Transient HypoparathyroidismPhase 4CorthyroidNCT02652884
Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy
A Phase 4 study testing phosphate and betamethasone acetate, 2 mL. and saline 0.9% NaCl in people with Transient Hypoparathyroidism, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
The incidence of thyroid cancer (TC) has increased exponentially worldwide. The increase in diagnosed cases brings about an increase in the number of surgeries performed on the thyroid gland, especially total thyroidectomy (TT), given that at present is still the gold standard of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transient Hypoparathyroidism
- What is being tested?
- phosphate and betamethasone acetate, 2 mL. and saline 0.9% NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteArgentina
- Study dates
- Jan 2016to Dec 2017
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult
- thyroidectomy postoperative
- prepaid affiliate patients
Who cannot join
- allergy
- CKD
- idiophatic thrombocytopenic purpura
- hyperthyroidism
- chronic use of corticoids
- no follicular cancer, nonpapillary
- refusal to participate
Trial locations and contacts
1 site in 1 country.
Diego H Giunta, MD contact
Juan Achaval Rodriguez, MD contact
Argentina1 site, 1 recruiting
- Recruiting
Hospital Italiano de Buenos Aires
Buenos Aires, Buenos Aires F.D., C1181ACH
Diego Giunta, MD, (05411)49590200 ext. 4419, diego.giunta@hospitalitaliano.org.ar
Diego Giunta, MD
About this study
Official title: Evaluation of Potential Benefits of Using Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy
The incidence of thyroid cancer (TC) has increased exponentially worldwide. The increase in diagnosed cases brings about an increase in the number of surgeries performed on the thyroid gland, especially total thyroidectomy (TT), given that at present is still the gold standard of treatment.
Transient postoperative hypoparathyroidism (HPT) is one of the most frequent complications, with an incidence of between 10 and 46% according to different sources. HPT involves longer hospital stay, serial measurements of blood glucose, treatment with calcium and vitamin D (with potential risk of hypercalcemia) and therefore an increase in terms of the costs of the health system.
Read more
While the investigators know the analgesic, anti-inflammatory, immunomodulatory and anti emetic of corticosteroids in thyroid surgery, the literature available to date is discordant in the use of steroid and its interaction with the HPT making clear the need for randomized clinical trials specific to analyze these variables more accurately.
As inflammation and edema constitute a proposed surgical manipulation in the pathogenesis of HPT component, investigators decided t conduct a prospective randomized, triple-blind, in order to assess the potential benefits of the most common postoperative complication reported in TT.
Our primary objective is to evaluate the safety and efficacy of single-dose corticosteroids deposit immediately postintubation in preventing the development of transient hypoparathyroidism (PTH, serum calcium and symptoms) in patients after TT.
Read the detailed description
Triple-blind randomized clinical trial
- Conditions
- Transient Hypoparathyroidism
- Being tested
- phosphate and betamethasone acetate, 2 mL., saline 0.9% NaCl
- Keywords
- transient hypoparathyroidism, steroids, total thyroidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phosphate and betamethasone acetate, 2 mL.Drug
Also called cronodose
single dose of intramuscular depot corticosteroid
saline 0.9% NaClDrug
Also called placebo
single dose of intramuscular placebo
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | will receive single dose intramuscular corticosteroid deltoid deposit (as phosphate and betamethasone acetate, 2 mL) for immediate postintubation. Receives: Drug: phosphate and betamethasone acetate, 2 mL. |
| Group 2 | Placebo comparator | will receive 2 ml saline 0.9% NaCl in deltoid immediately postintubation. Receives: Drug: saline 0.9% NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Hypocalcemia
Serial postoperative blood samples will be made to detect hypocalcemia (defined as <8,5 mg/dL)
- at 1 hour postoperative from skin closure,
- at 6 hours after surgery
- 24 hours
- 72 hours
Measured: 3 days
Secondary outcomes (1)
Related Adverse Events
Any negative effects of corticosteroids will be also recorded in the postoperative and during 30 days follow up after surgery.
Major side effects associated with glucocorticoid therapy are:
Gastrointestinal (Gastritis, Peptic ulcer disease, Pancreatitis, Steatohepatitis, Visceral perforation) Dermatologic and soft tissue (Skin thinning and purpura) Cardiovascular (Arrhythmias, Hypertension, Hypotension)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transient HypoparathyroidismStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan Achaval, MD, Principal investigator, Hospital Italiano de Buenos AiresFigari Marcelo, MD, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652884
- Sponsor's protocol ID
- 2627
- Acronym
- Corthyroid
- Status last verified
- Jan 2016
- First submitted
- 5 Jan 2016
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Potential Benefits of Using Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy
- ClinicalTrials.gov ID
- NCT02652884
- Acronym / sponsor ID
- Corthyroid / 2627
- Conditions
- Transient Hypoparathyroidism
- Keywords
- transient hypoparathyroidism, steroids, total thyroidectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 12 Jan 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.
The incidence of thyroid cancer (TC) has increased exponentially worldwide. The increase in diagnosed cases brings about an increase in the number of surgeries performed on the thyroid gland, especially total thyroidectomy (TT), given that at present is still the gold standard of treatment.
Transient postoperative hypoparathyroidism (HPT) is one of the most frequent complications, with an incidence of between 10 and 46% according to different sources. HPT involves longer hospital stay, serial measurements of blood glucose, treatment with calcium and vitamin D (with potential risk of hypercalcemia) and therefore an increase in terms of the costs of the health system.
While the investigators know the analgesic, anti-inflammatory, immunomodulatory and anti emetic of corticosteroids in thyroid surgery, the literature available to date is discordant in the use of steroid and its interaction with the HPT making clear the need for randomized clinical trials specific to analyze these variables more accurately.
As inflammation and edema constitute a proposed surgical manipulation in the pathogenesis of HPT component, investigators decided t conduct a prospective randomized, triple-blind, in order to assess the potential benefits of the most common postoperative complication reported in TT.
Our primary objective is to evaluate the safety and efficacy of single-dose corticosteroids deposit immediately postintubation in preventing the development of transient hypoparathyroidism (PTH, serum calcium and symptoms) in patients after TT.
Detailed description
Triple-blind randomized clinical trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: phosphate and betamethasone acetate, 2 mL.will receive single dose intramuscular corticosteroid deltoid deposit (as phosphate and betamethasone acetate, 2 mL) for immediate postintubation. |
| Group 2 | Placebo comparator | Drug: saline 0.9% NaClwill receive 2 ml saline 0.9% NaCl in deltoid immediately postintubation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult
- thyroidectomy postoperative
- prepaid affiliate patients
Key exclusion criteria (7 listed)
- allergy
- CKD
- idiophatic thrombocytopenic purpura
- hyperthyroidism
- chronic use of corticoids
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 |
|---|---|---|
| phosphate and betamethasone acetate, 2 mL.Also: cronodosesingle dose of intramuscular depot corticosteroid | Drug | Group 1 |
| saline 0.9% NaClAlso: placebosingle dose of intramuscular placebo | Drug | Group 2 |
Primary outcome
Postoperative Hypocalcemia
Time frame: 3 days
Serial postoperative blood samples will be made to detect hypocalcemia (defined as <8,5 mg/dL) 1. at 1 hour postoperative from skin closure, 2. at 6 hours after surgery 3. 24 hours 4. 72 hours
1 secondary outcome
Related Adverse Events
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2016.
- Individual participant dataSharing planned: Undecided
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.
Diego H Giunta, MD contact
Juan Achaval Rodriguez, MD contact
Juan Achaval, MD principal investigator
Hospital Italiano de Buenos Aires
Figari Marcelo, MD principal investigator
Hospital Italiano de Buenos Aires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing phosphate and betamethasone acetate, 2 mL. and saline 0.9% NaCl in people with Transient Hypoparathyroidism, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 5 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diego H Giunta, MD (diego.giunta@hospitalitaliano.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Hypocalcemia (time frame: 3 days). 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 5 Apr 2016.