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Organ Protective Effect of Cetirizine In Patients With Severe Burns

Organ Protective Effect of Cetirizine In Patients With Severe Burns

Recruiting
12-90 years
All
Phase 1/2

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Overview

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

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.

Eligibility

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

Study details
    Burns

NCT06126991

Ruijin Hospital

14 February 2024

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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