Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy (Corthyroid)

• ClinicalTrials.gov Identifier: NCT02652884
• Recruitment Status: Unknown
• First Posted: January 12, 2016
• Last Update Posted: April 5, 2016
• Sponsor: Hospital Italiano de Buenos Aires
• Information provided by (Responsible Party): Hospital Italiano de Buenos Aires

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.

Condition or disease	Intervention/treatment	Phase
Transient Hypoparathyroidism	Drug: phosphate and betamethasone acetate, 2 mL.; Drug: saline 0.9% NaCl	Phase 4

Detailed Description:

Triple-blind randomized clinical trial

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluation of Potential Benefits of Using Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy
• Study Start Date: January 2016
• Estimated Primary Completion Date: December 2016
• Estimated Study Completion Date: December 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group 1; will receive single dose intramuscular corticosteroid deltoid deposit (as phosphate and betamethasone acetate, 2 mL) for immediate postintubation.	Drug: phosphate and betamethasone acetate, 2 mL.; single dose of intramuscular depot corticosteroid; Other Name: cronodose
Placebo Comparator: Group 2; will receive 2 ml saline 0.9% NaCl in deltoid immediately postintubation.	Drug: saline 0.9% NaCl; single dose of intramuscular placebo; Other Name: placebo

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Related Adverse Events [ Time Frame: 30 days ]

   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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Diego H Giunta, MD; diego.giunta@hospitalitaliano.org.ar

Contact: Juan Achaval Rodriguez, MD; juan.achaval@hospitalitaliano.org.ar

Locations

Argentina

Hospital Italiano de Buenos Aires; Recruiting

Ciudad Autonoma de Buenos Aires, Argentina, C1181ACH

Contact: Diego Giunta, MD (05411)49590200 ext 4419 diego.giunta@hospitalitaliano.org.ar

Principal Investigator: Diego Giunta, MD

Principal Investigator: Veronica Gonzalez, BA

Sponsors and Collaborators

Hospital Italiano de Buenos Aires

Investigators

• Principal Investigator: Juan Achaval, MD; Hospital Italiano de Buenos Aires
• Principal Investigator: Figari Marcelo, MD; Hospital Italiano de Buenos Aires

More Information

• Responsible Party: Hospital Italiano de Buenos Aires
• ClinicalTrials.gov Identifier: NCT02652884
• Other Study ID Numbers: 2627
• First Posted: January 12, 2016
• Last Update Posted: April 5, 2016
• Last Verified: January 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Hospital Italiano de Buenos Aires:

transient hypoparathyroidism; steroids; total thyroidectomy

Additional relevant MeSH terms:

Hypoparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Betamethasone; Betamethasone acetate; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents