Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ranjit Aiyagari, University of Michigan
ClinicalTrials.gov Identifier:
NCT00374088
First received: September 7, 2006
Last updated: December 14, 2011
Last verified: December 2011
History of Changes
Results First Received: August 3, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Transposition of Great Vessels
Congenital Heart Disease
Interventions: Drug: N-acetylcysteine
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Patients not treated with N-acetylcysteine
N-acetylcysteine Patients treated with N-acetylcysteine

Participant Flow:   Overall Study
    Placebo     N-acetylcysteine  
STARTED     10     11  
COMPLETED     9     10  
NOT COMPLETED     1     1  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Placebo Patients not treated with N-acetylcysteine
N-acetylcysteine Patients treated with N-acetylcysteine
Total Total of all reporting groups

Baseline Measures
    Placebo     N-acetylcysteine     Total  
Number of Participants  
[units: participants]
 		  10     11     21  
Age  
[units: years]
Mean ± Standard Deviation 		  0.02  ± 0.007     0.02  ± 0.006     0.02  ± 0.007  
Gender  
[units: participants]
 		     
Female     5     3     8  
Male     5     8     13  
Region of Enrollment  
[units: participants]
 		     
United States     10     11     21  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Decline in Measured Cardiac Output   [ Time Frame: 24 hours ]
  Show Outcome Measure 1

2.  Post-Hoc:   Max Creatinine   [ Time Frame: 72 hours ]
  Show Outcome Measure 2

3.  Post-Hoc:   Urine Output   [ Time Frame: 24 hours ]
  Show Outcome Measure 3


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Ranjit Aiyagari, MD
Organization: University of Michigan - Pediatric Cardiology
phone: 734-647-8761
e-mail: ranjita@umich.edu


Publications:


Responsible Party: Ranjit Aiyagari, University of Michigan
ClinicalTrials.gov Identifier: NCT00374088     History of Changes
Other Study ID Numbers: IRBMED No.: 2004-851
Study First Received: September 7, 2006
Results First Received: August 3, 2011
Last Updated: December 14, 2011
Health Authority: United States: Food and Drug Administration