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

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

ShockExplorer

Scientific title:

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

Acronym of Scientific Title:

ShockExplorer-500

Secondary indentifying numbers:

IG/CIGB-500EV/SCS/2301

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB), Havana, Cuba. Ministry of Public Health (MINSAP), Cuba

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Luis

Midle name:

Enrique

Last name:

Rodriguez Ordaz

Medical Specialty :

First degree specialist in Intensive care and Emergency Medicine

Affiliation:

Diez de Octubre Clinical Surgical Teaching Hospital

Postal address:

Calzada 10 de Octubre No. 130 e/. Alejandro Ramirez y Agua Dulce

City:

Havana

País:

Cuba

Zip Code:

10300

Telephone:

+53-78252291

Email address:

mayoho@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana, Salvador Allende Clinical Surgical Teaching Hospital, PhD. Jorge Jimenez Armada. Second Degree Specialist in Intensive care and Emergency Medicine

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

20/09/2023

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Cardiogenic and septic shock up to level C

Health condition(s) code:

Shock, Cardiogenic

Myocardial Infarction

Myocardial Ischemia

Heart Diseases

Vascular Diseases

Cardiovascular Diseases

Shock, Septic

Sepsis

Systemic Inflammatory Response Syndrome

Inflammation

Shock

Pathologic Processes

Intervention(s):

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 minutes (±20 seconds) duration. Placebo Group (Control): CIGB-500 placebo administered at the same dose, route of administration, frequency and duration as the experimental group

Intervention code:

Peptides

Administration, Intravenous

Placebos

Intervention keyword:

CIGB-500

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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.

Key secondary outcomes:

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 evaluable/Not classifiable)). Measurement time: During treatment and at 28 days.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

2

Target sample size:

234

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Ivis

Middle Name:

Cristina

Last Name:

Mendoza Hernandez

Specialty:

Master in Clinical trials and Pharmacology

Affiliation:

National Coordinating Clinical Trials Center (CENCEC)

Postal Address:

5ta A, No. 6020 e/ 60 y 62, Miramar, Playa.

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72164227, +53-72164228

Email :

ivis@cencec.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Gerardo

Middle Name:

Enrique

Last Name:

Guillen Nieto

Specialty:

Doctor in Biological Sciences. Director of Biomedical Research.

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

31 Ave e/ 158 and 190, Cubanacan, Playa

City:

Havana

País:

Cuba

Zip Code:

10600

Telephone:

+53-72718008 ext. 7204

Email :

gerardo.guillen@cigb.edu.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Salvador Allende Clinical Surgical Teaching Hospital

Diez de Octubre Clinical Surgical Teaching Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

28/03/2023

03/03/2023

Postal address of Ethic Committee :

Calzada del Cerro 1551 esq. Dominguez, ZC 12000, Havana, Cuba

Calzada 10 de Octubre 130 e/. Alejandro Ramirez y Agua Dulce. ZC 10300, Havana, Cuba

Telephone:

+53-78776354

+53-78786253

Correo electrónico:

sallende@infomed.sld.cu

hcqdir@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

20/10/2024

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000426

Date of Registration in Primary Registry:

06/07/2023

Record Verification Date:

2023/07/06

Next update date:

2024/07/06

Link to the spanish version:

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

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