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Fluid Resuscitation for Pediatric Diabetic Ketoacidosis

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ClinicalTrials.gov Identifier: NCT01701557
Recruitment Status : Completed
First Posted : October 5, 2012
Last Update Posted : October 5, 2012
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

October 1, 2012
October 5, 2012
October 5, 2012
November 2007
June 2010   (Final data collection date for primary outcome measure)
time to normalization of bicarbonate and pH [ Time Frame: start of treatment until resolution of DKA an expected average of 12 to 24 hours ]
Laboratory parameters were measured hourly for the first 4 hours, and every 2 to3 hours thereafter until acid-base normalization (pH was above 7.3 or the HCO3 was above 15 mmol/L)
Same as current
No Changes Posted
the length of treatment [ Time Frame: discharge from the hospital, an expected average of 1-2 days ]
Length of treatment was defined as a time of the hospital stay after the start of IVF infusion
Same as current
Not Provided
Not Provided
 
Fluid Resuscitation for Pediatric Diabetic Ketoacidosis
Fluid Resuscitation for Pediatric Diabetic Ketoacidosis
Randomized trial to determine if the volume of fluid administration in pediatric patients with DKA impacts the rate of normalization of serum bicarbonate, pH as well as the length of treatment
A randomized trial of two initial volumes of IVF and subsequent administration rates. Group I received 10 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.25 times maintenance and Group II received 20 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.5 times maintenance. The specific variables measured included demographics (age, gender, and race/ethnicity) and routine laboratory values (pH, pCO2, plasma glucose, electrolytes, bicarbonate, sodium, chloride, BUN. Length of treatment was defined as a time of the hospital stay after the start of IVF infusion.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes
  • Other: slow fluid rate
    10 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.25 times maintenance
    Other Name: normal saline
  • Other: fast fluid rate
    20 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.5 times maintenance
    Other Name: normal saline
  • Active Comparator: slow fluid rate
    bolus 10 ml/kg of NS followed by 1.25 times maintenance rate
    Intervention: Other: slow fluid rate
  • Active Comparator: Fast fluid rate
    bolus 20 ml/kg of NS followed by 1.5 times maintenance rate
    Intervention: Other: fast fluid rate
Bakes K, Haukoos JS, Deakyne SJ, Hopkins E, Easter J, McFann K, Brent A, Rewers A. Effect of Volume of Fluid Resuscitation on Metabolic Normalization in Children Presenting in Diabetic Ketoacidosis: A Randomized Controlled Trial. J Emerg Med. 2016 Apr;50(4):551-9. doi: 10.1016/j.jemermed.2015.12.003. Epub 2016 Jan 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
Same as current
June 2010
June 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 1 day to 18 years of age
  • type 1 diabetes
  • presence of DKA, as defined by glucose >250 mg/dl, accumulation of ketone bodies in the blood, and metabolic acidosis (venous pH < 7.30 or serum bicarbonate < 15 mmol/L.)

Exclusion Criteria:

  • requirement for additional fluid resuscitation for hemodynamic instability
  • weight greater than 70 kilograms
Sexes Eligible for Study: All
up to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01701557
06-0846
No
Not Provided
Not Provided
University of Colorado, Denver
University of Colorado, Denver
Not Provided
Principal Investigator: Arleta Rewers, MD University of Colorado, Denver
University of Colorado, Denver
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP