectomy on Vascular Calcification and Clinical Outcome in Hemodialysis Patients
An observational study of Hyperparathyroidism, Secondary, run by Mansoura General Hospital at 1 site in Egypt.
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) Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperparathyroidism, Secondary
- What is being tested?
- surgical parathyroidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 55 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Nov 2017to 30 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients above the age of 18, with ESRD maintained on regular hemodialysis and are indicated for surgical parathyroidectomy
Who may be able to join
- All patients above the age of 18
- patients with End stage renal disease maintained on regular hemodialysis
- indicated for surgical parathyroidectomy
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
Read the 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.
- Conditions
- Hyperparathyroidism, Secondary
- Being tested
- surgical parathyroidectomy
- Medical subject headings
- Hyperparathyroidism, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical parathyroidectomyProcedure or surgery
total parathyroidectomy, subtotal parathyroidectomy, total parathyroidectomy with autotransplantation
| Study group | Role | What they receive |
|---|---|---|
| parathyroidectomy group | the parathyroidectomy group includes 40 hemodialysis patients suffering from sever secondary hyperparathyroidism undergoing surgical parathyroidectomy Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
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)
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start30 Nov 2017
- Primary completion30 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperparathyroidism, SecondaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadia Mohsen Abdu Ibrahim, Mansoura General Hospital
- Investigators
- Tarek M Abbas, PhD, Study chair, Institutional Research Board MFMAhmed M Halawa, PhD, Study chair, Institutional Research Board MFM. Donia M Sobh, Study director, Institutional Research Board MFMNagy S Abd-elhady, PhD, Study chair, Institutional Research Board MFM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724188
- Sponsor's protocol ID
- MD/17.11.133
- Status last verified
- Jun 2024
- First submitted
- 24 Oct 2018
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data collection is not yet complete, study is still ongoing for upgrading and expansion
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Parathyroidectomy on Vascular Calcification and Clinical Outcome in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT03724188
- Acronym / sponsor ID
- MD/17.11.133
- Conditions
- Hyperparathyroidism, Secondary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Mansoura General HospitalUniversity, hospital or other
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 30 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| parathyroidectomy group | – | Procedure: surgical parathyroidectomythe parathyroidectomy group includes 40 hemodialysis patients suffering from sever secondary hyperparathyroidism undergoing 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients above the age of 18, with ESRD maintained on regular hemodialysis and are indicated for surgical parathyroidectomy
Key inclusion criteria (3 listed)
- All patients above the age of 18
- patients with End stage renal disease maintained on regular hemodialysis
- indicated for surgical parathyroidectomy
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical parathyroidectomytotal parathyroidectomy, subtotal parathyroidectomy, total parathyroidectomy with autotransplantation | Procedure or surgery | parathyroidectomy group |
Primary outcome
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
3 secondary outcomes
Emergent Adverse events on laboratory parameters
Time frame: 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 clinical status of the patient
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Individual participant dataSharing planned: No. data collection is not yet complete, study is still ongoing for upgrading and expansion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarek M Abbas, PhD study chair
Institutional Research Board MFM
Ahmed M Halawa, PhD study chair
Institutional Research Board MFM
. Donia M Sobh study director
Institutional Research Board MFM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperparathyroidism, Secondary, run by Mansoura General Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
emergent adverse postoperative events and assessment of the degree of vascular calcification (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.