Trial Outcomes & Findings for Double Blinded Randomized Control Trial of Types of IVF in Children With DKA (NCT NCT03066440)
NCT ID: NCT03066440
Last Updated: 2024-08-06
Results Overview
Hours to pH\>7.25 and normal anion gap and serum bicarbonate over 15
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
53 participants
Primary outcome timeframe
28 days
Results posted on
2024-08-06
Participant Flow
Patients were recruited when presenting to a tertiary care free-standing children's hospital in diabetic ketoacidosis from October 2018 to June 2021 when the study was suspended by the facility pharmacy due to a critical shortage of electrolytes for all IVF bags. The study was ended early in March 2024 when the pharmacy informed the study team electrolytes will not be available in a reasonable timeframe.
Upon enrollment, patients were randomized and treated in a double blind design
Participant milestones
| Measure |
Normal Saline (Controls)
Intravenous solutions containing only normal saline as the primary base were given during duration of treatment of diabetic ketoacidosis.
|
Lactated Ringers (Intervention)
Intravenous fluids containing lactated ringer's as the primary base were given during the duration of treatment of pediatric diabetic ketoacidosis.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
27
|
|
Overall Study
COMPLETED
|
25
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Normal Saline (Controls)
Intravenous solutions containing only normal saline as the primary base were given during duration of treatment of diabetic ketoacidosis.
|
Lactated Ringers (Intervention)
Intravenous fluids containing lactated ringer's as the primary base were given during the duration of treatment of pediatric diabetic ketoacidosis.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
2
|
Baseline Characteristics
Double Blinded Randomized Control Trial of Types of IVF in Children With DKA
Baseline characteristics by cohort
| Measure |
Normal Saline
n=25 Participants
All intravenous fluids used in the treatment of pediatric diabetic ketoacidosis will be based in normal saline for control participants
|
Lactated Ringers
n=24 Participants
All intravenous fluids used in the treatment of pediatric diabetic ketoacidosis will be based in lactated ringer's solution for participants in the interventional arm
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
160 Months
n=5 Participants
|
155.5 Months
n=7 Participants
|
158 Months
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
24 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Admission HgbA1C
|
12.9 mmol/mol
n=5 Participants
|
12.8 mmol/mol
n=7 Participants
|
12.8 mmol/mol
n=5 Participants
|
|
New onset Type 1 Diabetes
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysHours to pH\>7.25 and normal anion gap and serum bicarbonate over 15
Outcome measures
| Measure |
Normal Saline (Controls)
n=25 Participants
Intravenous solutions containing only normal saline as the primary base were given during duration of treatment of diabetic ketoacidosis.
|
Lactated Ringers (Intervention)
n=24 Participants
Intravenous fluids containing lactated ringer's as the primary base were given during the duration of treatment of pediatric diabetic ketoacidosis.
|
|---|---|---|
|
Length of Acidosis
|
19.4 Hours
Interval 11.6 to 29.1
|
19.8 Hours
Interval 12.9 to 23.3
|
SECONDARY outcome
Timeframe: 28 daysTime from admission to the emergency room or pediatric intensive care unit and transfer from the pediatric intensive care unit to the general pediatric ward
Outcome measures
| Measure |
Normal Saline (Controls)
n=25 Participants
Intravenous solutions containing only normal saline as the primary base were given during duration of treatment of diabetic ketoacidosis.
|
Lactated Ringers (Intervention)
n=24 Participants
Intravenous fluids containing lactated ringer's as the primary base were given during the duration of treatment of pediatric diabetic ketoacidosis.
|
|---|---|---|
|
Length of Stay in the Pediatric Intensive Care Unit
|
0.97 days
Interval 0.75 to 1.4
|
1.1 days
Interval 0.92 to 1.6
|
SECONDARY outcome
Timeframe: 28 daysTime from admission to the emergency room or pediatric intensive care unit and transfer from the pediatric intensive care unit to discharge home
Outcome measures
| Measure |
Normal Saline (Controls)
n=25 Participants
Intravenous solutions containing only normal saline as the primary base were given during duration of treatment of diabetic ketoacidosis.
|
Lactated Ringers (Intervention)
n=24 Participants
Intravenous fluids containing lactated ringer's as the primary base were given during the duration of treatment of pediatric diabetic ketoacidosis.
|
|---|---|---|
|
Length of Stay in the Hospital
|
1.9 days
Interval 1.2 to 2.3
|
2.0 days
Interval 1.8 to 2.7
|
Adverse Events
Normal Saline (Controls)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lactated Ringers (Intervention)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Normal Saline (Controls)
n=26 participants at risk
Intravenous solutions containing only normal saline as the primary base were given during duration of treatment of diabetic ketoacidosis.
|
Lactated Ringers (Intervention)
n=27 participants at risk
Intravenous fluids containing lactated ringer's as the primary base were given during the duration of treatment of pediatric diabetic ketoacidosis.
|
|---|---|---|
|
Investigations
Improper Consent Obtained
|
0.00%
0/26 • Adverse event data were collected for the entirety of the participants hospital stay, up to 28 days.
|
7.4%
2/27 • Number of events 2 • Adverse event data were collected for the entirety of the participants hospital stay, up to 28 days.
|
Additional Information
Dr. Amanda B. Hassinger, Medical Director of the UBMD Pediatrics Sleep Center
UBMD Pediatrics
Phone: 716-323-0158
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place