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Use of hetastarch for maintaining fluid balance in children with severe dengue

Pilot study to assess feasibility of using Hetastarch for fluid resuscitation in children with severe dengue: A phase II Observational Trial - HetaD

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/10/046626
Enrollment
50
Registered
2022-10-19
Start date
Unknown
Completion date
Unknown
Last updated
2022-11-21

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]

Interventions

Intervention1: NIL: NIL

Sponsors

Apollo Childrens Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants whose parent(s)/guardian(s) is/are willing and able to give informed consent for participation in the study. 2. Children who are still in shock despite the initial 20ml/kg resuscitation fluid in the initial 6 hours of shock. The resuscitation fluid must be a crystalloid

Exclusion criteria

Exclusion criteria: 1. Patients has evidence of Significant bleeding or drop in HCT requiring transfusion 2. Patients who have already received any colloid prior to enrolment 3. Admission in recovery phase of dengue 4. Patients with chronic renal failure or pre-existing liver failure or pre-existing thrombocytopenia or coagulation disorder (such as ITP or haemophilia). 5. Requirement of CRRT or plasma exchange for indications other than acute kidney injury such as liver failure. 6. Parent(s)/guardian(s) are not willing for enrolment

Design outcomes

Primary

MeasureTime frame
To assess the safety of synthetic colloid with respect to renal function and coagulation function in paediatric dengue shock syndrome.Timepoint: Day-0; Within 2 hours of initiating the synthetic colloid or albumin Day-1 After 24 hours Day-5 or discharge (whichever is earlier) Day 28 of starting the colloid

Secondary

MeasureTime frame
1. To assess the efficacy of synthetic colloid with respect to the need for â??rescue colloidâ?? and â??fluid-overloadâ?? in pediatric dengue shock syndrome 2. To assess the effect of synthetic colloid with respect to survival in paediatric dengue shock syndrome Timepoint: 1. Within the initial 12 hours of admission to the ICU or high-dependency unit. 2. Day 28 survival

Countries

India

Contacts

Public ContactDr Suchitra Ranjit

Apollo Childrens Hospital

drsuchitra_r@apollohospitals.com9840024456

Outcome results

None listed

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