Severe extensive burns (2nd and 3rd degree total burn area >= 20 %) burn, heart rate, ivabradine
Conditions
Interventions
In patients with extensive burns with a total burn area >= 20 % and a heart rate > 75 beats/min, ivabradine should be started at a dose of 2.5 mg twice daily by mouth (or tube) in the morning and even
ivabradine
Sponsors
INOUE YOSHIAKI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all the following criteria will be considered 1) Burn patients aged 18 years and older with at least 20% of total burn area(2nd and 3rd degree), (regardless of gender) 2) Patients who are able to administer the drug orally or by gavage 3) Patients with a sustained resting (sedated)heart rate of 75 beats/minute or greater, and whose physician has determined that ivabradine can be administered. 4) Sinus rhythm 5) Patients with no history of cardiac disease 6) Patients who have been fully informed of the study and who have given written consent of their own free will or that of a surrogate, based on a thorough understanding of the study.
Exclusion criteria
Exclusion criteria: Patients who violate any of the following will not be included in this study 1) Patients with a history of hypersensitivity to ivabradine 2) Patients on Clozapine 3) Persistent circulatory failure unresponsive to supplemental fluids or standard vasoactive agents 4) Patients with severe hypotension (systolic pressure less than 90 mmHg or diastolic pressure less than 50 mmHg despite infusion load and standard vasoactive drugs) 5) Patients with severe hepatic impairment (Child-Pugh C) 6) Patients with right heart failure due to pulmonary hypertension 7) Patients receiving ritonavir-containing products, josamycin, itraconazole, clarithromycin, cobicistat-containing products, voriconazole, encitrelvir fumarate, verapamil, diltiazem 8) Women who are pregnant or may become pregnant 9) Lactating women 10) Other patients deemed inappropriate as subjects by the principal investigator (or subinvestigator)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of hypotension (systolic pressure less than 90 mmHg or diastolic pressure less than 50 mmHg) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adrenaline, insulin, ketone bodies (acetoacetate, beta hydroxybutyrate as markers of metabolism, O2 and CO2 in exhaled air, blood glucose, free fatty acids, lactic acid, lipid metabolic indices (TG, CHO, LDL, VLDL, HDL) Frequency of bradycardia (50 beats/minute) Evaluation of liver, renal, and cardiac function Incidence rate of hypotensive shock Presence or absence of arrhythmias such as atrioventricular block, atrial fibrillation, QT prolongation, etc. Light sensitivity, foggy vision, or no light sensitivity Intravenous fluid requirements and contents during ICU/HCU admission, urine volume, weight change, change in serum albumin level, albumin dosage, length of stay in ICU/HCU and length of hospital stay. Amount of calories consumed by indirect calorimetry Compare the above items with patients with BI of 20 or more treated at this hospital during the past 5 years. Biomarkers (TNF-alpha, ANP, BNP, IL-6, IL-8, IL-10, TGF-beta) Burn site healing, presence of wound infection, presence of surgical procedures, pain assessment | — |
Contacts
Public ContactKEISYUN BOKU
University of Tsukuba Hospital
Outcome results
None listed