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

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

Study Overview

• Status: Recruiting
• Conditions: Burns
• Intervention / Treatment: Drug: Cetirizine; Drug: Midazolam and Fentanyl

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 Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Yan Liu; Phone Number: 021-64370045; Email: rjliuyan@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Department of Burn, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
      • Contact: Yan Liu; Phone Number: 021-64370045; Email: rjliuyan@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The Modified Sedation and Analgesia Regimen Group; midazolam, fentanyl, cetirizine	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.
Active Comparator: The Sedation and Analgesia Regimen Group; midazolam, fentanyl	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
APACHE II on 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.	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary Output	Observation of 24-hour urinary output (ml) 7 days after admission.	Day 7
Blood L-lactate	Observation of Blood L-lactate level 7 days after admission.	Day 7
Base Excess (BE)	Observation of base excess in blood 7 days after admission.	Day 7
Oxygen Saturation	Observation of oxygen saturation in blood 7 days after admission.	Day 7
Stroke Volume Variation	Observation of stroke volume variation (SVV) in PICCO or Uscom 7 days after admission.	Day 7
Global End-Diastolic Volume	Observation of global end-diastolic volume (GEDV) in PICCO or Uscom 7 days after admission.	Day 7
Central Venous Pressure	Observation of central venous pressure (CVP) in PICCO or Uscom 7 days after admission.	Day 7
Stroke Volume	Observation of stroke volume 7 days after admission.	Day 7
Cardiac Function Index	Observation of Cardiac Function Index (CFI) 7 days after admission.	Day 7
Pulmonary interstitial edema	Observation of extravascular lung water index (ELWI) or chest x-ray 7 days after admission.	Day 7
SOFA Score	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.	Day 7
Body Temperature	Observation of body temperature 7 days after admission.	Day 7
Heart Rate	Observation of heart rate 7 days after admission.	Day 7
Respiratory Rate	Observation of respiratory rate 7 days after admission.	Day 7
Leukocyte Count	Observation of leukocyte count in blood 7 days after admission.	Day 7
Blood CRP	Observation of blood CRP (C-reactive protein) 7 days after admission.	Day 7
Blood Calcitoninogen	Observation of blood calcitoninogen 7 days after admission.	Day 7
Mechanical Ventilation Duration	Observation of mechanical ventilation duration during 28 days after admission.	Day 28
Mortality	Observation of mortality during 28 days after admission.	Day 28
Sepsis Rate	Observation of sepsis rate during 28 days after admission.	Day 28

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Principal Investigator: Yan Liu, Ruijin Hospital

Publications and helpful links

General Publications

• Zhang M, Yang P, Yu T, Harmsen MC, Gao M, Liu D, Shi Y, Liu Y, Zhang X. Lytic cocktail: An effective method to alleviate severe burn induced hyper-metabolism through regulating white adipose tissue browning. Heliyon. 2022 Mar 17;8(3):e09128. doi: 10.1016/j.heliyon.2022.e09128. eCollection 2022 Mar.
• Wang J, Lu C, Zhang J, Gao M, Liu D, Yang P, Yu T, Wang X, Zhang X, Liu Y. LYTIC COCKTAIL ATTENUATES CATECHOLAMINE SURGE AFTER SEVERE BURNS BY BLOCKING HISTAMINE H1 RECEPTOR/PKA/CREB/TYROSINE HYDROXYLASE SIGNALING IN CHROMAFFIN CELLS. Shock. 2022 Aug 1;58(2):158-168. doi: 10.1097/SHK.0000000000001963. Epub 2022 Jul 24.
• Wang J, Lu C, Liu X, Zhang G, Zhang J, Gao M, Liu D, Zhang X, Liu Y. Histamine H1 receptor antagonist attenuates catecholamine surge and organ injury after severe burns. Front Endocrinol (Lausanne). 2023 Feb 9;14:1068925. doi: 10.3389/fendo.2023.1068925. eCollection 2023.

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 30, 2023
• First Submitted That Met QC Criteria: November 6, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Fentanyl; Midazolam; Cetirizine
• Other Study ID Numbers: RuijinH_20230318

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No