Clinical trial NCT06126991: Organ Protective Effect of Cetirizine In Patients With Severe Burns
Official title: Organ Protective Effect of Histamine H1 Receptor Antagonist In Patients With Severe Burns: A Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Burns
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 32
Sex: ALL
Minimum age (years): 12
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: APACHE II on Day 7
timeFrame: Day 7
Secondary outcomes:
measure: Urinary Output
timeFrame: Day 7
measure: Blood L-lactate
timeFrame: Day 7
measure: Base Excess (BE)
timeFrame: Day 7
measure: Oxygen Saturation
timeFrame: Day 7
measure: Stroke Volume Variation
timeFrame: Day 7
measure: Global End-Diastolic Volume
timeFrame: Day 7
measure: Central Venous Pressure
timeFrame: Day 7
measure: Stroke Volume
timeFrame: Day 7
measure: Cardiac Function Index
timeFrame: Day 7
measure: Pulmonary interstitial edema
timeFrame: Day 7
measure: SOFA Score
timeFrame: Day 7
measure: Body Temperature
timeFrame: Day 7
measure: Heart Rate
timeFrame: Day 7
measure: Respiratory Rate
timeFrame: Day 7
measure: Leukocyte Count
timeFrame: Day 7
measure: Blood CRP
timeFrame: Day 7
measure: Blood Calcitoninogen
timeFrame: Day 7
measure: Mechanical Ventilation Duration
timeFrame: Day 28
measure: Mortality
timeFrame: Day 28
measure: Sepsis Rate
timeFrame: Day 28
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Burn, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Yan Liu
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.