Trial Outcomes & Findings for N-Acetylcysteine in Neonatal Congenital Heart Surgery (INACT Study) (NCT NCT00374088)

NCT ID: NCT00374088

Last Updated: 2012-01-19

Results Overview

Serial cardiac output was measured by thermodilution. The outcome of maximum decline in indexed cardiac output from 1 hour postoperative to lowest output within 24 hours postoperative was then calculated and compared between NAC and placebo groups.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 21 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2012-01-19

Participant Flow

Participant milestones

Measure	Placebo Patients not treated with N-acetylcysteine	N-acetylcysteine Patients treated with N-acetylcysteine
Overall Study STARTED	10	11
Overall Study COMPLETED	9	10
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

N-Acetylcysteine in Neonatal Congenital Heart Surgery (INACT Study)

Baseline characteristics by cohort

Measure	Placebo n=10 Participants Patients not treated with N-acetylcysteine	N-acetylcysteine n=11 Participants Patients treated with N-acetylcysteine	Total n=21 Participants Total of all reporting groups
Age Continuous	0.02 years STANDARD_DEVIATION 0.007 • n=5 Participants	0.02 years STANDARD_DEVIATION 0.006 • n=7 Participants	0.02 years STANDARD_DEVIATION 0.007 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	11 participants n=7 Participants	21 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: Patients in which the surgeon was technically able to place a 4 French thermodilution catheter into the pulmonary artery at the time of surgery had cardiac output measured.

Serial cardiac output was measured by thermodilution. The outcome of maximum decline in indexed cardiac output from 1 hour postoperative to lowest output within 24 hours postoperative was then calculated and compared between NAC and placebo groups.

Outcome measures

Measure	Placebo n=9 Participants Patients not treated with N-acetylcysteine	N-acetylcysteine n=10 Participants Patients treated with N-acetylcysteine
Maximum Decline in Measured Cardiac Output	0.68 L/min/m2 Standard Deviation 0.59	0.29 L/min/m2 Standard Deviation 0.56

POST_HOC outcome

Timeframe: 72 hours

Maximum serum creatinine over first 3 days postoperative.

Outcome measures

Measure	Placebo n=9 Participants Patients not treated with N-acetylcysteine	N-acetylcysteine n=10 Participants Patients treated with N-acetylcysteine
Max Creatinine	0.99 mg/dL Standard Deviation 0.44	0.74 mg/dL Standard Deviation 0.24

POST_HOC outcome

Timeframe: 24 hours

Total urine output over the first 24 hours postoperative

Outcome measures

Measure	Placebo n=9 Participants Patients not treated with N-acetylcysteine	N-acetylcysteine n=10 Participants Patients treated with N-acetylcysteine
Urine Output	96 mL Standard Deviation 54	176 mL Standard Deviation 55

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

N-acetylcysteine

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=10 participants at risk Patients not treated with N-acetylcysteine	N-acetylcysteine n=11 participants at risk Patients treated with N-acetylcysteine
Surgical and medical procedures Bleeding requiring surgical re-exploration	0.00% 0/10 • Duration of hospitalization Duration of hospitalization varied by patient	9.1% 1/11 • Number of events 1 • Duration of hospitalization Duration of hospitalization varied by patient
Cardiac disorders Grade II bleeds on head ultrasound	10.0% 1/10 • Number of events 1 • Duration of hospitalization Duration of hospitalization varied by patient	0.00% 0/11 • Duration of hospitalization Duration of hospitalization varied by patient
Surgical and medical procedures Patient placed on ECMO in operating room	0.00% 0/10 • Duration of hospitalization Duration of hospitalization varied by patient	9.1% 1/11 • Number of events 1 • Duration of hospitalization Duration of hospitalization varied by patient

Other adverse events

Measure	Placebo n=10 participants at risk Patients not treated with N-acetylcysteine	N-acetylcysteine n=11 participants at risk Patients treated with N-acetylcysteine
Cardiac disorders Junctional Ectopic Tachycardia	10.0% 1/10 • Number of events 1 • Duration of hospitalization Duration of hospitalization varied by patient	18.2% 2/11 • Number of events 2 • Duration of hospitalization Duration of hospitalization varied by patient
Infections and infestations Persistent fevers	0.00% 0/10 • Duration of hospitalization Duration of hospitalization varied by patient	9.1% 1/11 • Number of events 1 • Duration of hospitalization Duration of hospitalization varied by patient
Endocrine disorders Hypoglycemia	10.0% 1/10 • Number of events 1 • Duration of hospitalization Duration of hospitalization varied by patient	0.00% 0/11 • Duration of hospitalization Duration of hospitalization varied by patient
Renal and urinary disorders Poor urine output	10.0% 1/10 • Number of events 1 • Duration of hospitalization Duration of hospitalization varied by patient	0.00% 0/11 • Duration of hospitalization Duration of hospitalization varied by patient
Vascular disorders Venous congestion of left leg	10.0% 1/10 • Number of events 1 • Duration of hospitalization Duration of hospitalization varied by patient	0.00% 0/11 • Duration of hospitalization Duration of hospitalization varied by patient
Cardiac disorders SVT	10.0% 1/10 • Number of events 1 • Duration of hospitalization Duration of hospitalization varied by patient	18.2% 2/11 • Number of events 2 • Duration of hospitalization Duration of hospitalization varied by patient
Nervous system disorders Seizures	0.00% 0/10 • Duration of hospitalization Duration of hospitalization varied by patient	9.1% 1/11 • Number of events 1 • Duration of hospitalization Duration of hospitalization varied by patient
Respiratory, thoracic and mediastinal disorders Hemothorax	0.00% 0/10 • Duration of hospitalization Duration of hospitalization varied by patient	9.1% 1/11 • Number of events 1 • Duration of hospitalization Duration of hospitalization varied by patient

Additional Information

Ranjit Aiyagari, MD

University of Michigan - Pediatric Cardiology

Phone: 734-647-8761

Email: ranjita@umich.edu

Results disclosure agreements

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