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

Sponsor
Far Eastern Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01872429
Collaborator
(none)
401
1
5
80.8

Study Details

Study Description

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 Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    401 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Study Start Date :
    Nov 1, 2012
    Actual Primary Completion Date :
    Apr 1, 2013
    Actual Study Completion Date :
    Apr 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Far Eastern Memorial Hospital New Taipei City Taiwan

    Sponsors and Collaborators

    • Far Eastern Memorial Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Far Eastern Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT01872429
    Other Study ID Numbers:
    • FEMH-IRB-102034-E
    First Posted:
    Jun 7, 2013
    Last Update Posted:
    Jun 7, 2013
    Last Verified:
    Apr 1, 2013
    Keywords provided by Far Eastern Memorial Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 7, 2013