Organ Protective Effect of Cetirizine In Patients With Severe Burns

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-23

Study Completion Date

2025-12-31

Brief Summary

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

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Detailed Description

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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

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Burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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The Modified Sedation and Analgesia Regimen Group

midazolam, fentanyl, cetirizine

Group Type EXPERIMENTAL

Cetirizine

Intervention Type DRUG

Oral administration of cetirizine at 10mg once daily will be used.

Midazolam and Fentanyl

Intervention Type DRUG

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.

The Sedation and Analgesia Regimen Group

midazolam, fentanyl

Group Type ACTIVE_COMPARATOR

Midazolam and Fentanyl

Intervention Type DRUG

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.

Interventions

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Cetirizine

Oral administration of cetirizine at 10mg once daily will be used.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No