RPCEC00000426
Not yet recruiting
Phase 2
Exploratory study to evaluate the effect and safety of the administration of growth hormone-releasing peptide (CIGB-500) compared with placebo in seriously ill patients with shock - ShockExplorer-500
Center for Genetic Engineering and Biotechnology (CIGB)0 sites234 target enrollmentJuly 6, 2023
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Cardiogenic and septic shock up to level C
- Sponsor
- Center for Genetic Engineering and Biotechnology (CIGB)
- Enrollment
- 234
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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