DiabetesNCT01701557
Fluid Resuscitation for Pediatric Diabetic Ketoacidosis
A study testing slow fluid rate and fast fluid rate in people with Diabetes, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Randomized trial to determine if the volume of fluid administration in pediatric patients with DKA impacts the rate of normalization of serum bicarbonate, pH as well as the length of treatment Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Diabetes
- What is being tested?
- slow fluid rate and fast fluid rate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1 day to 18 years of age
- type 1 diabetes
- presence of DKA, as defined by glucose >250 mg/dl, accumulation of ketone bodies in the blood, and metabolic acidosis (venous pH < 7.30 or serum bicarbonate < 15 mmol/L.)
Who cannot join
- requirement for additional fluid resuscitation for hemodynamic instability
- weight greater than 70 kilograms
Trial locations and contacts
1 site in 1 country.
United States1 site
the Childrens Hospital Colorado
Aurora, Colorado, 80045
About this study
Randomized trial to determine if the volume of fluid administration in pediatric patients with DKA impacts the rate of normalization of serum bicarbonate, pH as well as the length of treatment
Read the detailed description
A randomized trial of two initial volumes of IVF and subsequent administration rates. Group I received 10 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.25 times maintenance and Group II received 20 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.5 times maintenance. The specific variables measured included demographics (age, gender, and race/ethnicity) and routine laboratory values (pH, pCO2, plasma glucose, electrolytes, bicarbonate, sodium, chloride, BUN. Length of treatment was defined as a time of the hospital stay after the start of IVF infusion.
- Conditions
- Diabetes
- Being tested
- slow fluid rate, fast fluid rate
- Keywords
- Ketoacidosis Fluids
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
slow fluid rateOther
Also called normal saline
10 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.25 times maintenance
fast fluid rateOther
Also called normal saline
20 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.5 times maintenance
| Study group | Role | What they receive |
|---|---|---|
| slow fluid rate | Active comparator | bolus 10 ml/kg of NS followed by 1.25 times maintenance rate Receives: Other: slow fluid rate |
| Fast fluid rate | Active comparator | bolus 20 ml/kg of NS followed by 1.5 times maintenance rate Receives: Other: fast fluid rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to normalization of bicarbonate and pH
Laboratory parameters were measured hourly for the first 4 hours, and every 2 to3 hours thereafter until acid-base normalization (pH was above 7.3 or the HCO3 was above 15 mmol/L)
Measured: start of treatment until resolution of DKA an expected average of 12 to 24 hours
Secondary outcomes (1)
the length of treatment
Length of treatment was defined as a time of the hospital stay after the start of IVF infusion
Measured: discharge from the hospital, an expected average of 1-2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startNov 2007
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arleta Rewers, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701557
- Sponsor's protocol ID
- 06-0846
- Status last verified
- Oct 2012
- First submitted
- 1 Oct 2012
- Last updated
- 5 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Bakes K, Haukoos JS, Deakyne SJ, Hopkins E, Easter J, McFann K, Brent A, Rewers A. Effect of Volume of Fluid Resuscitation on Metabolic Normalization in Children Presenting in Diabetic Ketoacidosis: A Randomized Controlled Trial. J Emerg Med. 2016 Apr;50(4):551-9. doi: 10.1016/j.jemermed.2015.12.003. Epub 2016 Jan 25.
PubMed 26823137
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Resuscitation for Pediatric Diabetic Ketoacidosis
- ClinicalTrials.gov ID
- NCT01701557
- Acronym / sponsor ID
- 06-0846
- Conditions
- Diabetes
- Keywords
- Ketoacidosis Fluids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 5 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized trial to determine if the volume of fluid administration in pediatric patients with DKA impacts the rate of normalization of serum bicarbonate, pH as well as the length of treatment
Detailed description
A randomized trial of two initial volumes of IVF and subsequent administration rates. Group I received 10 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.25 times maintenance and Group II received 20 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.5 times maintenance. The specific variables measured included demographics (age, gender, and race/ethnicity) and routine laboratory values (pH, pCO2, plasma glucose, electrolytes, bicarbonate, sodium, chloride, BUN. Length of treatment was defined as a time of the hospital stay after the start of IVF infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| slow fluid rate | Active comparator | Other: slow fluid ratebolus 10 ml/kg of NS followed by 1.25 times maintenance rate |
| Fast fluid rate | Active comparator | Other: fast fluid ratebolus 20 ml/kg of NS followed by 1.5 times maintenance rate |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 1 day to 18 years of age
- type 1 diabetes
- presence of DKA, as defined by glucose >250 mg/dl, accumulation of ketone bodies in the blood, and metabolic acidosis (venous pH < 7.30 or serum bicarbonate < 15 mmol/L.)
Key exclusion criteria (2 listed)
- requirement for additional fluid resuscitation for hemodynamic instability
- weight greater than 70 kilograms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| slow fluid rateAlso: normal saline10 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.25 times maintenance | Other | slow fluid rate |
| fast fluid rateAlso: normal saline20 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.5 times maintenance | Other | Fast fluid rate |
Primary outcome
time to normalization of bicarbonate and pH
Time frame: start of treatment until resolution of DKA an expected average of 12 to 24 hours
Laboratory parameters were measured hourly for the first 4 hours, and every 2 to3 hours thereafter until acid-base normalization (pH was above 7.3 or the HCO3 was above 15 mmol/L)
1 secondary outcome
the length of treatment
Time frame: discharge from the hospital, an expected average of 1-2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2012.
- Derived from this study: PubMed 26823137Bakes K, Haukoos JS, Deakyne SJ, Hopkins E, Easter J, McFann K, Brent A, Rewers A. Effect of Volume of Fluid Resuscitation on Metabolic Normalization in Children Presenting in Diabetic Ketoacidosis: A Randomized Controlled Trial. J Emerg Med. 2016 Apr;50(4):551-9. doi: 10.1016/j.jemermed.2015.12.003. Epub 2016 Jan 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arleta Rewers, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing slow fluid rate and fast fluid rate in people with Diabetes, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to normalization of bicarbonate and pH (time frame: start of treatment until resolution of DKA an expected average of 12 to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01701557, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2012.