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

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ClinicalTrials.gov Identifier: NCT00374088
Recruitment Status : Completed
First Posted : September 8, 2006
Results First Posted : January 19, 2012
Last Update Posted : January 19, 2012
Sponsor:
Information provided by (Responsible Party):
Ranjit Aiyagari, University of Michigan

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Transposition of Great Vessels
Congenital Heart Disease
Interventions: Drug: N-acetylcysteine
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 
Overall Participants Analyzed 
[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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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


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
First Submitted: September 7, 2006
First Posted: September 8, 2006
Results First Submitted: August 3, 2011
Results First Posted: January 19, 2012
Last Update Posted: January 19, 2012