Hypoparathyroidism PostproceduralNCT04690842
Improving Safety in Pediatric Thyroidectomy by PTH Measurements
An observational study of Hypoparathyroidism Postprocedural, run by Hospital de Niños R. Gutierrez de Buenos Aires.
Trial summary
We implemented a previously reported algorithm based on intra-postoperative PTH measurements with selected cut-off values, both to predict post-thyroidectomy hypoparathyroid hypocalcemia, and to guide postsurgical management. Read more about this study
- Who is it for?
- Ages 2 to 19 years
- Conditions the study is for
- Hypoparathyroidism Postprocedural
- What is being tested?
- PTH measurements post-thyroidectomy (at 5 and 60 min post thyroid removal)
- Type of treatment
- Injection or infusion
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All patients between 2 and 19 years of age who underwent total thyroidectomy at Hospital de Niños Ricardo Gutiérrez in Buenos Aires, Argentina between January 2014 and April 2020 were included. Exclusion criteria were patients with known hyper or hypoparathyroidism, kidney failure, and those taking medications known to affect TCa, PTH, or vitamin D levels (octreotide, oral glucocorticoids, diuretics and antiepileptics), or any other condition that could interfere with calcium metabolism.
Who may be able to join
- Patients who underwent total thyroidectomy between January 2014 and April 2020
Who cannot join
- Patients with known hyper or hypoparathyroidism, kidney failure, and those taking medications known to affect TCa, PTH, or vitamin D levels (octreotide, oral glucocorticoids, diuretics and antiepileptics), or any other condition that could interfere with calcium metabolism
About this study
Official title: Implementation of PTH Measurement Intra / Post Thyroidectomy to Improve Post Surgical Safety in Pediatric Patients
We implemented a previously reported algorithm based on intra-postoperative PTH measurements with selected cut-off values, both to predict post-thyroidectomy hypoparathyroid hypocalcemia, and to guide postsurgical management. The objective of the study was to assess if this strategy was useful to reduce hypocalcemia, post-surgery calcium sampling and hospitalization length.
Read the detailed description
Sixty-six patients were included in the analysis. Based on their intra-operatory PTH determinations, patients were classified according to their post-surgical hypoparathyroidism risk and were either immediately treated with calcium and vitamin D1-25 supplementation (high-risk) or assigned to clinical control and routine calcium sampling (low-risk). The outcomes and overall results of these therapeutical approaches were compared with those of a control group, started on treatment when TCa levels dropped below normal.
In the high-risk subgroup (n=30) five patients showed hypocalcemia within the first 24 hours. Compared with the high-risk control subgroup, the incidence of hypocalcemia fell from 100% to 17% (p<0.001), and the median hospitalization length from 6 to 3 days (p<0.001).
In the low-risk subgroup (n=36) 28 patients remained normocalcemic with significantly less calcium sampling (p<0.001). Eight patients had hypocalcemia; 7 of them required neck dissection, which was the only risk factor related to post-surgical hypoparathyroidism (RR: 2.1 [CI 95% 1.4-3.1], P<0.001).
Compared to the control group, overall incidence of hypocalcemia was reduced by 58 %.
This approach improved patient's safety by reducing the occurrence of hypocalcemia and the length of hospitalization after thyroidectomy in pediatric patients. Preventive calcium supplementation seems to be more beneficial in patients undergoing neck dissection.
- Conditions
- Hypoparathyroidism Postprocedural
- Being tested
- PTH measurements post-thyroidectomy (at 5 and 60 min post thyroid removal)
- Keywords
- Thyroidectomy, PTH, Pediatric surgery, hypocalcemia
- Medical subject headings
- Hypocalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTH measurements post-thyroidectomy (at 5 and 60 min post thyroid removal)Diagnostic test
We implement an algorithm employing PTH levels post-thyroidectomy to stratify patients according to their postsurgical risk for hypoparathyroidism, and to distinctively manage them in the immediate postsurgical period. High risk patients are quickly supplemented with Calcium iv and activated 25OH vitamin D. Low risk patients are clinically controlled and calcium level were checked at 24 and 48 hs post thyroidectomy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical hypocalcemia post thyroidectomy occurrence
total Calcium level < 8 mg/dl
Measured: 48 hours postthyroidectomy
Symptomatic hypocalcemia post thyroidectomy ocurrence
Signs o symptoms of hypocalcemia (Chvostek or Trousseau signs, tingling, numbness, muscle cramps, spasms, tetany or seizures
Measured: 48 hours posthyroidectomy
Secondary outcomes (2)
days of hospitalization after thyroidectomy
number of days that patient need hospitalization (high risk group)
Measured: up to 15 days after thyroidectomy
number of Calcium sampling
number of venipuncture performed to control serum calcium level (low risk group)
Measured: 48 hours postthyroidectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study startJun 2014
- Primary completionApr 2020
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypoparathyroidism PostproceduralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Niños R. Gutierrez de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Analía Freire, Hospital de Niños R. Gutierrez de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690842
- Sponsor's protocol ID
- CEI 19.27
- Status last verified
- Jan 2021
- First submitted
- 28 Dec 2020
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Freire AV, Ropelato MG, Ballerini MG, Acha O, Bergada I, de Papendieck LG, Chiesa A. Predicting hypocalcemia after thyroidectomy in children. Surgery. 2014 Jul;156(1):130-6. doi: 10.1016/j.surg.2014.02.016. Epub 2014 Feb 27.
PubMed 24929763
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of PTH Measurement Intra / Post Thyroidectomy to Improve Post Surgical Safety in Pediatric Patients
- ClinicalTrials.gov ID
- NCT04690842
- Acronym / sponsor ID
- CEI 19.27
- Conditions
- Hypoparathyroidism Postprocedural
- Keywords
- Thyroidectomy, PTH, Pediatric surgery, hypocalcemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Hospital de Niños R. Gutierrez de Buenos AiresUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Apr 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We implemented a previously reported algorithm based on intra-postoperative PTH measurements with selected cut-off values, both to predict post-thyroidectomy hypoparathyroid hypocalcemia, and to guide postsurgical management. The objective of the study was to assess if this strategy was useful to reduce hypocalcemia, post-surgery calcium sampling and hospitalization length.
Detailed description
Sixty-six patients were included in the analysis. Based on their intra-operatory PTH determinations, patients were classified according to their post-surgical hypoparathyroidism risk and were either immediately treated with calcium and vitamin D1-25 supplementation (high-risk) or assigned to clinical control and routine calcium sampling (low-risk). The outcomes and overall results of these therapeutical approaches were compared with those of a control group, started on treatment when TCa levels dropped below normal.
In the high-risk subgroup (n=30) five patients showed hypocalcemia within the first 24 hours. Compared with the high-risk control subgroup, the incidence of hypocalcemia fell from 100% to 17% (p<0.001), and the median hospitalization length from 6 to 3 days (p<0.001).
In the low-risk subgroup (n=36) 28 patients remained normocalcemic with significantly less calcium sampling (p<0.001). Eight patients had hypocalcemia; 7 of them required neck dissection, which was the only risk factor related to post-surgical hypoparathyroidism (RR: 2.1 [CI 95% 1.4-3.1], P<0.001).
Compared to the control group, overall incidence of hypocalcemia was reduced by 58 %.
This approach improved patient's safety by reducing the occurrence of hypocalcemia and the length of hospitalization after thyroidectomy in pediatric patients. Preventive calcium supplementation seems to be more beneficial in patients undergoing neck dissection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All patients between 2 and 19 years of age who underwent total thyroidectomy at Hospital de Niños Ricardo Gutiérrez in Buenos Aires, Argentina between January 2014 and April 2020 were included. Exclusion criteria were patients with known hyper or hypoparathyroidism, kidney failure, and those taking medications known to affect TCa, PTH, or vitamin D levels (octreotide, oral glucocorticoids, diuretics and antiepileptics), or any other condition that could interfere with calcium metabolism.
Key inclusion criteria (1 listed)
- Patients who underwent total thyroidectomy between January 2014 and April 2020
Key exclusion criteria (1 listed)
- Patients with known hyper or hypoparathyroidism, kidney failure, and those taking medications known to affect TCa, PTH, or vitamin D levels (octreotide, oral glucocorticoids, diuretics and antiepileptics), or any other condition that could interfere with calcium metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTH measurements post-thyroidectomy (at 5 and 60 min post thyroid removal)We implement an algorithm employing PTH levels post-thyroidectomy to stratify patients according to their postsurgical risk for hypoparathyroidism, and to distinctively manage them in the immediate postsurgical period. High risk patients are quickly supplemented with Calcium iv and activated 25OH vitamin D. Low risk patients are clinically controlled and calcium level were checked at 24 and 48 hs post thyroidectomy. | Diagnostic test | – |
Primary outcome
Biochemical hypocalcemia post thyroidectomy occurrence
Time frame: 48 hours postthyroidectomy
total Calcium level < 8 mg/dl
Symptomatic hypocalcemia post thyroidectomy ocurrence
Time frame: 48 hours posthyroidectomy
Signs o symptoms of hypocalcemia (Chvostek or Trousseau signs, tingling, numbness, muscle cramps, spasms, tetany or seizures
2 secondary outcomes
days of hospitalization after thyroidectomy
Time frame: up to 15 days after thyroidectomy
number of Calcium sampling
Time frame: 48 hours postthyroidectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Background: PubMed 24929763Freire AV, Ropelato MG, Ballerini MG, Acha O, Bergada I, de Papendieck LG, Chiesa A. Predicting hypocalcemia after thyroidectomy in children. Surgery. 2014 Jul;156(1):130-6. doi: 10.1016/j.surg.2014.02.016. Epub 2014 Feb 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoparathyroidism Postprocedural, run by Hospital de Niños R. Gutierrez de Buenos Aires.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical hypocalcemia post thyroidectomy occurrence (time frame: 48 hours postthyroidectomy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04690842, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.