Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03724188
Recruitment Status : Recruiting
First Posted : October 30, 2018
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
Nadia Mohsen Abdu Ibrahim, Mansoura General Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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)

Condition or disease Intervention/treatment
Hyperparathyroidism Tertiary 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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Impact of Parathyroidectomy on Vascular Calcification and Clinical Outcome in Hemodialysis Patients
Actual Study Start Date : November 30, 2017
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
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
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03724188


Contacts
Layout table for location contacts
Contact: Nadia M Ibrahim, master 00201006972379 dr.nadia.m@gmail.com

Locations
Layout table for location information
Egypt
Faculty of medicine - Mansoura university Recruiting
Mansourah, Egypt
Contact: Nadia M Ibrahim, MSc       dr.nadia.m@gmail.com   
Principal Investigator: Nadia M Ibrahim, master         
Sponsors and Collaborators
Mansoura General Hospital
Investigators
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Nadia Mohsen Abdu Ibrahim, specialist of nephrology, Mansoura General Hospital
ClinicalTrials.gov Identifier: NCT03724188    
Other Study ID Numbers: MD/17.11.133
First Posted: October 30, 2018    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: data collection is not yet complete, study is still ongoing for upgrading and expansion

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Vascular Calcification
Hyperparathyroidism
Parathyroid Diseases
Endocrine System Diseases
 Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases