Hyperparathyroidism and Dialysis Adequacy in Hemodialysis Patients
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University
About this trial
This cross-sectional study aims to determine the prevalence of secondary hyperparathyroidism among end-stage renal disease patients on regular hemodialysis and to evaluate its relationship with dialysis adequacy at Assiut University Hospitals.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
- Age 18 years or older
Diagnosed with end-stage renal disease
Maintained on regular thrice-weekly hemodialysis for at least three consecutive months
Written informed consent
Disqualifiers
- Primary hyperparathyroidism or prior parathyroidectomy
Active severe infections or acute systemic illnesses
Active malignancy
Severe hepatic dysfunction or chronic liver cirrhosis
Trial population
Adult patients with end-stage renal disease maintained on regular thrice-weekly hemodialysis for at least three months at the Hemodialysis Unit, Nephrology Department, Assiut University Hospitals.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
130 Participants
are grouped into 1 trial groupGroup A: Single cohort: ESRD patients on regular hemodialysis
Trial outcomes
Primary outcomes
1
Prevalence of secondary hyperparathyroidism
Proportion of patients with elevated intact parathyroid hormone (iPTH) levels above the target range (greater than 9 times the upper limit of normal) among regular hemodialysis patients.
Time frame
BaselineSecondary outcomes
1
Prevalence of adequate dialysis
Proportion of patients achieving target dialysis adequacy defined as single-pool Kt/V (spKt/V) ≥ 1.2 or urea reduction ratio (URR) ≥ 65%.
Time frame
Baseline2
Correlation between dialysis adequacy and iPTH level
Correlation coefficient between dialysis adequacy parameters (spKt/V and URR) and serum intact parathyroid hormone (iPTH) levels, using Spearman or Pearson correlation as appropriate.
Time frame
Baseline3
Serum phosphate levels according to dialysis adequacy
Mean serum phosphate concentration (mg/dL) in patients with adequate versus inadequate dialysis.
Time frame
Baseline4
Serum calcium level
Mean serum calcium concentration (mg/dL) in patients with secondary hyperparathyroidism.
Time frame
BaselineLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: