HypocalcemiaNCT02853721
Early Prediction of Hypocalcaemia Following Thyroid Surgery
A study testing iPTH and no dosage of iPTH in people with Hypocalcemia, run by University of Cagliari.
Trial summary
150 patients divided into two groups.The experimental group was submitted at the assay of iPTH six hours after surgery whilst the control group was submitted to a daily assay of serum calcium and phosphorus. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypocalcemia
- What is being tested?
- iPTH and no dosage of iPTH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Apr 2015
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Be submitted to total thyroidectomy during the study period
- Have signed the informed consent
Who cannot join
- Lack of inclusion criteria
- Lobectomy with isthmusectomy or partial or subtotal thyroidectomy
- Completion thyroidectomy
- Concomitant hyperparathyroidism was present
- Concomitant treatment with oral calcium and/or vitamin D prior to surgery
About this study
Official title: Early Prediction of Hypocalcaemia Following Thyroid Surgery: A Prospective Randomized Clinical Trial
150 patients divided into two groups.The experimental group was submitted at the assay of iPTH six hours after surgery whilst the control group was submitted to a daily assay of serum calcium and phosphorus.
Read the detailed description
Purpose: The aim of this randomized controlled trial was to validate the results of a previous prospective cohort study conducted in the same surgical unit regarding the use of concomitant intact parathyroid hormone (iPTH) and serum calcium measurement in predicting hypocalcemia after total thyroidectomy.
Methods: From January 2014 to January 2015, 150 patients underwent total thyroidectomy in our department and were divided into two groups. The experimental group was submitted at the assay of iPTH six hours after surgery whilst the control group was submitted to a daily assay of serum calcium and phosphorus. Sensitivity and specificity of different serum measurements have been calculated using the Receiver-operator characteristics (ROC) curve.
- Conditions
- Hypocalcemia
- Being tested
- iPTH, no dosage of iPTH
- Medical subject headings
- Hypocalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPTHOther
iPTH assay six hours after surgery
no dosage of iPTHOther
Ca and P on postoperative day 1 and 2
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | iPTH at 6 hours after surgery Receives: Other: iPTH |
| Control group | Other | no dosage of iPTH Receives: Other: no dosage of iPTH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensibility and specificity of iPTH and serum calcium measurement
Sensitivity and specificity of serum measurement using the Receiver-operator characteristics (ROC) curve
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypocalcemiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandra Saba, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853721
- Sponsor's protocol ID
- PG/2014/9514
- Status last verified
- Jul 2016
- First submitted
- 6 May 2016
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Prediction of Hypocalcaemia Following Thyroid Surgery: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02853721
- Acronym / sponsor ID
- PG/2014/9514
- Conditions
- Hypocalcemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 3 Aug 2016 (estimated)
- 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.
150 patients divided into two groups.The experimental group was submitted at the assay of iPTH six hours after surgery whilst the control group was submitted to a daily assay of serum calcium and phosphorus.
Detailed description
Purpose: The aim of this randomized controlled trial was to validate the results of a previous prospective cohort study conducted in the same surgical unit regarding the use of concomitant intact parathyroid hormone (iPTH) and serum calcium measurement in predicting hypocalcemia after total thyroidectomy.
Methods: From January 2014 to January 2015, 150 patients underwent total thyroidectomy in our department and were divided into two groups. The experimental group was submitted at the assay of iPTH six hours after surgery whilst the control group was submitted to a daily assay of serum calcium and phosphorus. Sensitivity and specificity of different serum measurements have been calculated using the Receiver-operator characteristics (ROC) curve.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: iPTHiPTH at 6 hours after surgery |
| Control group | Other | Other: no dosage of iPTHno dosage of iPTH |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Be submitted to total thyroidectomy during the study period
- Have signed the informed consent
Key exclusion criteria (5 listed)
- Lack of inclusion criteria
- Lobectomy with isthmusectomy or partial or subtotal thyroidectomy
- Completion thyroidectomy
- Concomitant hyperparathyroidism was present
- Concomitant treatment with oral calcium and/or vitamin D prior to surgery
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 |
|---|---|---|
| iPTHiPTH assay six hours after surgery | Other | Experimental group |
| no dosage of iPTHCa and P on postoperative day 1 and 2 | Other | Control group |
Primary outcome
Sensibility and specificity of iPTH and serum calcium measurement
Time frame: 1 month
Sensitivity and specificity of serum measurement using the Receiver-operator characteristics (ROC) curve
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 3 Aug 2016.
- Individual participant dataSharing planned: Undecided
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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?
A study testing iPTH and no dosage of iPTH in people with Hypocalcemia, run by University of Cagliari.
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 2 inclusion and 5 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 3 Aug 2016. 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?
Sensibility and specificity of iPTH and serum calcium measurement (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2016.