Organ-substituting Technologies in the Treatment of Heart and Pulmonary Failure

NCT05042622 | Unknown

• 1 other identifier: version 1.1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The implementation of this project will improve the effectiveness of surgical treatment and reduce the level of complications and mortality among patients with heart failure and heart failure in the terminal stage. The goal of the study. Improvement of organ-substituting technologies in the treatment of heart and respiratory failure. Objectives of the study. Objective 1. To study the restoration of organ function during implantation of extracorporeal membrane oxygenation (ECMO), as an organ replacement, in cardiac and / or respiratory failure. Objective 2. To study the results of applying organ-substituting technologies in the treatment of sepsis.

Conditions

Acute Respiratory Distress Syndrome; Septic Shock; Sepsis

Keywords

Organ-substituting technologies; Heart failure; Pulmonary failure; Sepsis; Extracorporeal membrane oxygenation; Adsorber

Outcome Measures

Primary Outcomes (2)

• Difference of Cytokine response - ECMO patients

  Level of pro- and anti-inflammatory cytokines (IL-1, IL-6, IL-8, IL-10, tumor necrosis factor-alfa) before initiation of ECMO, 2 hours after initiation ECMO support, at explantation of ECMO support, 6-12-24 hours after explantation of ECMO support.

  6-24 hours

• Difference of Cytokine response - Patients with septic shock

  Level of procalcitonin, Level of C-reactive protein, Level of interleukin-1, Level of interleukin-6, Level of interleukin-8, Level of interleukin-10, Level of Tumor Necrosis Factor- αinterleukin-8, interleukin-10, Tumor Necrosis Factor- α at 24, 48 hours.

  24-48 hours of septic shock

Secondary Outcomes (14)

• Inflammatory reaction - Patients with septic shock

  6-24 hours

• Ventilator free days (VFD) - ECMO patients

  30 days

• Time to extubation from ventilation and explantation from ECMO - ECMO patients

  30 days

• Difference of d-dimers - ECMO patients

  24, 48, 72 hours

• Difference of Serum lactate - ECMO patients

  24, 48, 72 hours

Other Outcomes (6)

• Overall survival time

  30 days

• Days on intensive care unit (ICU)

  30 days

• Vasopressor dosage

  24, 48, 72 hours

Study Arms (6)

Cytokine adsorber patients on ECMO

EXPERIMENTAL

Cytokine adsorber filter will be installed into the (hemodialysis or cardiopulmonary bypass (CPB) (15 patients on ECMO)

Device: Cytokine adsorber filter

Cytokine adsorber patients with sepsis

EXPERIMENTAL

Cytokine adsorber filter will be installed into the (hemodialysis or cardiopulmonary bypass (CPB) (15 patients with sepsis)

Device: Cytokine adsorber filter

Extracorporeal hemoperfusion cartridge patients on ECMO

EXPERIMENTAL

Extracorporeal hemoperfusion cartridge will be installed into the (hemodialysis or cardiopulmonary bypass (CPB) (15 patients on ECMO)

Device: Extracorporeal hemoperfusion cartridge

Extracorporeal hemoperfusion cartridge patients with sepsis

EXPERIMENTAL

Extracorporeal hemoperfusion cartridge will be installed into the (hemodialysis or cardiopulmonary bypass (CPB) (15 patients with sepsis)

Device: Extracorporeal hemoperfusion cartridge

Control (subgroups)1

NO INTERVENTION

No filter will be installed into the ECMO in this study group (15 patients)

Control (subgroups) 2

NO INTERVENTION

No filter will be installed into the patient with sepsis (15 patients)

Interventions

Cytokine adsorber filter DEVICE

• Intervention group #1 a cytokine adsorber will be used (30 patients): patients on ECMO - subgroup A; septic patients - subgroup B.

Cytokine adsorber patients on ECMO; Cytokine adsorber patients with sepsis

Extracorporeal hemoperfusion cartridge DEVICE

• Intervention group #2 an extracorporeal hemoperfusion cartridge will be used (30 patients): patients on ECMO - subgroup C, septic patients - subgroup D.

Extracorporeal hemoperfusion cartridge patients on ECMO; Extracorporeal hemoperfusion cartridge patients with sepsis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ICU patients with ECMO:
• Hemodynamic support with vasopressors
• Procalcitonin level ≥ 1 ng/ml
• Invasive hemodynamic monitoring
• Written informed content
• ICU patients with the septic shock of medical origin:
• Signs of hypoperfusion: serum lactate \>2 mmol/L, low central venous oxygen saturation (ScvO2) (\<70%) or high ScvO2 (\>85%), metabolic acidosis, oligo-anuria, high venous-to-arterial CO2-gap (dCO2 \>6 mm Hg)
• Hemodynamic support with vasopressors
• Procalcitonin level ≥ 1 ng/ml
• Invasive hemodynamic monitoring
• Written informed content

You may not qualify if:

• ICU patients with ECMO:
• age \< 18 years
• acute liver or kidney failure straight before transplantation
• the patient declines to participate in the study
• ICU patients with the septic shock of medical origin:
• Patients under 18 years
• Pregnancy (bHCG test positivity)
• Surgical intervention in context with the septic insult New York Heart Association IV heart failure
• Acute coronary syndrome
• Acute hematological malignancies
• Immunosuppression, systemic steroid therapy (\>10mg prednisolone/day)
• Human immunodeficiency virus infection (HIV) and active AIDS
• Patients with donated organs
• Thrombocytopenia (\<20.000/ml)
• More than 10%-of body surface area with third-degree burn

Sponsors & Collaborators

• National Research Center for Cardiac Surgery, Kazakhstan: lead
• Ministry of Education and Science, Republic of Kazakhstan: collaborator

Study Sites (1)

National Research Center for Cardiac Surgery

Astana, 010000, Kazakhstan

RECRUITING

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MeSH Terms

Conditions

Respiratory Distress Syndrome; Shock, Septic; Sepsis; Heart Failure

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Heart Diseases; Cardiovascular Diseases

Study Officials

• Timur Lesbekov, PhD, MD

  National research Center for Cardiac Surgery JSC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rymbay Kaliyev, MD

CONTACT

+77055965060; rymbay@mail.ru

Zhuldyz Nurmykhametova, MD

CONTACT

+77781115377; zhyzik-nur@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Cardiac Surgery

Model Details: Study Design Study Type: Interventional (Clinical Trial) Estimated Enrollment: 90 Participants Allocation: randomized Interventional Model: Parallel assignment Masking: None (Open Label)

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: September 13, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 01.01.2021 - 31.12.2023
• Access Criteria: All patients will receive voluntary informed consent of the established sample with permission to use clinical data for scientific purposes. In addition, the study will be strictly controlled by researchers for the absence of plagiarism, falsification and fabrication of data in order to achieve the most ethical conduct of the study. The obtained patient data will be kept strictly confidential, ensuring privacy by strictly limited access to data, de-identification of data and destruction after the end of the study.

Locations

KA (1)