Dehydration, Gastroenteritis
Conditions
Keywords
dehydration, gastroenteritis
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.
Interventions
DRUGmultiple electrolyte solution
IV multiple electrolyte solution dosed as clinically indicated for rehydration
DRUGsaline
IV solutions dosed as clinically indicated for rehydration
Sponsors
Baxter Healthcare Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 10 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline of Venous Serum Bicarbonate at 4 Hours From Start of Intravenous (IV) | Day 1 (4 Hours after start of 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Plasma-Lyte A multiple electrolyte solution: IV multiple electrolyte solution dosed as clinically indicated for rehydration | 51 |
| 0.9% Saline saline: IV saline solution dosed as clinically indicated for rehydration | 49 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Early treatment release | 8 | 10 |
| Overall Study | Inclusion/exclusion failure | 1 | 0 |
| Overall Study | Parent/guardian withdrew consent | 1 | 2 |
| Overall Study | Technical difficulties with IV infusion | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Plasma-Lyte A | 0.9% Saline |
|---|---|---|---|
| Age, Continuous | 46.85 months STANDARD_DEVIATION 33.09 | 55.22 months STANDARD_DEVIATION 32.84 | 38.14 months STANDARD_DEVIATION 31.35 |
| Sex: Female, Male Female | 45 Participants | 27 Participants | 18 Participants |
| Sex: Female, Male Male | 55 Participants | 24 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 46 | 8 / 45 |
| serious Total, serious adverse events | 1 / 46 | 0 / 45 |
Outcome results
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.
Time frame: Day 1 (4 Hours after start of IV)
Population: The mITT population is all subjects with Baseline bicarbonate value ≤ 22 mmol/L. The mITT population was used for efficacy evaluation. The AT analysis set was defined as all subjects who received at least 5 mL of study treatment and were classified according to actual treatment received. AT population was used for AE analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Multiple Electrolyte Solution | Change From Baseline of Venous Serum Bicarbonate at 4 Hours From Start of Intravenous (IV) | 1.63 mmol/L | Standard Deviation 2.54 |
| Saline | Change From Baseline of Venous Serum Bicarbonate at 4 Hours From Start of Intravenous (IV) | 0.00 mmol/L | Standard Deviation 2.25 |
p-value: <0.05ANOVA