Trial Outcomes & Findings for Effects of N-acetylcysteine on Low T3 Syndrome (NCT NCT01501110)

NCT ID: NCT01501110

Last Updated: 2015-03-31

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 83 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2015-03-31

Participant Flow

Consecutive patients with a diagnosis of acute myocardial infarction within 12 hours of evolution who underwent primary percutaneous coronary intervention and were admitted to the emergency and intensive care units of two tertiary hospitals in southern Brazil were recruited.

From the 83 patients enrolled, 15 met one of the following pre-established exclusion criteria: age younger than 18 or older than 80 yrs; primary thyroid disease; use of corticosteroids; chronic renal failure; severe hepatic insufficiency; severe immunosuppression; pregnant women or women undergoing postmenopausal hormone replacement.

Participant milestones

Measure	N-acetylcysteine intra-venous infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours. N-acetylcysteine: in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours	no Intervention No intervention / usual care
Overall Study STARTED	34	34
Overall Study COMPLETED	34	33
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	N-acetylcysteine intra-venous infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours. N-acetylcysteine: in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours	no Intervention No intervention / usual care
Overall Study Death	0	1

Baseline Characteristics

Effects of N-acetylcysteine on Low T3 Syndrome

Baseline characteristics by cohort

Measure	N-acetylcysteine n=34 Participants intra-venous infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours. N-acetylcysteine: in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours	no Intervention n=33 Participants No intervention / usual care	Total n=67 Participants Total of all reporting groups
Age, Continuous	56.9 years STANDARD_DEVIATION 9.4 • n=5 Participants	57.4 years STANDARD_DEVIATION 8.4 • n=7 Participants	57 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	24 Participants n=7 Participants	51 Participants n=5 Participants
Region of Enrollment Brazil	34 participants n=5 Participants	33 participants n=7 Participants	67 participants n=5 Participants
TSH	1.7 mcIU/mL STANDARD_DEVIATION 1.2 • n=5 Participants	1.6 mcIU/mL STANDARD_DEVIATION 1.1 • n=7 Participants	1.6 mcIU/mL STANDARD_DEVIATION 1.2 • n=5 Participants
T3	100.4 ng/dL STANDARD_DEVIATION 16.5 • n=5 Participants	98.7 ng/dL STANDARD_DEVIATION 20.7 • n=7 Participants	99.3 ng/dL STANDARD_DEVIATION 17.4 • n=5 Participants
T4	7.4 mcg/dL STANDARD_DEVIATION 1.9 • n=5 Participants	7.4 mcg/dL STANDARD_DEVIATION 1.4 • n=7 Participants	7.4 mcg/dL STANDARD_DEVIATION 1.5 • n=5 Participants
FT4	1.1 ng/dL STANDARD_DEVIATION 0.2 • n=5 Participants	1.1 ng/dL STANDARD_DEVIATION 0.3 • n=7 Participants	1.1 ng/dL STANDARD_DEVIATION 0.2 • n=5 Participants
rT3	54.7 ng/dL STANDARD_DEVIATION 8.1 • n=5 Participants	55.2 ng/dL STANDARD_DEVIATION 6.1 • n=7 Participants	55 ng/dL STANDARD_DEVIATION 7.1 • n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

Outcome measures

Measure	N-acetylcysteine n=34 Participants intra-venous infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours. N-acetylcysteine: in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours	no Intervention n=33 Participants No intervention / usual care
Serum T3 Levels at 48 Hours	93.5 ng/dL Standard Deviation 20.1	96.5 ng/dL Standard Deviation 20.2

Adverse Events

N-acetylcysteine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

no Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Josi Vidart

Hospital de Clínicas de Porto Alegre

Phone: +55 51 98472520

Email: josividart@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place