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NCT05440162
Prevelane and Short Term Outcome of Hypernatremic Dehydration in Children With Acute Gastroenteritis in Sohag University Hospital
trial testing electrolyte in Gastroenteritis Acute in 50 participants. Status unknown.
1 June 2023
Quick facts
| Lead sponsor | Sohag University |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 50 |
| Start date | 1 June 2022 |
| Primary completion | 1 June 2023 |
| Estimated completion | 1 June 2023 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- electrolyte
Conditions studied
- Gastroenteritis Acute — all drugs for Gastroenteritis Acute →
Sponsor
Sohag University
Who can join
Adults 1 Month to 10, any sex, with Gastroenteritis Acute. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05440162 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sohag University
- Last refreshed: 30 June 2022
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