Intravenous (IV) Solutions for Dehydration in Children With Gastroenteritis

This study has been terminated.
(Insufficient enrollment)
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01234883
First received: November 3, 2010
Last updated: February 28, 2014
Last verified: December 2013
Results First Received: February 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Dehydration
Gastroenteritis
Interventions: Drug: multiple electrolyte solution
Drug: saline

  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
Multiple Electrolyte Solution Plasma Lyte A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP): IV multiple electrolyte solution dosed as clinically indicated for rehydration.
Saline 0.9% Normal Saline: IV saline solution dosed as clinically indicated for rehydration

Participant Flow:   Overall Study
    Multiple Electrolyte Solution     Saline  
STARTED     51     49  
COMPLETED     41     36  
NOT COMPLETED     10     13  
Early treatment release                 8                 10  
Parent/guardian withdrew consent                 1                 2  
Technical difficulties with IV infusion                 0                 1  
Inclusion/exclusion failure                 1                 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.
The ITT population was all subjects who were randomized to receive study treatment. Baseline characteristics include data from participants in the ITT population.

Reporting Groups
  Description
Plasma-Lyte A multiple electrolyte solution: IV multiple electrolyte solution dosed as clinically indicated for rehydration
0.9% Saline saline: IV saline solution dosed as clinically indicated for rehydration
Total Total of all reporting groups

Baseline Measures
    Plasma-Lyte A     0.9% Saline     Total  
Number of Participants  
[units: participants]
  51     49     100  
Age  
[units: months]
Mean ± Standard Deviation
  55.22  ± 32.84     38.14  ± 31.35     46.85  ± 33.09  
Gender  
[units: participants]
     
Female     27     18     45  
Male     24     31     55  



  Outcome Measures

1.  Primary:   Venous Serum Bicarbonate: Modified Intent to Treat Population (mITT); Obtained at Hour 4   [ Time Frame: 4 hour ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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
Early termination of study due to low enrollment.  


Results Point of Contact:  
Name/Title: Drew Jones, M.D.
Organization: Baxter Healthcare
phone: 224-270-2659
e-mail: Drew_Jones@baxter.com


No publications provided


Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01234883     History of Changes
Other Study ID Numbers: CSPIVTUSA001
Study First Received: November 3, 2010
Results First Received: February 28, 2014
Last Updated: February 28, 2014
Health Authority: United States: Institutional Review Board
Canada: Health Canada