Comparison of targeted treatment based on measuring oxygenation by central venous access versus usual care in children with septic shock

Phase 4

Completed

• Conditions: Health Condition 1: R652- Severe sepsis

• Registration Number: CTRI/2018/10/016169
• Lead Sponsor: PGIMER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-11-30
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 92

Inclusion Criteria

i. All children >= 6 month to <12 years

AND

ii. Presenting to Pediatric ER with clinical septic shock

OR

iii. Developing it within 24 hours of admission to Pediatric ER

Septic shock will be defined by presence of clinically suspected sepsis with cardiovascular organ dysfunction i.e., children with persistent hypotension (MAP <5th centile for age and gender) despite 40 ml/kg of resuscitation fluid and requiring vasoactive drug infusion during first 1 hour.

Exclusion Criteria

i. Contraindications for central neck venous line insertion (IJV or Subclavian vein) like bleeding tendencies, or not accessible for line insertion due to short neck or local disease.

ii. Children already on inotrope with inotrope score of >10 at arrival to our hospital.

iii. Children with known or suspected congenital heart disease

iv. Immunocompromised patients, e.g., primary immunodeficiency disorders, HIV (exposed or positive), patients with malignancies or other diseases on immunosuppressive medications including steroids.

v. Children with chronic illness like tuberculosis, chronic liver disease, chronic kidney disease, chronic respiratory disease etc.

vi. Known Inborn errors of metabolism

vii. Children with shock primarily due to diarrhea and severe dehydration.

viii.Children with suspected healthcare associated infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified