CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Intraoperative Paratohormoneother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04484116
NCT04484116N/ACompleted
CompareCT.gov

USEFULNESS OF IOPTH AS A PREDICTOR FOR SUCCESSFUL PARATHYROIDECTOMY IN SECONDARY HYPERPARATHYROIDISM: A COHORT STUDY

Hospital General Ajusco Medio·observational·Posted Jul 23, 2020·Updated Jul 23, 2020

In Brief

An observational study evaluating Intraoperative Paratohormone for Secondary Hyperparathyroidism. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Secondary hyperparathyroidism (SHPT) is a multisystemic syndrome that affects calcium and bone homeostasis in patients with chronic kidney disease (CKD). Despite medical treatment, 1-2% of patients require parathyroidectomy anually. The use of an intraoperative paratohormone protocol (IOPTH) to predict cure still in debate, due to the lack of standardized protocols, the use of different assays and uneven PTH clearance. The aim of this study was to determine the diagnostic accuracy of an IOPTH in patients with SHPT for predicting successful surgery after parathyroidectomy.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsSecondary Hyperparathyroidism
CountriesMexico
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJul 23, 2020
Enrollment StartJul 1, 2017
Primary CompletionNov 30, 2019
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 5.9 years ago

Interventions

Intraoperative Paratohormoneother

Three IOPTH determinations were withdrawn: at anesthetic induction (PTH0), 15 minutes (PTH15), and 30 minutes (PTH30) after completion gland resection. Another sample was taken 24 hours after the procedure (PTH24), values \<150pg/mL defined a successful surgery and patients were assigned to the successful or unsuccessful group. IOPTH drop was analyzed to predict successful surgery with drops of 70% and 90% at 15 and 30 minutes.