Cetirizine's effects on organ protection in severe burn patients
Organ Protective Effect of Histamine H1 Receptor Antagonist In Patients With Severe Burns: A Clinical Study
This study is testing if adding cetirizine to the usual pain relief for patients with severe burns can help protect their organs and improve their recovery.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 12 Years to 90 Years |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06126991 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the organ protective effects of cetirizine in patients with severe burns covering more than 30% of their total body surface area. It is a prospective, randomized, single-blind, parallel-controlled trial comparing a standard sedation and analgesia regimen with a modified regimen that includes cetirizine. Participants will receive treatment from the time of admission until 72 hours post-burn, with outcomes assessed using APACHE II scores and various organ function tests. The study aims to determine if cetirizine can improve organ function in this vulnerable patient population.
Who should consider this trial
Good fit: Ideal candidates are patients with severe burns (≥30% TBSA) who are admitted within the first day after their injury.
Not a fit: Patients with severe compound injuries, mental illness, or significant pre-existing health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved organ protection and outcomes for patients suffering from severe burns.
How similar studies have performed: While the specific use of cetirizine in this context may be novel, similar studies exploring organ protection in burn patients have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed and dated informed consent form * Commitment to comply with the procedures and cooperation during the course * TBSA \>30% and admitted within the first day after burns * No severe compound injuries Exclusion Criteria: * History of allergy to drugs in the trial * Postoperative complications that would interfere with the observation * Mental illness and severe heart disease, hypertension * Serious genetic diseases * Incomplete clinical information (unclear diagnosis, incomplete medical history, incomplete medication records, etc.) * Pregnancy/lactation * Malignant tumors * Organ insufficiency due to previous chronic diseases such as hypertension, diabetes mellitus or non-burning factors * Serious adverse reactions * Self-requested withdrawal
Where this trial is running
Shanghai, Shanghai
- Department of Burn, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Yan Liu — Ruijin Hospital
- Study coordinator: Yan Liu
- Email: rjliuyan@126.com
- Phone: 021-64370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.