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Short- and Long-Term Impact of Subtotal Parathyroidectomy on the Achievement of Bone and Mineral Parameters Recommended by Clinical Practice Guidelines in Dialysis Patients

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ClinicalTrials.gov Identifier: NCT01872429
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : June 7, 2013
Sponsor:
Information provided by (Responsible Party):
Far Eastern Memorial Hospital

Brief Summary:
The impact of parathyroidectomy (PTX) on the bone mineral parameters in dialysis patients with secondary hyperparathyroidism (SHPT) remains unclear. The investigators performed this study to present the short- and long-term impact of PTX on calcium, phosphorus and intact parathyroid hormone control in dialysis patients with severe SHPT after operation. In particular, the investigators evaluate the impact based on the achievement of recommendations of the current clinical practice guidelines for bone and mineral parameters in dialysis patients after PTX.

Condition or disease
Hyperparathyroidism

Detailed Description:
  1. A retrospective chart review of dialysis patients including referred cases, receiving surgical PTX, which was performed by one surgeon at the Far Eastern Memorial Hospital, a 1084-bed tertiary-care medical center in northern Taiwan will be performed.
  2. Serum levels of calcium, phosphorus and intact parathyroid hormone were routinely measured for three consecutive post-operative days and subsequent laboratory values were checked during out-patient follow-up period. Patients with postoperative 6-month laboratory data are included in the short-term group and those with more than 6-month available data are in the long-term one.
  3. The National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI™) Clinical Practice Guidelines provided recommended target values for serum intact parathyroid hormone (iPTH)(150-300 pg/ml), phosphorus (3.5-5.5 mg/dl), calcium (8.4-9.5 mg/dl) and the calcium-phosphorus product (<55 mg2/dl2). The Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guidelines suggested maintaining serum calcium in the reference range (8.5-10.5 mg/dl), phosphorus (2.7-4.5 mg/dl) and PTH values in the range of two to nine times the upper reference limit (130 - 585 pg/ml) in dialysis patients.
  4. The investigators evaluated the impact of subtotal PTX on the control of bone and mineral parameters in dialysis patients with secondary HPT as the percentages of cases achieving the recommended K/DOQI and KDIGO targets.

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Study Type : Observational
Actual Enrollment : 401 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : November 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Group/Cohort
Short-term group
Patients with postoperative 6-month laboratory data were included in the short-term group
Long-term group
Patients with postoperative more than 6-month laboratory data were included in the long-term group



Primary Outcome Measures :
  1. The percentages of cases achieving the recommended K/DOQI and KDIGO targets for bone mineral parameters after subtotal PTx [ Time Frame: Twelve year period after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Dialysis patients, including referred cases, from the tertiary-care medical center in northern Taiwan.
Criteria

Inclusion Criteria:

  • dialysis patients
  • secondary hyperparathyroidism refractory to medical treatment
  • patients receiving subtotal parathyroidectomy by one surgeon
  • available laboratory data for at least six months after surgery

Exclusion Criteria:

  • patients receiving parathyroidectomy other than subtotal type by other surgeon
  • available laboratory data less than six months after surgery

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): NCT01872429


Locations
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Taiwan
Far Eastern Memorial Hospital
New Taipei City, Taiwan
Sponsors and Collaborators
Far Eastern Memorial Hospital

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Responsible Party: Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT01872429     History of Changes
Other Study ID Numbers: FEMH-IRB-102034-E
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: June 7, 2013
Last Verified: April 2013

Keywords provided by Far Eastern Memorial Hospital:
subtotal parathyroidectomy
calcium
phosphorus
parathyroid hormone
hyperparathyroidism

Additional relevant MeSH terms:
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Hyperparathyroidism
Parathyroid Diseases
Endocrine System Diseases