Trial Outcomes & Findings for Two Bag System for Hydration in Diabetes (NCT NCT01631929)
NCT ID: NCT01631929
Last Updated: 2017-02-09
Results Overview
Time needed to achieve patient stabilization defined by: * Plasmatic glucose \< 250 mg/dl * Blood pH \> 7.3 * Plasmatic bicarbonate \> 15 mmol/L
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
Participants were followed for the duration of ketoacidosis (an expected average of 12 hours)
Results posted on
2017-02-09
Participant Flow
Participant milestones
| Measure |
One Bag
IV infusion of fluids, electrolytes and dextrose using one bag
One bag: Infusion of dextrose and electrolytes using one bag
|
Two Bags
Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.
Two bags: Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Two Bag System for Hydration in Diabetes
Baseline characteristics by cohort
| Measure |
One Bag
n=6 Participants
IV infusion of fluids, electrolytes and dextrose using one bag
One bag: Infusion of dextrose and electrolytes using one bag
|
Two Bags
n=6 Participants
Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.
Two bags: Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 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
|
8.83 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
9.67 years
STANDARD_DEVIATION 2.7 • n=7 Participants
|
9.2 years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
|
Gender
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Gender
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Disease debuted
Yes
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Disease debuted
Not
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants were followed for the duration of ketoacidosis (an expected average of 12 hours)Time needed to achieve patient stabilization defined by: * Plasmatic glucose \< 250 mg/dl * Blood pH \> 7.3 * Plasmatic bicarbonate \> 15 mmol/L
Outcome measures
| Measure |
One Bag
n=6 Participants
IV infusion of fluids, electrolytes and dextrose using one bag
One bag: Infusion of dextrose and electrolytes using one bag
|
Two Bags
n=6 Participants
Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.
Two bags: Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.
|
|---|---|---|
|
Time to Achieve Patient Stabilization
|
13.3 Hours
Interval 10.5 to 16.1
|
9.8 Hours
Interval 8.64 to 10.96
|
Adverse Events
One Bag
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Two Bags
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
Ferreira Juan Pablo MD
HOSPITAL GENERAL DE NIÑOS PEDRO DE ELIZALDE
Phone: +5491136085959
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place