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Trial Outcomes & Findings for IV Glucose for Dehydration Treatment (NCT NCT01285713)

NCT ID: NCT01285713

Last Updated: 2019-03-19

Results Overview

Measurement of serum ketones by bedside ketone meter before and after administration of IVF for both groups to determine a change in serum ketones. The hypothesis is that dextrose containing IVF will lead to a decrease in serum ketones in children with acute gastroenteritis who require IV rehydration.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

83 participants

Primary outcome timeframe

4 hours

Results posted on

2019-03-19

Participant Flow

Participant milestones

Participant milestones
Measure
5% Dextrose (D5) in Normal Saline (NS)
10cc/kg 5% Dextrose (D5) in Normal Saline (NS) (D5NS), followed by 30cc/kg Normal Saline (NS)
Normal Saline (NS)
10cc/kg NS, followed by 30cc/kg NS
Overall Study
STARTED
42
41
Overall Study
COMPLETED
42
41
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

IV Glucose for Dehydration Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
D5Normal Saline
n=42 Participants
10cc/kg D5NS, followed by 30cc/kg NS
Normal Saline
n=41 Participants
10cc/kg NS, followed by 30cc/kg NS
Total
n=83 Participants
Total of all reporting groups
Age, Categorical
<=18 years
42 Participants
n=5 Participants
41 Participants
n=7 Participants
83 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
3.6 years
STANDARD_DEVIATION 3.3 • n=5 Participants
3.4 years
STANDARD_DEVIATION 3.0 • n=7 Participants
3.5 years
STANDARD_DEVIATION 3.1 • n=5 Participants
Sex: Female, Male
Female
22 Participants
n=5 Participants
24 Participants
n=7 Participants
46 Participants
n=5 Participants
Sex: Female, Male
Male
20 Participants
n=5 Participants
17 Participants
n=7 Participants
37 Participants
n=5 Participants
Region of Enrollment
United States
42 participants
n=5 Participants
41 participants
n=7 Participants
83 participants
n=5 Participants

PRIMARY outcome

Timeframe: 4 hours

Measurement of serum ketones by bedside ketone meter before and after administration of IVF for both groups to determine a change in serum ketones. The hypothesis is that dextrose containing IVF will lead to a decrease in serum ketones in children with acute gastroenteritis who require IV rehydration.

Outcome measures

Outcome measures
Measure
D5Normal Saline
n=33 Participants
10cc/kg D5NS, followed by 30cc/kg NS
Normal Saline
n=36 Participants
10cc/kg NS, followed by 30cc/kg NS
Measurement of Serum Ketones Before and After Administration of Intravenous Fluids for Acute Gastroenteritis
1.10 mmol/L
Standard Deviation 1.20
2.39 mmol/L
Standard Deviation 1.62

Adverse Events

D5Normal Saline

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Normal Saline

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kari Posner

New York University, Langone Medical Center

Phone: 212-263-7300

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place