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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:
ClinicalTrials.gov Identifier:
NCT01301274
First Posted: February 23, 2011
Last Update Posted: March 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospital General de Niños Pedro de Elizalde
Results First Submitted: November 16, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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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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
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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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

2.  Secondary:   Mortality at 28 Days   [ Time Frame: 28 days after admission ]

3.  Secondary:   Mechanical Ventilation Free Days at 28 Day of Admission   [ Time Frame: first 28 day after starting mechanical ventilation ]

4.  Secondary:   ICU Length of Stay   [ Time Frame: 180 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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.


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


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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hospital General de Niños Pedro de Elizalde
ClinicalTrials.gov Identifier: NCT01301274     History of Changes
Other Study ID Numbers: HGNPE-20-2011
First Submitted: February 18, 2011
First Posted: February 23, 2011
Results First Submitted: November 16, 2011
Results First Posted: March 7, 2012
Last Update Posted: March 7, 2012