Gastroenteritis AcuteNCT05440162
Prevelane and Short Term Outcome of Hypernatremic Dehydration in Children With Acute Gastroenteritis in Sohag University Hospital
An observational study of Gastroenteritis Acute, run by Sohag University at 1 site in Egypt.
Trial summary
Hypernatremic dehydration (HND) is a common and potentially life-threatening condition in children. It is defined by a serum level of sodium greater than or equal to 145 mmol/L . HND is a type of acute dehydration constitutes a medical emergency and requires a rapid diagnosis for adequate and quick management. Read more about this study
- Who is it for?
- Ages 1 month to 10 years
- Conditions the study is for
- Gastroenteritis Acute
- What is being tested?
- electrolyte
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 1 Jun 2023
- Phase
- Observational
- 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 month to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: will be taken from patients' parents or their caregivers including onset, course and duration of gastroenteritis; frequency, volume, consistency and contents of diarrhea; frequency, volume and contents of vomiting and manifestations of dehydration. Detailed clinical examination will be done with stress on signs of shock and dehydration including looking for thirsty, irritability, pinched look, sunken eyes, dry inner side of cheeks, abdominal distention, deep and rapid breathing, weak and thready pulse, falling blood pressure, reduced quantity of urine according to WHO dehydration assessment scale.
Who may be able to join
- Children with acute gastroenteritis who fulfill the following criteria:
- Age from one month up to 10 years.
- Large frequent stools.
- Symptoms and signs of dehydration.
- Serum sodium level ≧ 145 mmol/L.
Who cannot join
- Parenteral diarrhea.
- Gastroenteritis more than 14 days
Trial locations and contacts
1 site in 1 country.
ashraf A redwan, assisstant professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Osama R Elshrif, professor
About this study
Hypernatremic dehydration (HND) is a common and potentially life-threatening condition in children. It is defined by a serum level of sodium greater than or equal to 145 mmol/L . HND is a type of acute dehydration constitutes a medical emergency and requires a rapid diagnosis for adequate and quick management. It is characterized by a deficit of total body water (TBW) relative to total body sodium (TBS) levels due to either loss of free water, or excessive administration of hypertonic sodium solutions. It is common in infants. Net water loss as seen in diarrhea is the most common cause of hypernatremia. Clinical interventions at the hospital settings or accidental sodium loading usually cause hypertonic sodium gain. It is common in developing countries where gastroenteritis is a common problem.
Most children with hypernatremia are dehydrated and have the typical signs and symptoms as weight loss, decreased skin turgor, pale skin color, and dry mucous membranes. Hypernatremia, even without dehydration, cause central nervous system symptoms according to the degree of sodium elevation and the acuity of the increase. Patients are irritable, restless weak, and lethargic. Some infants have a high-pitched cry. Alert patients are very thirsty, although nausea and fever may be present.
Read more
HND can lead to neurological impairment due to brain shrinkage, which can tear cerebral blood vessels, leading to brain hemorrhage. Cerebral hemorrhages are the most serious complications of HND that can eventually lead to convulsions and even coma .
The first priority in managing a child with HND is to stop the ongoing water loss by treating the underlying cause. The next step is to restore the intravascular volume with isotonic fluid. Dehydration can be treated with oral, nasogastric, or intravenous fluids. The child is given a fluid bolus, usually 20 mL/kg of the isotonic solution, over about 20 to 30 minutes. More severe dehydration needs repeated boluses at a faster rate. After the fluid bolus is given, the signs of dehydration should be reassessed in order to confirm a complete rehydration. Fluid loss should not be corrected rapidly. Cerebral edema as well as convulsions is serious risks during rapid rehydration, so correction of deficit should be achieved slowly and gradually over 48 hours and should not be decreased to less than 12 mEq/L. To prevent cerebral edema and convulsion, individuals with hypernatremia should be managed in such a way that the reduction rate of serum sodium occurs at approximately 10 to 12 mmol/L/24 hr.
Cerebral edema and seizures can be consequences of rapid correction of serum sodium level in these patients in whom the rate of fluid and sodium administration are inappropriate
- Conditions
- Gastroenteritis Acute
- Being tested
- electrolyte
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrolyteDiagnostic test
follow up NA
What is being measured
The primary outcome is the main question the study is designed to answer.
sodium percentage
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start1 Jun 2022
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastroenteritis AcuteStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Ahmed Mostafa, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440162
- Sponsor's protocol ID
- Soh-Med-22-06-08
- Status last verified
- Jun 2022
- First submitted
- 27 Jun 2022
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mujawar NS, Jaiswal AN. Hypernatremia in the Neonate: Neonatal Hypernatremia and Hypernatremic Dehydration in Neonates Receiving Exclusive Breastfeeding. Indian J Crit Care Med. 2017 Jan;21(1):30-33. doi: 10.4103/0972-5229.198323.
PubMed 28197048Arampatzis S, Frauchiger B, Fiedler GM, Leichtle AB, Buhl D, Schwarz C, Funk GC, Zimmermann H, Exadaktylos AK, Lindner G. Characteristics, symptoms, and outcome of severe dysnatremias present on hospital admission. Am J Med. 2012 Nov;125(11):1125.e1-1125.e7. doi: 10.1016/j.amjmed.2012.04.041. Epub 2012 Aug 28.
PubMed 22939097Colletti JE, Brown KM, Sharieff GQ, Barata IA, Ishimine P; ACEP Pediatric Emergency Medicine Committee. The management of children with gastroenteritis and dehydration in the emergency department. J Emerg Med. 2010 Jun;38(5):686-98. doi: 10.1016/j.jemermed.2008.06.015. Epub 2009 Apr 5.
PubMed 19345549Robertson G, Carrihill M, Hatherill M, Waggie Z, Reynolds L, Argent A. Relationship between fluid management, changes in serum sodium and outcome in hypernatraemia associated with gastroenteritis. J Paediatr Child Health. 2007 Apr;43(4):291-6. doi: 10.1111/j.1440-1754.2007.01061.x.
PubMed 17444832
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevelane and Short Term Outcome of Hypernatremic Dehydration in Children With Acute Gastroenteritis in Sohag University Hospital
- ClinicalTrials.gov ID
- NCT05440162
- Acronym / sponsor ID
- Soh-Med-22-06-08
- Conditions
- Gastroenteritis Acute
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 30 Jun 2022 (actual)
- 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.
Hypernatremic dehydration (HND) is a common and potentially life-threatening condition in children. It is defined by a serum level of sodium greater than or equal to 145 mmol/L . HND is a type of acute dehydration constitutes a medical emergency and requires a rapid diagnosis for adequate and quick management. It is characterized by a deficit of total body water (TBW) relative to total body sodium (TBS) levels due to either loss of free water, or excessive administration of hypertonic sodium solutions. It is common in infants. Net water loss as seen in diarrhea is the most common cause of hypernatremia. Clinical interventions at the hospital settings or accidental sodium loading usually cause hypertonic sodium gain. It is common in developing countries where gastroenteritis is a common problem.
Most children with hypernatremia are dehydrated and have the typical signs and symptoms as weight loss, decreased skin turgor, pale skin color, and dry mucous membranes. Hypernatremia, even without dehydration, cause central nervous system symptoms according to the degree of sodium elevation and the acuity of the increase. Patients are irritable, restless weak, and lethargic. Some infants have a high-pitched cry. Alert patients are very thirsty, although nausea and fever may be present.
HND can lead to neurological impairment due to brain shrinkage, which can tear cerebral blood vessels, leading to brain hemorrhage. Cerebral hemorrhages are the most serious complications of HND that can eventually lead to convulsions and even coma .
The first priority in managing a child with HND is to stop the ongoing water loss by treating the underlying cause. The next step is to restore the intravascular volume with isotonic fluid. Dehydration can be treated with oral, nasogastric, or intravenous fluids. The child is given a fluid bolus, usually 20 mL/kg of the isotonic solution, over about 20 to 30 minutes. More severe dehydration needs repeated boluses at a faster rate. After the fluid bolus is given, the signs of dehydration should be reassessed in order to confirm a complete rehydration. Fluid loss should not be corrected rapidly. Cerebral edema as well as convulsions is serious risks during rapid rehydration, so correction of deficit should be achieved slowly and gradually over 48 hours and should not be decreased to less than 12 mEq/L. To prevent cerebral edema and convulsion, individuals with hypernatremia should be managed in such a way that the reduction rate of serum sodium occurs at approximately 10 to 12 mmol/L/24 hr.
Cerebral edema and seizures can be consequences of rapid correction of serum sodium level in these patients in whom the rate of fluid and sodium administration are inappropriate
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- will be taken from patients' parents or their caregivers including onset, course and duration of gastroenteritis; frequency, volume, consistency and contents of diarrhea; frequency, volume and contents of vomiting and manifestations of dehydration. Detailed clinical examination will be done with stress on signs of shock and dehydration including looking for thirsty, irritability, pinched look, sunken eyes, dry inner side of cheeks, abdominal distention, deep and rapid breathing, weak and thready pulse, falling blood pressure, reduced quantity of urine according to WHO dehydration assessment scale.
Key inclusion criteria (5 listed)
- Children with acute gastroenteritis who fulfill the following criteria:
Key exclusion criteria (2 listed)
- Parenteral diarrhea.
- Gastroenteritis more than 14 days
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 |
|---|---|---|
| electrolytefollow up NA | Diagnostic test | – |
Primary outcome
sodium percentage
Time frame: 1year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Background: PubMed 28197048Mujawar NS, Jaiswal AN. Hypernatremia in the Neonate: Neonatal Hypernatremia and Hypernatremic Dehydration in Neonates Receiving Exclusive Breastfeeding. Indian J Crit Care Med. 2017 Jan;21(1):30-33. doi: 10.4103/0972-5229.198323.
- Background: PubMed 22939097Arampatzis S, Frauchiger B, Fiedler GM, Leichtle AB, Buhl D, Schwarz C, Funk GC, Zimmermann H, Exadaktylos AK, Lindner G. Characteristics, symptoms, and outcome of severe dysnatremias present on hospital admission. Am J Med. 2012 Nov;125(11):1125.e1-1125.e7. doi: 10.1016/j.amjmed.2012.04.041. Epub 2012 Aug 28.
- Background: PubMed 19345549Colletti JE, Brown KM, Sharieff GQ, Barata IA, Ishimine P; ACEP Pediatric Emergency Medicine Committee. The management of children with gastroenteritis and dehydration in the emergency department. J Emerg Med. 2010 Jun;38(5):686-98. doi: 10.1016/j.jemermed.2008.06.015. Epub 2009 Apr 5.
- Background: PubMed 17444832Robertson G, Carrihill M, Hatherill M, Waggie Z, Reynolds L, Argent A. Relationship between fluid management, changes in serum sodium and outcome in hypernatraemia associated with gastroenteritis. J Paediatr Child Health. 2007 Apr;43(4):291-6. doi: 10.1111/j.1440-1754.2007.01061.x.
- Individual participant dataSharing planned: Undecided
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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.
ashraf A redwan, assisstant professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroenteritis Acute, run by Sohag University at 1 site in Egypt.
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 5 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: status not confirmed, as of the sponsor's last update on 30 Jun 2022. 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 Egypt. 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 Aya A Mostafa, resident (01060661588, Aya011012@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sodium percentage (time frame: 1year). 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 NCT05440162, which also lists 4 linked publications.
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 30 Jun 2022.