NCT06126991

Organ Protective Effect of Cetirizine In Patients With Severe Burns

Organ Protective Effect of Histamine H1 Receptor Antagonist In Patients With Severe Burns: A Clinical Study

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 12 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This prospective clinical trial aims to investigate the organ protective effects of cetirizine in patients with severe burns.

Detailed description

This is a prospective, randomized, single-blind, parallel-controlled clinical trial. The global objective is to compare the organ protective effects of the sedation and analgesia regimen (midazolam, fentanyl) with the modified sedation and analgesia regimen (midazolam, fentanyl, cetirizine) in patients with severe burns (≥30% TBSA). Participants will receive the intervention from admission to 72 hours post-burn. Researchers will take the APACHE II scores on days 7 after admission as the main outcomes. Researchers will also take other supplementary examination results into account, including liver enzyme, myocardial enzyme, renal function, haemodynamic index, coagulation function, and pulmonary interstitial edema.

Conditions

• Burns

Interventions

Type	Name	Description
DRUG	Cetirizine	Oral administration of cetirizine at 10mg once daily will be used.
DRUG	Midazolam and Fentanyl	Midazolam 50mg + fentanyl 300ug micro pump push will be used with a starting dose of 5ml/hour, adjusted according to the patient's level of sedation. The patient's RASS score will be maintained between -1-0 and the drug will be suspended with a blood pressure below 90/60mmHg.

Timeline

• Start date: 2024-01-23
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2023-11-13
• Last updated: 2024-02-01

Locations

1 site across 1 country: China