Intravenous (IV) Solutions for Dehydration in Children With Gastroenteritis

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

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.

Study Overview

• Status: Terminated
• Conditions: Gastroenteritis; Dehydration
• Intervention / Treatment: Drug: multiple electrolyte solution; Drug: saline

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3B 6A8
      • Alberta Children's Hospital
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3V4
      • British Columbia Children's Hospital
• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University/Children's Healthcare of Atlanta
    • Atlanta, Georgia, United States, 30342
      • Children's Hospital of Atlanta at Scottish Rite
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Texas
    • Austin, Texas, United States, 78723
      • Dell Children's Medical Center of Central Texas
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Children's Hospital of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: multiple electrolyte solution; Subjects were randomized to receive either multiple electrolyte solution or saline. These solutions were administered IV at 10-20 mL/kg until the subject appeared clinically rehydrated as assessed by the clinician. The selected dose for these solutions is considered standard of care when treating clinical dehydration in children and is consistent with product labeling.	Drug: multiple electrolyte solution; IV multiple electrolyte solution dosed as clinically indicated for rehydration; Other Names: Plasma Lyte A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP)
Active Comparator: saline; Subjects were randomized to receive either multiple electrolyte solution or saline. These solutions were administered IV at 10-20 mL/kg until the subject appeared clinically rehydrated as assessed by the clinician. The selected dose for these solutions is considered standard of care when treating clinical dehydration in children and is consistent with product labeling.	Drug: saline; IV solutions dosed as clinically indicated for rehydration; Other Names: 0.9% Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline of Venous Serum Bicarbonate at 4 Hours From Start of Intravenous (IV)	The primary efficacy variable was venous serum bicarbonate (marker of metabolic acidosis) at Hour 4 (+/- 1 hour) from the start of the First IV Bolus.	Day 1 (4 Hours after start of IV)

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation
• Investigators: Study Director: Drew Jones, MD, Baxter Healthcare

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: November 3, 2010
• First Submitted That Met QC Criteria: November 3, 2010
• First Posted (Estimate): November 4, 2010

Study Record Updates

• Last Update Posted (Actual): April 26, 2018
• Last Update Submitted That Met QC Criteria: March 28, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: gastroenteritis; dehydration
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Metabolic Diseases; Gastrointestinal Diseases; Water-Electrolyte Imbalance; Gastroenteritis; Dehydration; Pharmaceutical Solutions; Ophthalmic Solutions; Plasma-lyte 148
• Other Study ID Numbers: CSPIVTUSA001