Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy (Corthyroid)
Primary Purpose
Transient Hypoparathyroidism
Status
Unknown status
Phase
Phase 4
Locations
Argentina
Study Type
Interventional
Intervention
phosphate and betamethasone acetate, 2 mL.
saline 0.9% NaCl
Sponsored by
About this trial
This is an interventional treatment trial for Transient Hypoparathyroidism focused on measuring transient hypoparathyroidism, steroids, total thyroidectomy
Eligibility Criteria
Inclusion Criteria:
- adult
- thyroidectomy postoperative
- prepaid affiliate patients
Exclusion Criteria:
- allergy
- CKD
- idiophatic thrombocytopenic purpura
- hyperthyroidism
- chronic use of corticoids
- no follicular cancer, nonpapillary
- refusal to participate
Sites / Locations
- Hospital Italiano de Buenos AiresRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group 1
Group 2
Arm Description
will receive single dose intramuscular corticosteroid deltoid deposit (as phosphate and betamethasone acetate, 2 mL) for immediate postintubation.
will receive 2 ml saline 0.9% NaCl in deltoid immediately postintubation.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT02652884
First Posted
January 5, 2016
Last Updated
April 4, 2016
Sponsor
Hospital Italiano de Buenos Aires
1. Study Identification
Unique Protocol Identification Number
NCT02652884
Brief Title
Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy
Acronym
Corthyroid
Official Title
Evaluation of Potential Benefits of Using Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Italiano de Buenos Aires
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transient Hypoparathyroidism
Keywords
transient hypoparathyroidism, steroids, total thyroidectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
will receive single dose intramuscular corticosteroid deltoid deposit (as phosphate and betamethasone acetate, 2 mL) for immediate postintubation.
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
will receive 2 ml saline 0.9% NaCl in deltoid immediately postintubation.
Intervention Type
Drug
Intervention Name(s)
phosphate and betamethasone acetate, 2 mL.
Other Intervention Name(s)
cronodose
Intervention Description
single dose of intramuscular depot corticosteroid
Intervention Type
Drug
Intervention Name(s)
saline 0.9% NaCl
Other Intervention Name(s)
placebo
Intervention Description
single dose of intramuscular placebo
Primary Outcome Measure Information:
Title
Postoperative Hypocalcemia
Description
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
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Related Adverse Events
Description
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)
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult
thyroidectomy postoperative
prepaid affiliate patients
Exclusion Criteria:
allergy
CKD
idiophatic thrombocytopenic purpura
hyperthyroidism
chronic use of corticoids
no follicular cancer, nonpapillary
refusal to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diego H Giunta, MD
Email
diego.giunta@hospitalitaliano.org.ar
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Achaval Rodriguez, MD
Email
juan.achaval@hospitalitaliano.org.ar
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Achaval, MD
Organizational Affiliation
Hospital Italiano de Buenos Aires
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Figari Marcelo, MD
Organizational Affiliation
Hospital Italiano de Buenos Aires
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Italiano de Buenos Aires
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diego Giunta, MD
Phone
(05411)49590200
Ext
4419
Email
diego.giunta@hospitalitaliano.org.ar
First Name & Middle Initial & Last Name & Degree
Diego Giunta, MD
First Name & Middle Initial & Last Name & Degree
Veronica Gonzalez, BA
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy
We'll reach out to this number within 24 hrs