Organ Protective Effect of Cetirizine In Patients With Severe Burns

Burns Clinical Trial

Official title:

Organ Protective Effect of Histamine H1 Receptor Antagonist In Patients With Severe Burns: A Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06126991
• Other study ID #: RuijinH_20230318
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 23, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Ruijin Hospital
• Contact: Yan Liu
• Phone: 021-64370045
• Email: rjliuyan[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 90 Years

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

Related Conditions & MeSH terms

• Burns

Intervention

Drug:
• Cetirizine
Oral administration of cetirizine at 10mg once daily will be used.
• 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.

Locations

Country	Name	City	State
China	Department of Burn, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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 — View 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. — View Citation

Outcome

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