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Status unknownNCT05440162Updated Jun 30, 2022

Prevelane and Short Term Outcome of Hypernatremic Dehydration in Children With Acute Gastroenteritis in Sohag University Hospital

An observational study in Gastroenteritis Acute, sponsored by Sohag University. Status unknown at 1 site in Egypt. Open to participants aged 1 Month to 10 Years. Per ClinicalTrials.gov, last updated 2022-06-30.

Sponsored by Sohag University · Observational

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
1 Month to 10 Years
Sex
All
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Study 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. 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

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Conditions studied

  • Gastroenteritis Acute
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In context

Gastroenteritis

243 studies on the registry are indexed under Gastroenteritis; 15 are open to participants now.

This study's planned enrollment of 50 is below the median of 611 across 71 observational studies indexed under Gastroenteritis.

Browse Gastroenteritis studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Month to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • Children with acute gastroenteritis who fulfill the following criteria:

    1. Age from one month up to 10 years.
    2. Large frequent stools.
    3. Symptoms and signs of dehydration.
    4. Serum sodium level ≧ 145 mmol/L.

Exclusion criteria

Exclusion Criteria:

  1. Parenteral diarrhea.
  2. Gastroenteritis more than 14 days
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testelectrolyte

    follow up NA

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What researchers measure

Primary outcomes

  1. sodium percentage

    Time frame: 1year

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Study locations

1 of 1 sites recruiting
  • Sohag University Hospital
    Sohag, Egypt
    • Osama R Elshrif, professor · Contact
    Recruiting
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References and documents

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 28197048 ↗
  • Arampatzis 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 22939097 ↗
  • Colletti 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 19345549 ↗
  • Robertson 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 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05440162
Lead sponsor
Sohag University
Responsible party
Aya Ahmed Mostafa (resident doctor at pediatric department at faculty of medicine sohag university hospital, Sohag University) — Principal investigator
First posted
Jun 30, 2022
Start date
Jun 1, 2022
Primary completion
Jun 1, 2023 (estimated)
Completion
Jun 1, 2023 (estimated)
Last update
Jun 30, 2022

Study contacts

Aya A Mostafa, resident
Contact
Aya011012@med.sohag.edu.eg
01060661588
ashraf A redwan, assisstant professor
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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