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Microcirculation in septic shock in children

Assessing the microcirculation and its response to different fluid volumes in children with septic shock- A randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/045059
Enrollment
150
Registered
2022-08-30
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Health Condition 1: I998- Other disorder of circulatory system

Interventions

Intervention1: 5 mL/kg: Administration of the first fluid bolus will be at a volume of 5 mL/kg per bolus over 5-10 minutes in hypotensive shock and over 20-30 minutes in compensated shock will be give

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All children 2 months to less than 17 years of age admitted to the emergency/ICU with a diagnosis of septic shock will be eligible for inclusion. At least 3 of the following criteria should be present of which criteria no.1 is essential criteria – 1) capillary refill time 2 seconds or less than 1 second, 2) cold extremities 3) feeble or bounding peripheral pulses 4) hypotension (systolic BP less than 5th centile as per PALS guidelines) and 5) history of decreased urine output

Exclusion criteria

Exclusion criteria: 1.Children who received boluses before enrolment 2. Children with chronic kidney disease / fulminant myocarditis / dengue shock syndrome / 3. Children with severe anemia (Hb 4. Post-arrest shock and cardiac dysfunction 5. Moribund patients with anticipated survival of

Design outcomes

Primary

MeasureTime frame
1. Change in mottling score before and after 15 minutes of the bolus and reassessed at 1 hour and 6 hours of fluid resuscitation. 2. Change in surface temperature gradient between centre to periphery before and after 15 minutes of the bolus and reassessed at 1 hour and 6 hours of fluid resuscitation. 3. Change in biomarkers of endothelial dysfunction will be assessed at baseline, after 1 hour of the first bolus and at 6 hours and 24 hours of fluid resuscitation.Timepoint: At baseline and after 15 minutes of the first bolus, at 1 hour and 6 hours of enrolment

Secondary

MeasureTime frame
The agreement between the macrocirculation and the microcirculationTimepoint: Will be assessed after 15 minutes of the first fluid bolus and repeated at 1 hour and 6 hours of resuscitation.

Countries

India

Contacts

Public ContactJhuma sankar

AIIMS

jhumaji@gmail.com9818399864

Outcome results

None listed

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