Cardiogenic and septic shock up to level C
Conditions
Interventions
CIGB-500 Group (Experimental): 10 mg of the product will be received every 12 hours for 7-10 days (until completing a maximum of 20 administrations of the product), always in an intravenous bolus of 3
Peptides
Administration, Intravenous
Placebos
CIGB-500
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Fulfillment of diagnostic criteria. 2. Patients of either sex, aged 18 years or older. 3. Willingness of the patient or legal representative to grant written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Patients with hypovolemic shock 2. Patients who at the time of admission to the intensive care unit are in multiple organ dysfunction. Multiple Organ Dysfunction (MOD) will be considered as: Acute, progressive, sequential or simultaneous and potentially reversible impairment of functions in various interdependent organ systems (2 or more previously healthy organs and systems far from the site of the condition of origin). Alterations in homeostasis are impossible to reverse without therapy. It usually begins with pulmonary failure, being followed by dysfunction of the CNS, liver, intestine, kidneys, and other organs that are not necessarily involved in the primary disease, nor do they appear in a predetermined order. Synonyms: Multiple Organ Failure (MOF). 3. Pregnancy or lactation at the time of inclusion in the study (referred). 4. Obvious mental incapacity to issue consent and act accordingly with the study (not related to the state of shock). 5. Patients with known hypersensitivity to any component of the formulation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Shock reversal (Yes, No, based on Echocardiogram results and physical examination). Measurement time: At baseline, Day 3, 5 and 7, and at the end of the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Decrease in volume loading needs in the decompensated phase (Yes, No). Measurement time: At baseline, Day 3, 5 and 7, and at the end of the treatment. 2. Decreased incidence of liver damage (Yes, No, based on the results of the liver profile). Measurement time: At baseline, and at the end of the treatment. 3.Decreased bleeding. (Yes, No based on the results of the coagulogram). Measurement time: At baseline, and at the end of the treatment. 4. Decreased need to use vasoactive drugs (Yes, No). Measurement time: At baseline, Day 3, 5 and 7, and at the end of the treatment 5. Presence of tissue hypoperfusion (Yes, No based on the systolic blood pressure (SBP) figures, the presence of multifocal atrial tachycardia (MAT) and lactate figures). Measurement time: At baseline,Day 3, 5 and 7, and at the end of the treatment 6. Presence of acute respiratory failure (Yes, No based on blood gases). Measurement time: At baseline, Day 3, 5 and 7, and at the end of the treatment 7. 28-day mortality (Patient status as Alive, Deceased). Measurement time: 28 days 8.Evaluation of cardiac damage in patients in cardiogenic shock (Yes, No, based on the values ??of the damage-marking enzymes CK-MB and Troponin T). Measurement time: At the beginning, and at the end of the treatment 9. Adverse events-AE (Occurrence of any AE (Yes, No), AE description (AE name), AE duration (difference in AE start and end date), AE intensity (1. Mild, 2 Moderate, 3. Severe), severity of the AE (1.Not Serious/Not Serious, 2.Causes death, 3.Threats to life, 4.Requires/prolongs hospitalization, 5.Produces significant or persistent disability/invalidity, 6.Produce congenital anomaly or birth defect.), attitude regarding study treatment (1.No change, 2.Dose modification, 3.Temporary interruption, 4.Definite interruption), AE result (1.Recovered, 2.Persists, 3.Recovered with sequelae, 4.Death due to AE, 5.Unknown), causal relationship (1.Very Likely/Sure, 2.Likely, 3.Possible, 4.Unlikely, 5.Not related, 6.Not ev | — |
Countries
Cuba
Contacts
Public ContactIvis Mendoza Hernandez
National Coordinating Clinical Trials Center (CENCEC)
Outcome results
None listed