Organ Protective Effect of Cetirizine In Patients With Severe Burns

Phase 1

Recruiting

• Conditions: Burns
• Interventions: Drug: Cetirizine; Drug: Midazolam and Fentanyl

• Registration Number: NCT06126991
• Lead Sponsor: Ruijin Hospital

Brief 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.

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-30
• Study First Submitted QC: 2023-11-06
• Study First Posted: 2023-11-13
• Study Start: 2024-01-23
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-02-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The Modified Sedation and Analgesia Regimen Group	Midazolam and Fentanyl	midazolam, fentanyl, cetirizine
The Sedation and Analgesia Regimen Group	Midazolam and Fentanyl	midazolam, fentanyl
The Modified Sedation and Analgesia Regimen Group	Cetirizine	midazolam, fentanyl, cetirizine

Primary Outcome Measures

Name	Time	Method
APACHE II on Day 7	Day 7	Observation of APACHE II scores of patients in each group 7 days after admission.; The APACHE II (Acute Physiology And Chronic Health Evaluation II) is a severity-of-disease classification system. An integer score from 0 to 71 is computed based on several measurements. Higher scores correspond to more severe disease and a higher risk of death.

Secondary Outcome Measures

Name	Time	Method
Oxygen Saturation	Day 7	Observation of oxygen saturation in blood 7 days after admission.
Urinary Output	Day 7	Observation of 24-hour urinary output (ml) 7 days after admission.
Blood L-lactate	Day 7	Observation of Blood L-lactate level 7 days after admission.
Base Excess (BE)	Day 7	Observation of base excess in blood 7 days after admission.
Stroke Volume Variation	Day 7	Observation of stroke volume variation (SVV) in PICCO or Uscom 7 days after admission.
Global End-Diastolic Volume	Day 7	Observation of global end-diastolic volume (GEDV) in PICCO or Uscom 7 days after admission.
Central Venous Pressure	Day 7	Observation of central venous pressure (CVP) in PICCO or Uscom 7 days after admission.
Stroke Volume	Day 7	Observation of stroke volume 7 days after admission.
Cardiac Function Index	Day 7	Observation of Cardiac Function Index (CFI) 7 days after admission.
Pulmonary interstitial edema	Day 7	Observation of extravascular lung water index (ELWI) or chest x-ray 7 days after admission.
SOFA Score	Day 7	Observation of SOFA score 7 days after admission.; The SOFA score (Sequential Organ Failure Assessment Score) is a scoring system associated with the organ function or rate of function of patients. An integer score from 0 to 24 is computed based on 6 different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). Higher scores correspond to more severe organ function disorders or failures.
Body Temperature	Day 7	Observation of body temperature 7 days after admission.
Heart Rate	Day 7	Observation of heart rate 7 days after admission.
Respiratory Rate	Day 7	Observation of respiratory rate 7 days after admission.
Leukocyte Count	Day 7	Observation of leukocyte count in blood 7 days after admission.
Blood CRP	Day 7	Observation of blood CRP (C-reactive protein) 7 days after admission.
Blood Calcitoninogen	Day 7	Observation of blood calcitoninogen 7 days after admission.
Mechanical Ventilation Duration	Day 28	Observation of mechanical ventilation duration during 28 days after admission.
Mortality	Day 28	Observation of mortality during 28 days after admission.
Sepsis Rate	Day 28	Observation of sepsis rate during 28 days after admission.

Trial Locations

Locations (1)

Department of Burn, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China