Clinical trial NCT01234883: Intravenous (IV) Solutions for Dehydration in Children With Gastroenteritis
Official title: A Double-Blind, Randomized, Comparative Efficacy and Safety Trial of Intravenous Solutions for the Treatment of Moderate to Severe Dehydration in Children With Acute Gastroenteritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Dehydration
Gastroenteritis
Keywords: dehydration
gastroenteritis
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2010-11-04
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to compare the efficacy and safety of the use of a multiple electrolyte solution to the use of saline for the treatment of moderate to severe dehydration due to acute gastroenteritis (AGE) in children.

Detailed description: The primary objective of this study was to compare the efficacy and safety of the use of Plasma Lyte A to the use of NS for the treatment of moderate to severe dehydration and amelioration of metabolic acidosis due to AGE in children (≥ 6 months to \< 11 years of age) by measuring serum bicarbonate levels.

Eligibility criteria: Inclusion Criteria:

1. AGE (etiology: viral or other) resulting in presentation to the ED deemed in need of IV rehydration. In the 24 hours prior to presentation, the subject experienced at least 3 episodes of diarrhea (loose and/or watery stools) and/or nonbilious vomiting.
2. Moderate to severe dehydration (as assessed by Gorelick score13 ≥ 4
3. ≥ 6 months to \< 11 years of age.
4. Healthy except for the underlying etiology of AGE.
5. Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written ICFs and privacy language per national regulations (eg, Health Insurance Portability and Accountability Act \[HIPAA\], Personal Information Protection and Electronic Documents Act \[PIPEDA\]) were obtained from the parent/guardian prior to any study-related procedures.

Exclusion Criteria:

1. AGE that did not require IV rehydration per the clinician.
2. Gorelick score ≤ 3
3. Bilious vomiting.
4. Received \> 20 mL/kg IV fluid bolus within the 4 hours prior to study enrollment (ie, Hour -4 to Hour 0).
5. Diarrhea lasting \> 7 days prior to presentation to the ED.
6. Chronic vomiting disorder.
7. Grossly bloody diarrhea.
8. Chronic diarrheal disorder.
9. Known hyponatremia (sodium \< 130 mmol/L \[\< 130 mEq/L\]) within 72 hours prior to enrollment.
10. Known hypernatremia (sodium \> 155 mmol/L \[\> 155 mEq/L\]) within 72 hours prior to enrollment.
11. Known hypokalemia (potassium \< 3.0 mmol/L \[\< 3.0 mEq/L\]) within 72 hours prior to enrollment.
12. Known hyperkalemia (potassium \> 5.5 mmol/L \[\> 5.5 mEq/L\]) within 72 hours prior to enrollment.
13. The use of prohibited medications:

    * Antacids within 24 hours prior to presentation to the ED and during the study.
    * Anti-diarrhea medication within 24 hours prior to presentation to the ED and during the study.
    * The systemic use of corticosteroids/corticotropins was prohibited within 72 hours of enrollment.
14. Chronic health condition affecting the ability to tolerate fluids or those that result in electrolyte abnormalities (eg, chronic renal, cardiac, or pulmonary diagnoses), or abnormalities of sodium or potassium handling (eg, endocrine disorders, medications).
15. Any reason for urgent or emergency hospital admission or ED stays of \> 12 hours within 14 days preceding presentation to the ED.
16. Any medical condition likely to interfere with the subject's ability to fully complete all protocol-specified interventions, the ability to undergo all protocol-specified assessments, or likely to prolong the subject's need for medical attention beyond that required for treatment of dehydration.
17. Participation in a study of any investigational drug or device concomitantly or within 30 days prior to enrollment in this study, including previous enrollment in this study.
18. Subject with a \> 50% expected chance of dying within 6 months, in the Investigator's opinion.
19. Known hypersensitivity to either of the investigational products.
20. Other serious acute or active conditions that, in the Investigator's opinion, precluded participation in this study.

Primary outcomes:
measure: Change From Baseline of Venous Serum Bicarbonate at 4 Hours From Start of Intravenous (IV)
timeFrame: Day 1 (4 Hours after start of IV)
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University/Children's Healthcare of Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Children's Hospital of Atlanta at Scottish Rite
state: Georgia
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Austin
country: United States
facility: Dell Children's Medical Center of Central Texas
state: Texas
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital
state: British Columbia
Study officials:
affiliation: Baxter Healthcare
name: Drew Jones, MD
role: STUDY_DIRECTOR
References:
citation: Allen CH, Goldman RD, Bhatt S, Simon HK, Gorelick MH, Spandorfer PR, Spiro DM, Mace SE, Johnson DW, Higginbotham EA, Du H, Smyth BJ, Schermer CR, Goldstein SL. A randomized trial of Plasma-Lyte A and 0.9 % sodium chloride in acute pediatric gastroenteritis. BMC Pediatr. 2016 Aug 2;16:117. doi: 10.1186/s12887-016-0652-4.