Sepsis
Conditions
Interventions
rhBNP Group (rhBNP treatment):None
Sponsors
Guangdong Second Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1: Patients over 18 years old and under 85 years old admitted to the ICU 2: Meets the diagnostic criteria for sepsis, and according to the 2021 edition of the "Save Sepsis Campaign (SSC) Guidelines", patients with infection or suspected infection have an SOFA score increase of >= 2 points from baseline; 3: Complies with sepsis induced cardiac disorders or acute exacerbations, i.e. NYHA functional class III-IV (referring to the functional class of the New York College of Cardiology), or has at least one objective evidence of myocardial injury: 1) elevated myocardial injury markers, such as abnormal elevation of troponin I/T and BNP/NT proBNP; 2) imaging evidence: echocardiography shows a decrease in left ventricular ejection fraction (LVEF) (= 26.5 µ mol/L within 48 hours; Within 7 days, the blood creatinine level increases to more than 1.5 times the baseline; Urine output<0.5 ml · kg ?¹· h ?¹ for more than 6 hours; 5: The patient's relatives or legal guardians agree to participate in the trial and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1: When screening, it meets the diagnosis of cardiogenic shock, including but not limited to the following symptoms: 1) persistent hypotension (after treatment with vasopressors, the mean arterial pressure remains below 60mmHg); 2) Shock and tissue hypoperfusion manifestations, such as changes in consciousness, skin cyanosis, cold limbs, oliguria or anuria, etc; 2: The dosage of vasoactive drugs required is larger than 0.4ug/kg/min; 3: Researchers have determined that patients who are not suitable for the use of vasodilators, such as those with severe valve stenosis, restrictive or obstructive cardiomyopathy, restrictive pericarditis, pericardial tamponade, or other cardiac output dependent venous return, or suspected of having low filling pressure in the heart, are not suitable; 4: History of chronic renal failure in the past, and failure to maintain stable renal function through treatment; 5: Individuals who are known or suspected to be allergic to the test product or its components; 6: Any other situation that researchers believe may put patients at risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NT-proBNP; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in two-dimensional Doppler parameters of the heart before and after treatment;On the 3rd and 5th day after treatment, there were changes in inflammatory indicators compared to baseline, including high-sensitivity C-reactive protein (hs CRP), interleukin-6 (IL-6), and serum SAA;renal function, Including serum creatinine (Scr, µ mol/L), urea nitrogen (BUN), estimated glomerular filtration rate (eGFR), AKI staging based on KDIGO criteria;Changes in serum uremic toxin (UTs) concentration from baseline on the 3rd and 5th day after treatment;APACHE II;Sequential Organ Failure Assessment (SOFA);The probability of cardiovascular events occurring within 5 days of treatment and the incidence of emergency blood purification therapy in two groups of patients;Total length of ICU stay; | — |
Countries
China
Contacts
Public ContactQiujiang Liu
Guangdong Second Traditional Chinese Medicine Hospital
Outcome results
None listed