Sepsis-induced myocardial dysfunction
Conditions
Interventions
Group I (Experimental): GHRP-6, 10.0 mg every 12 hours, administered as a slow intravenous bolus over 3 minutes (±20 seconds) for 7 to 10 days (maximum 20 doses), at the physician's discretion and acc
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB)
Eligibility
Sex/Gender
All
Age
19 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Fulfillment of the diagnostic confirmation criteria (previously described). 2. Age between 19 and 75 years, inclusive. 3. Patient voluntariness through the granting of informed consent (oral).
Exclusion criteria
Exclusion criteria: 1. History of heart disease causing systolic and/or diastolic dysfunction (e.g., dilated cardiomyopathy, ischemic heart disease), either reported by the patient or detected during medical evaluation. 2. Severe valvulopathy (stenosis and/or insufficiency) of the mitral, aortic, or tricuspid valves detected during medical evaluation. 3. Moderate-to-severe pulmonary hypertension detected during medical evaluation. 4. Ventricular rate >130/min confirmed by ECG at the time of inclusion. 5. High probability of death within the next 48 hours (APACHE II = 20). 6. Onset of DMIS after day 7 in septic shock. 7. Patients diagnosed with malignant neoplasms with a history of anthracycline treatment, who are receiving biological therapy at the time of the study, or with functional status measured by the ECOG (Eastern Cooperative Oncology Group) scale = 3. 8. Patients with stroke and NIHSS (National Institutes of Health Stroke Scale) score = 21 points. 9. Pregnancy or breastfeeding at the time of inclusion (reported by the patient or family member). 10. Patient with known mental incapacity at the time of inclusion and absence of a legal guardian to provide informed consent. 11. Patient receiving any other biological product, including participation in another clinical trial. 12. Known hypersensitivity to any of the components of the investigational formulation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ICU discharge mortality This will be assessed based on the patient’s vital status at the time of leaving the unit. The clinical outcome will be recorded, classifying the patient as alive or deceased at ICU discharge, regardless of the length of stay. | — |
Secondary
| Measure | Time frame |
|---|---|
| "Improvement and/or recovery of biventricular systolic-diastolic function. Ventricular function will be assessed through echocardiographic tests. Measurement times will be: at inclusion, daily during the first 72 hours, on treatment days 5, 7, and 10, at ICU discharge (when individualized response for each function is evaluated), and finally at hospital discharge. The parameters to be measured are: • Left ventricular systolic function: o LVEF (Simpson) o Ao VTI o Lateral MAPSE o S' • Left ventricular diastolic function: o e' o E/e' o E/A • Right ventricular systolic function: o TAPSE o S'" • Improvement of organ function. This will be determined by the delta SOFA 2, defined as the difference between the maximum score recorded during the first 72 hours of treatment and the score obtained at the end of treatment. Evaluation will be performed daily during the first 72 hours, then on days 5, 7, and 10, as well as at ICU discharge and at hospital discharge. The systems to be evaluated will be: o Respiratory: Partial pressure of oxygen / fraction of inspired oxygen (PO2/FiO2) and oxygen saturation / fraction of inspired oxygen (SpO2/FiO2). o Renal: Creatinine / Diuresis o Hepatic: Total bilirubin o Cardiovascular: Mean arterial pressure (MAP) or drugs o Hematologic: Platelet count oNeurologic: Glasgow Coma Scale • Hospital discharge mortality. This will be assessed based on the patient’s vital status at the time of leaving the hospital, classifying the patient as alive or deceased at hospital discharge, regardless of the length of stay in the healthcare facility. • Safety: The presence of adverse events will be evaluated through physical examination and laboratory tests: o Clinical adverse events: The type, duration, intensity, causal relationship, management, and outcome will be described. For this purpose, the patient will be evaluated through interview, physical examination, and monitoring of organ functions, at least daily during hospitalization, but also at any other | — |
Countries
Cuba
Contacts
Public ContactOlga Eliseo Gregorio
Center for Genetic Engineering and Biotechnology (CIGB)
Outcome results
None listed