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Intravenous (IV) Solutions for Dehydration in Children With Gastroenteritis

This study has been terminated.
(Insufficient enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01234883
First Posted: November 4, 2010
Last Update Posted: April 7, 2014
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):
Baxter Healthcare Corporation
Results First Submitted: February 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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 
Overall Participants Analyzed 
[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


  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
Early termination of study due to low enrollment.


  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.


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



Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01234883     History of Changes
Other Study ID Numbers: CSPIVTUSA001
First Submitted: November 3, 2010
First Posted: November 4, 2010
Results First Submitted: February 28, 2014
Results First Posted: April 7, 2014
Last Update Posted: April 7, 2014