Fluid bolus administration over 15-20 minutes versus 5-10 minutes each in children with septic shock

Administration of fluid bolus over 15-20 minutes versus 5-10 minutes in children with septic shock in the â??first hourâ?? of resuscitationâ?? A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/09/005050

Enrollment

220

Registered

2014-09-24

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: null- Children 17 years of age with septic shock Health Condition 2: A419- Sepsis, unspecified organism

Interventions

Intervention1: Fluid bolus over 15-20 minutes: Fluid bolus of 20 ml/kg would be administered over 15-20 minutes Control Intervention1: Fluid bolus over 5-10 minutes: Fluid bolus of 20 ml/kg would be a

Eligibility

Inclusion criteria

Inclusion criteria: Children < 18 years of age with features of septic shock with or without hypotension would be included

Exclusion criteria

Exclusion criteria: 1. Moderate to severely malnourished children (Indian Academy of Pediatrics classification for malnutrition grades 3 and 4) 2. Primary cardiac illness 3. Contraindication to central venous catheter insertion 4. Children with features of fluid overload at presentation 5. Children whose parents refuse to give an informed consent

Design outcomes

Primary

Measure	Time frame
The proportion of children requiring mechanical ventilation and/or impaired oxygenation (Oxygenation Index) in those already on ventilator Timepoint: At 6 and 24 hours of admission	—

Secondary

Measure	Time frame
To assess the effect of intervention on 1.The amount of fluid required (in ml/kg) 2. Inotropic score 3.Proportion of children attaining therapeutic end points 4.Duration of ventilation (in hours) 5.Duration of inotropic support (in hours) 6.Time to achieving therapeutic end points 7.Duration of intensive care unit (ICU) stay 8.Mortality and 9. Serum pro-BNP levels Timepoint: 1. Amount of fluid required in first 6 and 24 hours. 2. Inotropic score at 6 and 24 hours. 3. Attaining therapeutic end points at 6 hours. 4. Total duration of ventilation. 5. Total time period to achieving therapeutic end points. 6. Total duration of ICU stay 7. Serum pro BNP levels at 1 and 6 hrs post initial fluid boluses	—

Measure

Time frame

To assess the effect of intervention on 1.The amount of fluid required (in ml/kg) 2. Inotropic score 3.Proportion of children attaining therapeutic end points 4.Duration of ventilation (in hours) 5.Duration of inotropic support (in hours) 6.Time to achieving therapeutic end points 7.Duration of intensive care unit (ICU) stay 8.Mortality and 9. Serum pro-BNP levels Timepoint: 1. Amount of fluid required in first 6 and 24 hours. 2. Inotropic score at 6 and 24 hours. 3. Attaining therapeutic end points at 6 hours. 4. Total duration of ventilation. 5. Total time period to achieving therapeutic end points. 6. Total duration of ICU stay 7. Serum pro BNP levels at 1 and 6 hrs post initial fluid boluses

—

Countries

India

Contacts

Public ContactJhuma Sankar

PGIMER, Dr RML Hospital

jhumaji@gmail.com

Outcome results

None listed

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