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Clinical Efficacy and Safety of Hemoperfusion in Pediatric Septic Shock: A RCT multicenter trial (CESHePS trial)

Clinical Efficacy and Safety of Hemoperfusion in Pediatric Septic Shock: A RCT multicenter trial (CESHePS trial)

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240903007
Enrollment
60
Registered
2024-09-03
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Pediatric septic shock Pediatric septic shock hemoperfusion hemodynamic morbidity

Interventions

An HA330 disposable hemoperfusion cartridge (HA330/HA60, Jafron, Zhuhai City, China) will be used with a continuous renal replacement therapy (CRRT) machine (Aquarius or Primaflex, or any other CRRT m
Experimental Device,No Intervention Other
Hemoperfusion with protocol,Control, with standard sepsis care

Sponsors

Jafron Biomedical Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Weeks to 18 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of septic shock within 24 hours with the following criterias: Confirmed diagnosis of septic shock according to established criteria (e.g., Pediatric Sepsis Definition Task Force, International Pediatric Sepsis Consensus Conference, Goldstein et al 2005) Age range: Clearly define the age range of eligible participants (e.g., Infants age from 1 month to adolescents (18 years) admitted to PICU 2. Severity: Define specific severity criteria based on validated scoring systems like PRISM III, PELOD-2, or SOFA score to ensure enrollment of critically ill patients with a high risk of mortality.

Exclusion criteria

Exclusion criteria: 1 Underlying chronic conditions ( for example cardiac or renal failure, severe liver disease) 2 Known severe bleeding diathesis or active bleeding (platelet count less than 25,000 /mm3) 3 Previous exposure to hemoperfusion within previous 1 week 4 Known allergies to components of the hemoperfusion system 5 Severe multiple organ failure 6 Multiple congenital anomaly or end of life care

Design outcomes

Primary

MeasureTime frame
clinical efficacy PICU duration vasopressor used, shock resolution,safety PICU admission bleeding at vital organs

Secondary

MeasureTime frame
survival PICU duration survival rate compare to control

Countries

Thailand

Contacts

Public ContactRujipat Samransamruajkit

408-237709-5

rujipatrs@gmail.com0818633296

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026