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0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Critically Ill Children (NaCrICh)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospital General de Niños Pedro de Elizalde
ClinicalTrials.gov Identifier:
NCT01301274
First received: February 18, 2011
Last updated: March 6, 2012
Last verified: March 2012
History of Changes
Results First Received: November 16, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hyponatremia
Interventions: Drug: hypotonic
Drug: isotonic

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Intensive Care Unit without cardiovascular patients, since 01/02/2011 until 01/11/2011

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
251 admitted patients to ICU, 97 eligible patients, 9 patients did not give consent, 22 were not randomized by treatment physician

Reporting Groups
  Description
Hypotonic Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids.
Isotonic Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.

Participant Flow:   Overall Study
    Hypotonic     Isotonic  
STARTED     34     32  
COMPLETED     32     31  
NOT COMPLETED     2     1  
Physician Decision                 2                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Hypotonic Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids.
Isotonic Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.
Total Total of all reporting groups

Baseline Measures
    Hypotonic     Isotonic     Total  
Number of Participants  
[units: participants]
 		  34     32     66  
Age  
[units: participants]
 		     
<=18 years     34     32     66  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  3  ± 4.7     1.2  ± 3.2     2.2  ± 4.1  
Gender  
[units: participants]
 		     
Female     14     12     26  
Male     20     20     40  
Region of Enrollment  
[units: participants]
 		     
Argentina     34     32     66  



  Outcome Measures
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1.  Primary:   Serum Sodium Levels in Both Groups   [ Time Frame: first 48 hours ]
  Show Outcome Measure 1

2.  Secondary:   Mortality at 28 Days   [ Time Frame: 28 days after admission ]
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3.  Secondary:   Mechanical Ventilation Free Days at 28 Day of Admission   [ Time Frame: first 28 day after starting mechanical ventilation ]
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4.  Secondary:   ICU Length of Stay   [ Time Frame: 180 days ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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
Limitations: Antidiuretic hormone were not measured.  


Results Point of Contact:  
Name/Title: Dr Facundo Jorro Barón
Organization: Intensive Care Unit - Hospital Pedro de Elizalde
phone: 00541143632100 ext 2035
e-mail: jorrobox@yahoo.com.ar


Publications:


Responsible Party: Hospital General de Niños Pedro de Elizalde
ClinicalTrials.gov Identifier: NCT01301274     History of Changes
Other Study ID Numbers: HGNPE-20-2011
Study First Received: February 18, 2011
Results First Received: November 16, 2011
Last Updated: March 6, 2012
Health Authority: Argentina: Ministry of Health