Intravenous (IV) Solutions for Dehydration in Children With Gastroenteritis

Dehydration Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01234883
• Other study ID #: CSPIVTUSA001
• Status: Terminated
• Phase: Phase 4
• First received: November 3, 2010
• Last updated: March 28, 2018
• Start date: June 2011
• Est. completion date: February 2013

Study information

• Verified date: March 2018
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dehydration
• Gastroenteritis

Intervention

Drug:
• multiple electrolyte solution
IV multiple electrolyte solution dosed as clinically indicated for rehydration
• saline
IV solutions dosed as clinically indicated for rehydration

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	British Columbia Children's Hospital	Vancouver	British Columbia
United States	Children's Hospital of Atlanta at Scottish Rite	Atlanta	Georgia
United States	Emory University/Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Dell Children's Medical Center of Central Texas	Austin	Texas
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)