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Is fluid bolus required in the resuscitation of severe sepsis and septic shock in children?

Initial Fluid Bolus Versus No Bolus in the resuscitation of septic shock in children. A randomised control trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/033112
Enrollment
40
Registered
2021-04-26
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: R652- Severe sepsis

Interventions

Intervention1: Intervention: Patients (1 month to 14 years old) presenting to the paediatric emergency with criteria fulfilling for septic shock will undergo a bedside ultrasonography to look for IVC

Sponsors

Dr Swasti Keshri
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: fulfilling the case definition of septic shock defined by survival sepsis guideline [definition of SIRS, sepsis, septic shock taken from International Paediatric Sepsis Conference, 2005.

Exclusion criteria

Exclusion criteria: 1)Hypovolemic shock â?? haemorrhagic shock, gastroenteritis, burns, trauma, diabetic ketoacidosis 2)Conditions in which volume expansion is guarded- severe anaemia eg due to sickle cell anaemia, malaria, cardiogenic shock with congestive heart failure, acute kidney injury, dengue shock 3)Severe acute malnutrition (SAM) 4)Patients who have already received some form of treatment in the form of fluid boluses or inotropes from other hospital 5)Patients who are terminally ill and will require cardiopulmonary resuscitation at presentation to Pediatric Emergency.

Design outcomes

Primary

MeasureTime frame
To compare the two groups in terms of reversal of shock in children (Group A â?? without intravenous fluid bolus and early initiation of inotropes, Group B â?? managing the shock as per survival sepsis guidelines)Timepoint: 1 hour, 6 hours, 48 hours, reversal of shock, death/discharge

Secondary

MeasureTime frame
1)To compare mortality of the two groups at 48 hours and overall outcome 2)To assess for end point i.e., mean time of resolution of shock in the two groups 3)To compare volume status (preload) in the two groups- by clinical examination and by measuring IVC collapsibility by bedside ultrasound Timepoint: 1 hour, 6 hours, 48 hours, resolution of shock, length of hospital stay, final outcome(death/discharge)

Countries

India

Contacts

Public ContactSwasti Keshri

AIIMS Raipur

akgoel@aiimsraipur.edu.in9810144784

Outcome results

None listed

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