Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Two Bag System for Hydration in Diabetes

This study has been terminated.
(Monitoring Committee found significant & meaningful difference on main outcome)
Sponsor:
Information provided by (Responsible Party):
Hospital General de Niños Pedro de Elizalde
ClinicalTrials.gov Identifier:
NCT01631929
First received: June 25, 2012
Last updated: October 21, 2016
Last verified: October 2016
Results First Received: August 19, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Diabetes
Ketoacidosis
Interventions: Other: One bag
Other: Two bags

  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
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
One Bag

IV infusion of fluids, electrolytes and dextrose using one bag

One bag: Infusion of dextrose and electrolytes using one bag

Two Bags

Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.

Two bags: Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.


Participant Flow:   Overall Study
    One Bag   Two Bags
STARTED   6   6 
COMPLETED   6   6 
NOT COMPLETED   0   0 



  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
One Bag

IV infusion of fluids, electrolytes and dextrose using one bag

One bag: Infusion of dextrose and electrolytes using one bag

Two Bags

Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.

Two bags: Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.

Total Total of all reporting groups

Baseline Measures
   One Bag   Two Bags   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   6   12 
Age 
[Units: Participants]
     
<=18 years   6   6   12 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 8.83  (1.7)   9.67  (2.7)   9.2  (3.4) 
Gender 
[Units: Participants]
     
Female   5   5   10 
Male   1   1   2 
Disease debuted 
[Units: Participants]
     
Yes   4   2   6 
Not   2   4   6 


  Outcome Measures

1.  Primary:   Time to Achieve Patient Stabilization   [ Time Frame: Participants werer followed for the duration of ketoacidosis (an expected average of 12 hours) ]


  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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Ferreira Juan Pablo MD
Organization: HOSPITAL GENERAL DE NIÑOS PEDRO DE ELIZALDE
phone: +5491136085959
e-mail: ferreirajuanpablo@hotmail.com


Publications of Results:
Other Publications:

Responsible Party: Hospital General de Niños Pedro de Elizalde
ClinicalTrials.gov Identifier: NCT01631929     History of Changes
Other Study ID Numbers: 65-HGNPE-2012
Study First Received: June 25, 2012
Results First Received: August 19, 2015
Last Updated: October 21, 2016
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica