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 个研究点目标入组 234 人开始时间: 2023年7月6日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment

•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.

•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.

发起方

Center for Genetic Engineering and Biotechnology (CIGB)