This prospective clinical trial aims to investigate the organ protective effects of cetirizine in patients with severe burns.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
32
Oral administration of cetirizine at 10mg once daily will be used.
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.
Department of Burn, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGAPACHE 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.
Time frame: Day 7
Urinary Output
Observation of 24-hour urinary output (ml) 7 days after admission.
Time frame: Day 7
Blood L-lactate
Observation of Blood L-lactate level 7 days after admission.
Time frame: Day 7
Base Excess (BE)
Observation of base excess in blood 7 days after admission.
Time frame: Day 7
Oxygen Saturation
Observation of oxygen saturation in blood 7 days after admission.
Time frame: Day 7
Stroke Volume Variation
Observation of stroke volume variation (SVV) in PICCO or Uscom 7 days after admission.
Time frame: Day 7
Global End-Diastolic Volume
Observation of global end-diastolic volume (GEDV) in PICCO or Uscom 7 days after admission.
Time frame: Day 7
Central Venous Pressure
Observation of central venous pressure (CVP) in PICCO or Uscom 7 days after admission.
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Time frame: Day 7
Stroke Volume
Observation of stroke volume 7 days after admission.
Time frame: Day 7
Cardiac Function Index
Observation of Cardiac Function Index (CFI) 7 days after admission.
Time frame: Day 7
Pulmonary interstitial edema
Observation of extravascular lung water index (ELWI) or chest x-ray 7 days after admission.
Time frame: 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.
Time frame: Day 7
Body Temperature
Observation of body temperature 7 days after admission.
Time frame: Day 7
Heart Rate
Observation of heart rate 7 days after admission.
Time frame: Day 7
Respiratory Rate
Observation of respiratory rate 7 days after admission.
Time frame: Day 7
Leukocyte Count
Observation of leukocyte count in blood 7 days after admission.
Time frame: Day 7
Blood CRP
Observation of blood CRP (C-reactive protein) 7 days after admission.
Time frame: Day 7
Blood Calcitoninogen
Observation of blood calcitoninogen 7 days after admission.
Time frame: Day 7
Mechanical Ventilation Duration
Observation of mechanical ventilation duration during 28 days after admission.
Time frame: Day 28
Mortality
Observation of mortality during 28 days after admission.
Time frame: Day 28
Sepsis Rate
Observation of sepsis rate during 28 days after admission.
Time frame: Day 28