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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01501110
Other study ID # 110061
Secondary ID
Status Completed
Phase Phase 4
First received November 25, 2011
Last updated March 30, 2015
Start date November 2011
Est. completion date November 2013

Study information

Verified date March 2015
Source Federal University of Rio Grande do Sul
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

The propose of this study is to determine whether N-acetylcysteine is effective in reversing the changes in thyroid hormones seen in critical illness, known as the low T3 syndrome.


Description:

The low T3 syndrome or nonthyroidal illness is characterized by low levels of T3, normal or high normal levels of rT3, low or normal levels of T4 and inappropriately normal or low levels of TSH. These changes affect up to 75% of patients and have prognostic implications.

Interleukin-6 (IL6) seems to have a causative role in the pathogenesis of nonthyroidal illness. There is evidence that the reduction in serum T3 was inversely associated with serum IL-6, while the rT3 have a positive association. The mechanism of action of cytokines on the metabolism of thyroid hormones has not been determined and the potential role of cytokines on the deiodases has been the focus of research.

In a cell culture model study, IL-6 was able to suppress the conversion of T4 to T3 by deiodases type 1 and 2 and stimulate the inactivation of T3 by deiodase type 3, a situation similar to nonthyroidal illness. The use of N-acetylcysteine prevented this alterations, been consistent with the hypothesis that IL6 inhibits the function of the deiodases by increasing the oxygen reactive species and by consuming gluthathione or some gluthathione dependent cofactor.

Considering the absence of human studies evaluating the use of N-acetylcysteine in nonthyroidal illness, the aim of this study is to investigate whether NAC has in vivo effect on changes of thyroid hormones.


Recruitment information / eligibility

Status Completed
Enrollment 83
Est. completion date November 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- diagnosis of acute myocardial infarction with less than 12 hours of evolution

- reperfusion therapy (primary angioplasty)

Exclusion Criteria:

- Thyroid disease

- Chronic renal disease with renal replacement therapy

- hepatic insufficiency

- immunosuppression

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Intervention

Drug:
N-acetylcysteine
in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours

Locations

Country Name City State
Brazil Hospital de Clínicas de Porto Alegre Porto Alegre Rio Grande do Sul
Brazil Instituto de Cardiologia Porto Alegre Rio Grande do Sul

Sponsors (3)

Lead Sponsor Collaborator
Federal University of Rio Grande do Sul Hospital de Clinicas de Porto Alegre, Programa de pós-graduação em endocrinologia

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

Bello G, Pennisi MA, Montini L, Silva S, Maviglia R, Cavallaro F, Bianchi A, De Marinis L, Antonelli M. Nonthyroidal illness syndrome and prolonged mechanical ventilation in patients admitted to the ICU. Chest. 2009 Jun;135(6):1448-54. doi: 10.1378/chest.08-1816. Epub 2009 Mar 2. — View Citation

Boelen A, Kwakkel J, Fliers E. Beyond low plasma T3: local thyroid hormone metabolism during inflammation and infection. Endocr Rev. 2011 Oct;32(5):670-93. doi: 10.1210/er.2011-0007. Epub 2011 Jul 26. Review. — View Citation

Koenig RJ. Modeling the nonthyroidal illness syndrome. Curr Opin Endocrinol Diabetes Obes. 2008 Oct;15(5):466-9. doi: 10.1097/MED.0b013e32830eb838. Review. — View Citation

Maia AL, Goemann IM, Meyer EL, Wajner SM. Deiodinases: the balance of thyroid hormone: type 1 iodothyronine deiodinase in human physiology and disease. J Endocrinol. 2011 Jun;209(3):283-97. doi: 10.1530/JOE-10-0481. Epub 2011 Mar 17. Review. — View Citation

Wajner SM, Goemann IM, Bueno AL, Larsen PR, Maia AL. IL-6 promotes nonthyroidal illness syndrome by blocking thyroxine activation while promoting thyroid hormone inactivation in human cells. J Clin Invest. 2011 May;121(5):1834-45. doi: 10.1172/JCI44678. Epub 2011 Apr 11. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Serum T3 Levels at 48 Hours 48 hours No
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