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Clinical study on glucocorticoid therapy for septic shock in children

A prospective, multicenter, randomized, placebo-controlled clinical study to evaluate the efficacy and safety of glucocorticoids in septic shock in children

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035902
Enrollment
Unknown
Registered
2020-08-19
Start date
2020-12-01
Completion date
Unknown
Last updated
2021-01-18

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

Conditions

Septic shock

Interventions

Methylhexanone (medium dose group):Methylhexanone 5mg/kg.d, was divided into two static points for 3-5 days in total
methylprednisolone(low dose group):Methylprednisolone 2mg/kg.d was divided into two static points for 3-5 days in total
Placebo group:Glucose

Sponsors

Shengjing Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. Aged 29 days -18 years; 2. Meet the diagnostic criteria for septic shock: 2005 International Diagnostic Standard for children with septic shock; 3. Patients with PICU hospitalization time less than 48 hours; 4. Patients diagnosed with septic shock within 24 hours.

Exclusion criteria

Exclusion criteria: 1. Patients with known or suspected diseases of hypothalamus, pituitary gland and adrenal gland; 2. Patients with or suspected genetic metabolic diseases, leukemia, tumor, epilepsy, and immunodeficiency; 3. Patients with acute or chronic diseases who are being treated with hormone; 4. Clinicians may use glucocorticoids to treat the indications other than septic shock; 5. Patients with short-term operation less than 72 hours, or with high risk factors of bleeding, or may have surgery in the next 24 hours; 6. Patients with gastrointestinal bleeding in the past 6 weeks; 7. Highly suspected shock patients caused by other causes (such as cardiogenic and hypovolemia); 8. The researchers considered that the patients were not suitable for the study (those with poor compliance, extremely critical illness, unable to complete the trial, and expected to withdraw); 9. Patients with vasoactive drugs for non shock reasons; 10. Patients with etomidate (inhibition of adrenocortical function); 11. Amphotericin B was used to treat patients with fungal infection (which may aggravate the induced hypokalemia) 12. Participated in other clinical trials in the past month

Design outcomes

Primary

MeasureTime frame
all-cause mortality;

Secondary

MeasureTime frame
all-cause mortality;Shock recovery time;Days alive and out of the PICU;Days alive and out of the hospital;CRRT-free days to day 28;Ventilator-free days to day 28;Vasopressor-free days to day 28;Organ-failure-free days to day 28;

Countries

China

Contacts

Public ContactLiu Chunfeng

Shengjing Hospital of China Medical University

zhliu258@hotmail.com+86 18940251826

Outcome results

None listed

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