Exploratory study to evaluate the effect and safety of CIGB 500 in seriously ill patients with shock

Phase 2

• Conditions: Cardiogenic and septic shock up to level C; Inflammation; Systemic Inflammatory Response Syndrome; Sepsis; Shock, Septic; Cardiovascular Diseases; Vascular Diseases; Heart Diseases; Shock, Cardiogenic; Myocardial Infarction

• Registration Number: RPCEC00000426
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-06
• Last Update Posted: 19 August 2024
• Study Completion: 2024-11-20
• Results First Posted: 2024-12-28

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 234

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.