Skip to content

Comparative study on the outcome of early goal directed therapy and standard care in children with septic shock.

Comparative study on the outcome of early goal directed therapy (EGDT) versus standard care in pediatric septic shock patients: A prospective open labeled randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/09/006169
Enrollment
220
Registered
2015-09-08
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 aged 1 month to 12-years with Suspected or confirmed sepsis AND evidence of systemic inflammatory response syndrome (SIRS)AND Evidence of either refractory hypotension OR hypoperfusion.

Interventions

Intervention1: Early Goal Directed Therapy: The EGDT protocol adapted from Rivers et al, will be commenced by the study team within 1 hour of enrolment. Control Intervention1: standard care: The stand

Sponsors

JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Suspected or confirmed sepsis AND presence of the evidence of systemic inflammatory response syndrome (SIRS) criteria AND Evidence of either refractory hypotension OR hypoperfusion.

Exclusion criteria

Exclusion criteria: 1. Contraindication to central venous catheter (CVC) insertion like active clinical bleeding and local site infections etc. 2. Primary cardiac illness. 3. Severe malnutrition. 4. Patient referred to JIPMER with in-situ internal/subclavian central line/resuscitated or stay more than 6 hours for septic shock management.

Design outcomes

Primary

MeasureTime frame
all-cause mortality in children with septic shock.Timepoint: all-cause mortality in children with septic shock at 28 days

Secondary

MeasureTime frame
To compare the length of PICU and hospital stayTimepoint: at 28 days;To compare the number of new organ dysfunctions at 24 hours and during PICU stay (SOFA, PeLOD Score).Timepoint: at 24 hours and PICU stay;To compare the proportion of patients achieved predetermined therapeutic endpoint and time taken to achieve predetermined therapeutic endpoints at 6 hours and during PICU stay.Timepoint: at 6 hours and PICU stay.;To compare the use and duration of organ support (Mechanical ventilation, vasoactive support and renal replacement therapy).Timepoint: PICU stay

Countries

India

Contacts

Public ContactDr Ramesh Kumar R

JIPMER

krramesh_iway@yahoo.co.in7373739142

Outcome results

None listed

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