Trial Outcomes & Findings for Intravenous (IV) Solutions for Dehydration in Children With Gastroenteritis (NCT NCT01234883)

Last Updated: 2018-04-26

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

Day 1 (4 Hours after start of IV)

Results posted on

2018-04-26

Participant Flow

Participant milestones

Participant milestones
Measure	Multiple Electrolyte Solution Plasma Lyte A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP): IV multiple electrolyte solution dosed as clinically indicated for rehydration.	Saline 0.9% Normal Saline: IV saline solution dosed as clinically indicated for rehydration
Overall Study STARTED	51	49
Overall Study COMPLETED	41	36
Overall Study NOT COMPLETED	10	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Multiple Electrolyte Solution Plasma Lyte A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP): IV multiple electrolyte solution dosed as clinically indicated for rehydration.	Saline 0.9% Normal Saline: IV saline solution dosed as clinically indicated for rehydration
Overall Study Early treatment release	8	10
Overall Study Parent/guardian withdrew consent	1	2
Overall Study Technical difficulties with IV infusion	0	1
Overall Study Inclusion/exclusion failure	1	0

Baseline Characteristics

Intravenous (IV) Solutions for Dehydration in Children With Gastroenteritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Plasma-Lyte A n=51 Participants multiple electrolyte solution: IV multiple electrolyte solution dosed as clinically indicated for rehydration	0.9% Saline n=49 Participants saline: IV saline solution dosed as clinically indicated for rehydration	Total n=100 Participants Total of all reporting groups
Age, Continuous	55.22 months STANDARD_DEVIATION 32.84 • n=5 Participants	38.14 months STANDARD_DEVIATION 31.35 • n=7 Participants	46.85 months STANDARD_DEVIATION 33.09 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	18 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	31 Participants n=7 Participants	55 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Multiple Electrolyte Solution n=39 Participants multiple electrolyte solution: IV multiple electrolyte solution dosed as clinically indicated for rehydration	Saline n=38 Participants saline: IV saline solution dosed as clinically indicated for rehydration
Change From Baseline of Venous Serum Bicarbonate at 4 Hours From Start of Intravenous (IV)	1.63 mmol/L Standard Deviation 2.54	0.00 mmol/L Standard Deviation 2.25

Adverse Events

Multiple Electrolyte Solution

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Saline

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Multiple Electrolyte Solution n=46 participants at risk multiple electrolyte solution: IV multiple electrolyte solution dosed as clinically indicated for rehydration	Saline n=45 participants at risk saline: IV saline solution dosed as clinically indicated for rehydration
Gastrointestinal disorders Pancreatic enzyme increase	2.2% 1/46 • Number of events 1 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.	0.00% 0/45 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.

Other adverse events

Additional Information

Drew Jones, M.D.

Baxter Healthcare

Phone: 224-270-2659

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Measure	Multiple Electrolyte Solution n=46 participants at risk multiple electrolyte solution: IV multiple electrolyte solution dosed as clinically indicated for rehydration	Saline n=45 participants at risk saline: IV saline solution dosed as clinically indicated for rehydration
Cardiac disorders Tachycardia	2.2% 1/46 • Number of events 1 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.	0.00% 0/45 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.
Gastrointestinal disorders Abdominal pain	2.2% 1/46 • Number of events 1 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.	0.00% 0/45 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.
General disorders Injection site erythema	2.2% 1/46 • Number of events 1 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.	0.00% 0/45 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.
General disorders Injection site extravasation	0.00% 0/46 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.	2.2% 1/45 • Number of events 1 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.
General disorders Injection site swelling	2.2% 1/46 • Number of events 1 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.	0.00% 0/45 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.
General disorders Oedema peripheral	0.00% 0/46 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.	2.2% 1/45 • Number of events 1 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.
General disorders Pyrexia	6.5% 3/46 • Number of events 3 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.	4.4% 2/45 • Number of events 3 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.
Injury, poisoning and procedural complications Contusion	2.2% 1/46 • Number of events 1 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.	0.00% 0/45 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.
Metabolism and nutrition disorders Hyperglycaemia	4.3% 2/46 • Number of events 2 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.	0.00% 0/45 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/46 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.	6.7% 3/45 • Number of events 3 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/46 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.	2.2% 1/45 • Number of events 1 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/46 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.	2.2% 1/45 • Number of events 1 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.
Nervous system disorders Paraesthesia	0.00% 0/46 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.	2.2% 1/45 • Number of events 1 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.
Skin and subcutaneous tissue disorders Dermatitis diaper	2.2% 1/46 • Number of events 1 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.	0.00% 0/45 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.
Skin and subcutaneous tissue disorders Erythema	2.2% 1/46 • Number of events 1 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.	0.00% 0/45 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/46 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.	2.2% 1/45 • Number of events 1 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.
Skin and subcutaneous tissue disorders Rash	2.2% 1/46 • Number of events 1 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.	0.00% 0/45 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/46 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.	2.2% 1/45 • Number of events 1 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.
Vascular disorders Hypotension	2.2% 1/46 • Number of events 1 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.	0.00% 0/45 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.
Investigations Pancreatic Enzymes Increased	2.2% 1/46 • Number of events 1 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.	0.00% 0/45 Treatment emergent SAE and AEs reported on As Treated Population; events starting after the onset of study treatment administration through end of the safety follow-up period.