GastroenteritisNCT01343758
Study Investigating the Use of Intravenous Fluids With Dextrose for Dehydrated Children
A study testing 5% dextrose in normal saline in people with Gastroenteritis and Dehydration, run by Boston Children's Hospital at 1 site in United States.
Trial summary
Infants and young children often become infected with gastroenteritis leading to vomiting and diarrhea. This can lead to dehydration, one of the most common complaints in the Pediatric Emergency Department. These children are often in need of treatment with intravenous (IV) fluids. Read more about this study
- Who is it for?
- Ages 6 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroenteritis, Dehydration
- What is being tested?
- 5% dextrose in normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jul 2011
- 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 6 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 6 months to 6 years of age
- Gastroenteritis
- Requires IV fluids for dehydration
Who cannot join
- Chronic disease
- Comorbid condition
- Received IV fluids or antiemetics in the last 12 hours
- Symptoms for more than 7 days
- Blood glucose less than 40
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: A Double-blind Randomized Controlled Clinical Trial Investigating the Use of Intravenous Dextrose for Dehydration and Ketosis in Children With Gastroenteritis and Dehydration.
Infants and young children often become infected with gastroenteritis leading to vomiting and diarrhea. This can lead to dehydration, one of the most common complaints in the Pediatric Emergency Department. These children are often in need of treatment with intravenous (IV) fluids. While the investigators know that IV fluids work, it is not clear which type or how much fluid is the best amount to give. Currently, the most common type of IV fluid given is salt water, also called normal saline.
In contrast to adults, infants and young children with dehydration often have a build up of a certain type of acid in their blood which can perpetuate the nausea, vomiting, and general malaise associated with gastroenteritis. The investigators feel that giving these children IV fluids with lots of sugar (in addition to the salt) reduces the acid more rapidly than giving just salt water alone. In a prior study, the investigators have shown that children who receive lower amounts of sugar in the IV fluids return to the Emergency Department more often for a second visit. Based on this study, the investigators believe that children who receive the sugar-salt solution will do better than children who receive just normal saline.
The investigators will determine if the sugar-salt solution is better by giving equal numbers of children the sugar-salt solution and normal saline and then see what happens to each child. The investigators will monitor who needs to be admitted, how much each child vomits, how much each child drinks, and also the level of acid in the blood before and after getting the IV fluid. After the study is completed, the investigators can compare the two different groups (children who received the sugar-salt solution versus children who received normal saline alone) to determine if one group had greater improvement and better clinical outcome than the other.
- Conditions
- Gastroenteritis, Dehydration
- Being tested
- 5% dextrose in normal saline
- Medical subject headings
- Gastroenteritis, Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% dextrose in normal salineOther
Subjects will be randomized to receive a intravenous fluid bolus of 5% dextrose in normal saline or normal saline
| Study group | Role | What they receive |
|---|---|---|
| 5% dextrose in normal saline | Active comparator | This group will receive a bolus of normal saline that contains 5% dextrose Receives: Other: 5% dextrose in normal saline |
| Normal Saline Bolus | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Admission Rate
The investigators will measure what percentage of patients in each treatment group are admitted.
Measured: During emergency department visit
Secondary outcomes (1)
Change in Serum Ketones
The investigators will measure the change in serum ketones at 1 and 2 hours after the study fluid is given and compare the mean change in each treatment group.
Measured: 1 and 2 hours after treatment given
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startJan 2007
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroenteritisStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Investigators
- Jason A Levy, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343758
- Sponsor's protocol ID
- 05-11-153
- Status last verified
- Feb 2012
- First submitted
- 27 Apr 2011
- Last updated
- 24 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomized Controlled Clinical Trial Investigating the Use of Intravenous Dextrose for Dehydration and Ketosis in Children With Gastroenteritis and Dehydration.
- ClinicalTrials.gov ID
- NCT01343758
- Acronym / sponsor ID
- 05-11-153
- Conditions
- Gastroenteritis, Dehydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Jan 2007
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 28 Apr 2011 (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.
Infants and young children often become infected with gastroenteritis leading to vomiting and diarrhea. This can lead to dehydration, one of the most common complaints in the Pediatric Emergency Department. These children are often in need of treatment with intravenous (IV) fluids. While the investigators know that IV fluids work, it is not clear which type or how much fluid is the best amount to give. Currently, the most common type of IV fluid given is salt water, also called normal saline.
In contrast to adults, infants and young children with dehydration often have a build up of a certain type of acid in their blood which can perpetuate the nausea, vomiting, and general malaise associated with gastroenteritis. The investigators feel that giving these children IV fluids with lots of sugar (in addition to the salt) reduces the acid more rapidly than giving just salt water alone. In a prior study, the investigators have shown that children who receive lower amounts of sugar in the IV fluids return to the Emergency Department more often for a second visit. Based on this study, the investigators believe that children who receive the sugar-salt solution will do better than children who receive just normal saline.
The investigators will determine if the sugar-salt solution is better by giving equal numbers of children the sugar-salt solution and normal saline and then see what happens to each child. The investigators will monitor who needs to be admitted, how much each child vomits, how much each child drinks, and also the level of acid in the blood before and after getting the IV fluid. After the study is completed, the investigators can compare the two different groups (children who received the sugar-salt solution versus children who received normal saline alone) to determine if one group had greater improvement and better clinical outcome than the other.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5% dextrose in normal saline | Active comparator | Other: 5% dextrose in normal salineThis group will receive a bolus of normal saline that contains 5% dextrose |
| Normal Saline Bolus | No intervention | – |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 6 months to 6 years of age
- Gastroenteritis
- Requires IV fluids for dehydration
Key exclusion criteria (5 listed)
- Chronic disease
- Comorbid condition
- Received IV fluids or antiemetics in the last 12 hours
- Symptoms for more than 7 days
- Blood glucose less than 40
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 |
|---|---|---|
| 5% dextrose in normal salineSubjects will be randomized to receive a intravenous fluid bolus of 5% dextrose in normal saline or normal saline | Other | 5% dextrose in normal saline |
Primary outcome
Admission Rate
Time frame: During emergency department visit
The investigators will measure what percentage of patients in each treatment group are admitted.
1 secondary outcome
Change in Serum Ketones
Time frame: 1 and 2 hours after treatment given
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 24 Feb 2012.
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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.
Jason A Levy, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5% dextrose in normal saline in people with Gastroenteritis and Dehydration, run by Boston Children's Hospital 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 5 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 24 Feb 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?
Admission Rate (time frame: During emergency department visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2012.