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Trial record 7 of 34 for:    "Diabetic Ketoacidosis"

Cerebral Edema in Pediatric Diabetic Ketoacidosis

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ClinicalTrials.gov Identifier: NCT00629707
Recruitment Status : Completed
First Posted : March 6, 2008
Results First Posted : September 12, 2012
Last Update Posted : September 18, 2012
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
University of California, Davis

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Diabetic Ketoacidosis
Intervention: Other: intravenous fluid treatment

  Participant Flow

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
Slow Fluid Infusion Slower infusion rate: Patients in this arm will receive an initial intravenous fluid bolus of 10cc/Kg followed by rehydration calculated to replace a deficit of 7.5% of body weight over 48 hours.
Rapid Fluid Infusion More rapid infusion: Patients in this arm will receive an initial bolus of 20 cc/Kg of intravenous fluids followed by replacement of an estimated deficit of 10% of body weight over 36 hours plus replacement of 1/2 of urine output volume.

Participant Flow:   Overall Study
    Slow Fluid Infusion   Rapid Fluid Infusion
STARTED   10   10 
COMPLETED   10   8 
NOT COMPLETED   0   2 
Withdrawal by Subject                0                1 
Physician Decision                0                1 



  Baseline Characteristics

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
Slow Fluid Infusion Slower infusion rate: Patients in this arm will receive an initial intravenous fluid bolus of 10cc/Kg followed by rehydration calculated to replace a deficit of 7.5% of body weight over 48 hours.
Rapid Fluid Infusion More rapid infusion: Patients in this arm will receive an initial bolus of 20 cc/Kg of intravenous fluids followed by replacement of an estimated deficit of 10% of body weight over 36 hours plus replacement of 1/2 of urine output volume.
Total Total of all reporting groups

Baseline Measures
   Slow Fluid Infusion   Rapid Fluid Infusion   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   20 
Age 
[Units: Participants]
     
<=18 years   10   10   20 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 14.2  (3.4)   11.4  (1.8)   12.9  (3.1) 
Gender 
[Units: Participants]
     
Female   4   5   9 
Male   6   5   11 
Region of Enrollment 
[Units: Participants]
     
United States   10   10   20 


  Outcome Measures

1.  Primary:   Cerebral Edema Measured by MR Imaging (Apparent Diffusion Coefficient)   [ Time Frame: twice during DKA treatment, once at 3-6 hours and at 9-12 after treatment. A normal comparison measurement will be done after recovery from DKA, at least 72 hours after treatment ]

2.  Secondary:   Brain NAA/Creatine Ratio & Brain Lactate Measured by MR Spectroscopy, Cerebral Blood Flow & Oxygen Saturation Measured by MR Perfusion Weighted Imaging & Near Infrared Spectroscopy, Mental Status Evaluated by Glasgow Coma Scale Scores.   [ Time Frame: twice during DKA treatment, once at 3-6 hours and at 9-12 after treatment. A normal comparison measurement will be done after recovery from DKA, at least 72 hours after treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  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
Study terminated after enrollment of 20 subjects. Review of data from these subjects showed minimal difference between groups and substantial variability suggesting that a larger sample would be very unlikely to show significant differences.


  More Information

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: Dr. Nicole Glaser
Organization: University of California, Davis
phone: 916-734-7098
e-mail: nsglaser@ucdavis.edu


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

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00629707     History of Changes
Other Study ID Numbers: R01NS048610 ( U.S. NIH Grant/Contract )
R01NS052619-01 ( U.S. NIH Grant/Contract )
R01NS052592-01 ( U.S. NIH Grant/Contract )
First Submitted: March 4, 2008
First Posted: March 6, 2008
Results First Submitted: June 18, 2012
Results First Posted: September 12, 2012
Last Update Posted: September 18, 2012