Skip to content

Comparison of the effect of Plasmalyte-A versus 0.9% normal saline as intravenous fluid therapy on serum bicarbonate levels in children with Dengue.

Plasmalyte-A versus Normal saline for fluid replacement therapy in Dengue in children: A Randomized Controlled Trial - Nil

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/066542
Enrollment
80
Registered
2024-04-30
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A90- Dengue fever [classical dengue] Health Condition 2: A91- Dengue hemorrhagic fever

Interventions

Intervention1: Plasmalyte-A: Baseline clinical data and laboratory data will be recorded. Intravenous fluid therapy will be given as per the disease classification. (1) Dengue with warning signs: P

Sponsors

JAWAHARLAL NEHRU MEDICAL COLLEGE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed cases of dengue based on clinical features and laboratory reports (including Dengue IgM,IgG and NS1 levels) requiring intravenous fluid therapy

Exclusion criteria

Exclusion criteria: (1)Comorbid conditions that may affect the outcome of the study like chronic liver disease, congenital heart disease, etc (2) Allergies to Normal saline (0.9%) or Plasmalyte-A (3)Patients with PeLOD-2 score of more than or equal to 14 (4) Refusal to participate in the study

Design outcomes

Primary

MeasureTime frame
Change in plasma bicarbonate levelTimepoint: At enrollment and after 6 hours of administration of replacement fluid

Secondary

MeasureTime frame
Duration of hospital stay and in-hospital mortalityTimepoint: till discharge or in-hospital mortality;Glasgow coma scaleTimepoint: 6 hours;Serum electrolytes (Na, K, Ca), urea, creatinine, glucose and haematocrit levelTimepoint: 0 hours and 6 hours;Total volume of fluid received, Fluid rate, urine output and proportion with fluid overloadTimepoint: 6 hours

Countries

India

Contacts

Public ContactHAZIQ AHMAD CHAND

Department of Pediatrics, Jawaharlal Nehru Medical College , AMU, Aligarh

drkafzal@hotmail.com05712721182

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026