NCT01501110

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 29, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

March 31, 2015

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

1.7 years

First QC Date

November 25, 2011

Results QC Date

December 3, 2014

Last Update Submit

March 30, 2015

Conditions

Acute Myocardial InfarctionEuthyroid Sick SyndromeIschemic Heart Disease

Keywords

Euthyroid Sick Syndromelow T3 syndromedeiodasesoxidative stressischemic heart disease

Outcome Measures

Primary Outcomes (1)

  • Serum T3 Levels at 48 Hours

    48 hours

Study Arms (2)

n-acetylcysteine

ACTIVE COMPARATOR

intra-venous infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours.

Drug: N-acetylcysteine

no intervention

NO INTERVENTION

No intervention

Interventions

N-acetylcysteineDRUG

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

Also known as: NAC, acetylcysteine
n-acetylcysteine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of acute myocardial infarction with less than 12 hours of evolution
  • reperfusion therapy (primary angioplasty)

You may not qualify if:

  • Thyroid disease
  • Chronic renal disease with renal replacement therapy
  • hepatic insufficiency
  • immunosuppression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90540001, Brazil

Location

Instituto de Cardiologia

Porto Alegre, Rio Grande do Sul, 90540001, Brazil

Location

Related Publications (6)

  • 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.

    PMID: 21540553BACKGROUND

  • 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.

    PMID: 21791567BACKGROUND

  • 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.

    PMID: 21415143BACKGROUND

  • 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):1448-1454. doi: 10.1378/chest.08-1816. Epub 2009 Mar 2.

    PMID: 19255297BACKGROUND

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

    PMID: 18769221BACKGROUND

  • Vidart J, Wajner SM, Leite RS, Manica A, Schaan BD, Larsen PR, Maia AL. N-acetylcysteine administration prevents nonthyroidal illness syndrome in patients with acute myocardial infarction: a randomized clinical trial. J Clin Endocrinol Metab. 2014 Dec;99(12):4537-45. doi: 10.1210/jc.2014-2192.

    PMID: 25148231DERIVED

Related Links

MeSH Terms

Conditions

Euthyroid Sick SyndromesMyocardial Ischemia

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System DiseasesHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Josi Vidart
Organization
Hospital de Clínicas de Porto Alegre
josividart@gmail.com
+55 51 98472520

Study Officials

  • Josi Vidart

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

  • Ana maia

    Federal University of Rio Grande do Sul

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 25, 2011

First Posted

December 29, 2011

Study Start

November 1, 2011

Primary Completion

July 1, 2013

Study Completion

November 1, 2013

Last Updated

March 31, 2015

Results First Posted

March 31, 2015

Record last verified: 2015-03

Locations

BR(2)