Hypernatremia Fluid Therapy in Childhood Diarrhoea

NCT07884747 | Enrolling By Invitation DMC

• 1 other identifier: PR 25040
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

Brief Summary

Hypernatremic dehydration is a life-threatening condition, particularly in children under two years of age, with mortality rates reaching up to as high as 19%. Infants are highly susceptible due to immature renal function, increased insensible water loss, and limited ability to express thirst. Severe hypernatremia can cause cerebral complications such as brain shrinkage, haemorrhage, seizures, paralysis, and encephalopathy. Furthermore, rapid or improperly managed fluid and electrolyte treatment can increase the risk of cerebral oedema and death. Although gradual sodium correction is widely recommended for hypernatremia, the optimal rate, route, and type of fluid therapy remain uncertain. Current treatment practices vary and no standardized protocol has been validated in randomized clinical trials for young children. This gap contributes to persistently high mortality and neurological morbidity. The goal of this clinical trial is to determine whether oral rehydration therapy is non-inferior to intravenous fluid therapy in the management of hypernatremic dehydration among children under five years of age with diarrhoea. The main questions it aims to answer are: Does oral rehydration therapy result in mortality rates comparable to those of intravenous fluid therapy among children with hypernatremic dehydration? Does oral rehydration therapy achieve safe correction of serum sodium levels and comparable neurological and clinical outcomes relative to intravenous fluid therapy? Researchers will compare oral rehydration therapy using oral rehydration salt (ORS) solution with intravenous fluid therapy using half-strength acetate in 5% dextrose to determine whether oral therapy is non-inferior to intravenous therapy in reducing mortality and improving clinical outcomes. Total 268 participants will: Be randomly assigned to 1:1 to receive either oral rehydration therapy or intravenous fluid therapy. Receive standardized fluid volumes calculated according to paediatric treatment protocols. Undergo clinical assessments and laboratory investigations, including serial serum sodium measurements, during hospitalization. Be monitored for adverse outcomes, including convulsions, fluid overload, and renal impairment. Have neurological status assessed using the Glasgow Coma Scale (GCS) on admission and at discharge. Attend follow-up assessments at 1 month and 6 months after discharge for neurodevelopmental evaluation using the Denver Developmental Screening Test II.

Conditions

Hypernatremia; Acute Watery Diarrhea

Keywords

Hypernatremia: Oral versus intravenous fluid therapy in pediatric dehydration

Outcome Measures

Primary Outcomes (1)

• All-cause mortality from initiation of the intervention until hospital discharge among children under five years of age with hypernatremic dehydration associated with diarrhoea.

  Events of death any time during hospitalization after initiation of intervention until discharge.

  From enrollment to discharge (approximately 7 days)

Secondary Outcomes (5)

• Incidence of rapid serum-sodium (>12 mmol/L in 24 hours)

  From enrollment to the normalization of sodium level (Approximately 3 days from enrollment)

• Need for ancillary interventions (e.g., 3% NaCl, anticonvulsants)

  From enrollment to discharge (approximately 7 days)

• Acute kidney injury (AKI) events

  From enrollment to the normalization of both sodium and creatinine level (Approximately 3 days from enrollment)

• Poor neurological outcome at month 1 and month 6

  After treatment complete to end of follow up at month 6

• The case fatality at 6-month follow-up

  After discharge o end of follow up at month 6

Study Arms (2)

Intravenous Fluid Therapy

ACTIVE COMPARATOR

Participants in the IV arm will receive 0.5% acetate in 5% dextrose at a total fluid volume of 1.5 times the maintenance requirement, administered over 24-84 hours depending on the severity of hypernatremia. If the baseline serum potassium level is above the normal range, 0.45% normal saline in 5% dextrose will be used instead of the acetate-containing solution

Drug: Oral rehydration solution (ORS)

Oral Fluid Therapy

ACTIVE COMPARATOR

Participants in the oral arm will receive low-osmolarity oral rehydration solution (ORS) as the sole fluid therapy. The total fluid volume will be 1.5 times the maintenance requirement, administered over 24-84 hours, depending on the severity of hypernatremia.

Drug: Oral rehydration solution (ORS)

Interventions

Oral rehydration solution (ORS) DRUG

For participants of oral arm, the study will use a standardized protocol that matches the same fluid volume calculated via the same formula but will be administered via oral or nasogastric routes. The study will use commercially available WHO recommended low osmolality ORS. The oral regimen follows the same sodium correction targets as the intravenous arm.

Intravenous Fluid Therapy; Oral Fluid Therapy

Eligibility Criteria

• Age: 1 Day - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children of either sex with diarrhoea
• Children with serum sodium concentration ≥150 mmol/L with or without symptoms
• Parent(s) provide informed written consent for the child's participation in the study

You may not qualify if:

• Children with any congenital anomaly or features suggestive of any syndrome
• Critically ill children (e.g., septic shock, multi-organ failure) requiring inotrope or mechanical ventilation
• Children with features of heart failure, ileus, or oedematous malnutrition
• Any children with baseline creatinine \>5 times normal

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (1)

Icddrb

Dhaka, Dhaka Division, 1212, Bangladesh

Location

Related Publications (18)

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• Didsbury M, See EJ, Cheng DR, Kausman J, Quinlan C. Correcting Hypernatremia in Children. Clin J Am Soc Nephrol. 2023 Mar 1;18(3):306-314. doi: 10.2215/CJN.0000000000000077.

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  BACKGROUND

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  BACKGROUND

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• Shireen A, Tahmina F, Farhana Y, Umme T, Sukriti B, Hossain MK. Management of severe hypernatremic dehydration and acute kidney injury in children in a critical care nephrology and dialysis unit. Saudi J Kidney Dis Transpl. 2021 Sep-Oct;32(5):1431-1440. doi: 10.4103/1319-2442.344764.

  PMID: 35532714 BACKGROUND

• Lindner G, Funk GC, Schwarz C, Kneidinger N, Kaider A, Schneeweiss B, Kramer L, Druml W. Hypernatremia in the critically ill is an independent risk factor for mortality. Am J Kidney Dis. 2007 Dec;50(6):952-7. doi: 10.1053/j.ajkd.2007.08.016.

  PMID: 18037096 BACKGROUND

• Hameed R, Babar H, Bizenjo A, Rayaz S, Iqbal M, Abdullah H. Frequency of Hypernatremia Among Children Below 2 Years Presenting with Acute Gastroenteritis. Indus Journal of Bioscience Research. 2025;3(5):439-42.DOI: https://doi.org/10.70749/ijbr.v3i5.1390

  BACKGROUND

• Shankar P, Mahamud S, Aara A. Study of electrolyte disturbances and renal parameters in acute gastroenteritis under 5 years of age in a tertiary care hospital of Bengaluru, India. Int J Contemp Pediatr. 2020;7(9):1531-36.DOI: https://doi.org/10.18203/2349-3291.ijcp20203654

  BACKGROUND

• Chakravarthi G, Kumar RP. Study on incidences of electrolyte disorders among children with dehydration. Pediatr Rev. 2019;6(352):e8. DOI: https://doi.org/10.17511/ijpr.2019.i07.07

  BACKGROUND

• Sultana, A., Salim, A., Hanif, M., Nazir, M., Parvin, R., Sadia, N., & Nahid, K. L. (2016). Frequency, Clinical Presentation and Immediate Outcome of Hypernatraemic Dehydration in Children with Acute Diarrhoea. Bangladesh Journal of Child Health, 39(1), 18-23. https://doi.org/10.3329/bjch.v39i1.28354

  BACKGROUND

• Chisti MJ, Ahmed T, Ahmed AM, Sarker SA, Faruque AS, Islam MM, Huq S, Shahrin L, Bardhan PK, Salam MA. Hypernatremia in Children With Diarrhea: Presenting Features, Management, Outcome, and Risk Factors for Death. Clin Pediatr (Phila). 2016 Jun;55(7):654-63. doi: 10.1177/0009922815627346. Epub 2016 Jan 24.

  PMID: 26810623 BACKGROUND

Related Links

• WHO. Diarrhoeal Disease 2024
• III JLL. Hypernatremia MSD Manual Professional Edition: MSD Manual; 2025 \[updated 2025/06.
• Related Info

MeSH Terms

Conditions

Hypernatremia

Interventions

World Health Organization oral rehydration solution

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Haimanti Saha

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: October 21, 2026
• Study Start: January 13, 2026
• Primary Completion (Estimated): December 12, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)