DehydrationNCT02054585
IV NaCl (Sodium Chloride) 0.9% Vs (Versus) IV NaCl 0.9% + 5% Dextrose in Pediatric ER for Dehydration
A study testing NaCl 0.9% and NaCl 0.9 +5% dextrose in people with Dehydration, run by Carmel Medical Center at 1 site in Israel.
Trial summary
Dehydration and refusal to eat and drink are common complaints in the Pediatric ED (Emergency Department). Most of these children have had an unsuccessful trial of oral rehydration in their community service, therefore are treated with IV rehydration. Read more about this study
- Who is it for?
- Ages 6 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration
- What is being tested?
- NaCl 0.9% and NaCl 0.9 +5% dextrose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Jul 2014to Aug 2019
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- children aged 6 month to 18 years suffering dehydration according to clinical criteria who are unable to drink or are vomiting with or without diarrhea who's parents signed an informed consent form.
- clinical criteria for dehydration: elevated heart rate (according to age normal values), reduced urine output, dry mucosa. In children younger than 2 years old also: sunken ayes, sunken fontanels, tearless crying, reduced turgor.
Who cannot join
- children who's first blood glucose measure is below 60 mg/dl
- children who's first blood glucose measure is above 180 mg/dl
- children with metabolic or neurologic disease as a cause of vomiting
- children who need to be hospitalizes for surgery or IV antibiotics
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Carmel Medical Center
Haifa, 34362
Rosana Sh Blejter Palti, MD
About this study
Official title: Intravenous Fluids With or Without Dextrose as Treatment for Dehydration in Children. What's the Formula That Will Bring to a Faster Improvement? A Prospective Randomized Double Blinded Study.
Dehydration and refusal to eat and drink are common complaints in the Pediatric ED (Emergency Department). Most of these children have had an unsuccessful trial of oral rehydration in their community service, therefore are treated with IV rehydration. There is no consensus as to which IV solution is the best one for rehydration. Children who are unwilling or unable to eat and drink produce Keto bodies. Theoretically, addition of glucose to the IV solution would prevent catabolic metabolism and reduce the keto bodies blood concentration which should lead to a faster objective and subjective improvement of the child's condition.
The proposed study is a double blind randomized clinical trial. Children will receive either NaCl 0.9% or NaCl 0.9% + 5% glucose randomly in numbered bags. The type of solution will be known to the pharmacy only.
Read more
Study aims:
- Primary aim: to compare the number of hospitalizations among dehydrated pediatric patients treated with either one of the IV fluids mentioned above.
- Secondary aim: To evaluate for the possibility of hypoglycemia secondary to hyperinsulinism as a response to a rapid administration of glucose.
Study population: The study will include 700 children 6 month to 18 years of age. It will be conducted over 18 months in the Pediatric ED of Carmel Medical Center.
Currently, data regarding the use of dextrose containing solutions is lacking. As dehydration is one of the most common medical problems encountered by the physician in the pediatric ED, it is of outmost importance to evaluate the optimal IV solution used in this setting.
Read the detailed description
This is a prospective randomized double blind study. 700 children 6 months to 18 years of age who are dehydrated and are unable to drink and who's parents sign an informed consent form will participate in this study (see inclusion and exclusion criteria). Our pharmacy department will prepare identical bags half of which will contain NaCl 0.9% and the other half NaCl 0.9% + 5% dextrose. The bags will be randomly numbered using SAS (Statistical analysis system). Only the pharmacy department will know the content of each bag. The children will receive a bolus of 20 mL/Kg of IV fluid. A repeat bolus will be given according to clinical decision from the same bag. A blood glucose level will be taken 2 hours after initiation of the study with a glucometer in order to ascertain that no hypoglycemia is occurring secondary to hyperinsulinism because of fast glucose administration. A urine test in order to check the presence of ketones will also be done. The end point of this study is the moment the physician decides whether to hospitalize or to release the patient from the ER. On the day following his visit to the emergency department, parents will be asked to answer a questionnaire about the child's well being. The questionnaire will be completed in the hospital if the child was admitted or by telephone if the child was discharged.
In addition to the inclusion and exclusion criteria, children in whom an IV catheter could not be introduced, children who's blood glucose after 2 hours of fluid IV administration is below 60 mg/dl or in whom a need for IV antibiotics or surgical intervention will be decided during the ER stay will be taken out of the study.
The data will be analyzed using PASW (predictive analysis software) statistics.
Chi square will be used in order to check statistically significant differences between both groups.
- Conditions
- Dehydration
- Being tested
- NaCl 0.9%, NaCl 0.9 +5% dextrose
- Keywords
- dehydration, pediatric, glucose, IV fluid
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaCl 0.9%Other
Children will be included in each group in a randomized way using SAS (Statistical Analysis System) program.
Intervention: In this arm children will receive 20 ml/kg bolus of IV NaCl 0.9% The bags will be identical and the content will be 1 liter. This way if a second bolus is administrated before hospitalization or discharge is decided, the child will still receive the same fluid.
NaCl 0.9 +5% dextroseOther
Children will be included in each group in a randomized way using SAS (Statistical Analysis System) program.
Intervention: In this arm children will receive 20 ml/kg bolus of IV NaCl 0.9% + 5% dextrose. The bags will be identical and the content will be 1 liter. This way if a second bolus is administrated before hospitalization or discharge is decided, the child will still receive the same fluid.
| Study group | Role | What they receive |
|---|---|---|
| NaCl %0.9 | Active comparator | Children will be included in each group in a randomized way using SAS (Statistical Analysis System) program.
Intervention: In this arm children will receive 20 ml/kg bolus of IV NaCl 0.9% The bags will be identical and the content will be 1 liter. This way if a second bolus is administrated before hospitalization or discharge is decided, the child will still receive the same fluid. Receives: Other: NaCl 0.9% |
| NaCl 0.9% +5% dextrose | Experimental | Children will be included in each group in a randomized way using SAS program.
Intervention: In this arm children will receive 20 ml/kg bolus of IV NaCl 0.9% + 5% glucose. The bags will be identical and the content will be 1 liter. This way if a second bolus is administrated before hospitalization or discharge is decided, the child will still receive the same fluid. Receives: Other: NaCl 0.9 +5% dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
hospitalization
Primary aim: to compare the number of hospitalizations among dehydrated pediatric patients treated with NaCl 0.9% VS NaCl 0.9% + 5% dextrose
Measured: 24 h
Secondary outcomes (1)
hypoglycemia
To evaluate for the possibility of hypoglycemia secondary to hyperinsulinism as a response to a fast administration of glucose.
Measured: 2hs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study start15 Jul 2014
- Primary completionAug 2018 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies of the same condition, open and under way.
- 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
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosana Blejter Palti, Carmel Medical Center
- Investigators
- Rosana Sh Blejter Palti, MD, Principal investigator, Catmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054585
- Sponsor's protocol ID
- CMC-13-0078-CTIL
- Status last verified
- Feb 2017
- First submitted
- 2 Feb 2014
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: after finishing collecting data from 700 patient data will be published analysing groups and not individuals
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Fluids With or Without Dextrose as Treatment for Dehydration in Children. What's the Formula That Will Bring to a Faster Improvement? A Prospective Randomized Double Blinded Study.
- ClinicalTrials.gov ID
- NCT02054585
- Acronym / sponsor ID
- CMC-13-0078-CTIL
- Conditions
- Dehydration
- Keywords
- dehydration, pediatric, glucose, IV fluid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- 15 Jul 2014
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 4 Feb 2014 (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.
Dehydration and refusal to eat and drink are common complaints in the Pediatric ED (Emergency Department). Most of these children have had an unsuccessful trial of oral rehydration in their community service, therefore are treated with IV rehydration. There is no consensus as to which IV solution is the best one for rehydration. Children who are unwilling or unable to eat and drink produce Keto bodies. Theoretically, addition of glucose to the IV solution would prevent catabolic metabolism and reduce the keto bodies blood concentration which should lead to a faster objective and subjective improvement of the child's condition.
The proposed study is a double blind randomized clinical trial. Children will receive either NaCl 0.9% or NaCl 0.9% + 5% glucose randomly in numbered bags. The type of solution will be known to the pharmacy only.
Study aims:
- Primary aim: to compare the number of hospitalizations among dehydrated pediatric patients treated with either one of the IV fluids mentioned above.
- Secondary aim: To evaluate for the possibility of hypoglycemia secondary to hyperinsulinism as a response to a rapid administration of glucose.
Study population: The study will include 700 children 6 month to 18 years of age. It will be conducted over 18 months in the Pediatric ED of Carmel Medical Center.
Currently, data regarding the use of dextrose containing solutions is lacking. As dehydration is one of the most common medical problems encountered by the physician in the pediatric ED, it is of outmost importance to evaluate the optimal IV solution used in this setting.
Detailed description
This is a prospective randomized double blind study. 700 children 6 months to 18 years of age who are dehydrated and are unable to drink and who's parents sign an informed consent form will participate in this study (see inclusion and exclusion criteria). Our pharmacy department will prepare identical bags half of which will contain NaCl 0.9% and the other half NaCl 0.9% + 5% dextrose. The bags will be randomly numbered using SAS (Statistical analysis system). Only the pharmacy department will know the content of each bag. The children will receive a bolus of 20 mL/Kg of IV fluid. A repeat bolus will be given according to clinical decision from the same bag. A blood glucose level will be taken 2 hours after initiation of the study with a glucometer in order to ascertain that no hypoglycemia is occurring secondary to hyperinsulinism because of fast glucose administration. A urine test in order to check the presence of ketones will also be done. The end point of this study is the moment the physician decides whether to hospitalize or to release the patient from the ER. On the day following his visit to the emergency department, parents will be asked to answer a questionnaire about the child's well being. The questionnaire will be completed in the hospital if the child was admitted or by telephone if the child was discharged.
In addition to the inclusion and exclusion criteria, children in whom an IV catheter could not be introduced, children who's blood glucose after 2 hours of fluid IV administration is below 60 mg/dl or in whom a need for IV antibiotics or surgical intervention will be decided during the ER stay will be taken out of the study.
The data will be analyzed using PASW (predictive analysis software) statistics.
Chi square will be used in order to check statistically significant differences between both groups.
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 |
|---|---|---|
| NaCl %0.9 | Active comparator | Other: NaCl 0.9%Children will be included in each group in a randomized way using SAS (Statistical Analysis System) program. Intervention: In this arm children will receive 20 ml/kg bolus of IV NaCl 0.9% The bags will be identical and the content will be 1 liter. This way if a second bolus is administrated before hospitalization or discharge is decided, the child will still receive the same fluid. |
| NaCl 0.9% +5% dextrose | Experimental | Other: NaCl 0.9 +5% dextroseChildren will be included in each group in a randomized way using SAS program. Intervention: In this arm children will receive 20 ml/kg bolus of IV NaCl 0.9% + 5% glucose. The bags will be identical and the content will be 1 liter. This way if a second bolus is administrated before hospitalization or discharge is decided, the child will still receive the same fluid. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- children aged 6 month to 18 years suffering dehydration according to clinical criteria who are unable to drink or are vomiting with or without diarrhea who's parents signed an informed consent form.
- clinical criteria for dehydration: elevated heart rate (according to age normal values), reduced urine output, dry mucosa. In children younger than 2 years old also: sunken ayes, sunken fontanels, tearless crying, reduced turgor.
Key exclusion criteria (4 listed)
- children who's first blood glucose measure is below 60 mg/dl
- children who's first blood glucose measure is above 180 mg/dl
- children with metabolic or neurologic disease as a cause of vomiting
- children who need to be hospitalizes for surgery or IV antibiotics
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 |
|---|---|---|
| NaCl 0.9%Children will be included in each group in a randomized way using SAS (Statistical Analysis System) program. Intervention: In this arm children will receive 20 ml/kg bolus of IV NaCl 0.9% The bags will be identical and the content will be 1 liter. This way if a second bolus is administrated before hospitalization or discharge is decided, the child will still receive the same fluid. | Other | NaCl %0.9 |
| NaCl 0.9 +5% dextroseChildren will be included in each group in a randomized way using SAS (Statistical Analysis System) program. Intervention: In this arm children will receive 20 ml/kg bolus of IV NaCl 0.9% + 5% dextrose. The bags will be identical and the content will be 1 liter. This way if a second bolus is administrated before hospitalization or discharge is decided, the child will still receive the same fluid. | Other | NaCl 0.9% +5% dextrose |
Primary outcome
hospitalization
Time frame: 24 h
Primary aim: to compare the number of hospitalizations among dehydrated pediatric patients treated with NaCl 0.9% VS NaCl 0.9% + 5% dextrose
1 secondary outcome
hypoglycemia
Time frame: 2hs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Individual participant dataSharing planned: No. after finishing collecting data from 700 patient data will be published analysing groups and not individuals
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Hypernatremia Fluid Therapy in Childhood Diarrhoea
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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.
Rosana Sh Blejter Palti, MD principal investigator
Catmel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NaCl 0.9% and NaCl 0.9 +5% dextrose in people with Dehydration, run by Carmel Medical Center at 1 site in Israel.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 Feb 2017. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rosana Sh Blejter Palti, MD (00972546365444, rosiblejter@yahoo.com.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hospitalization (time frame: 24 h). 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 10 Feb 2017.