Persistent Multiorgan Failure in Intensive Care Units

NCT03604731 | Completed DMC

• 1 other identifier: 201721
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

Multiorgan failure (MOF) as a result of any critical condition is a complex set of immunological and biochemical interactions leading to death in patients who are effectively subjected to primary resuscitation (correction of circulatory hypoxia in trauma and blood loss, restoration of blood circulation after operations with artificial circulation. The frequency of MOF varies depending on the primary diagnosis of a critical patient and, according to a number of authors, is 60% for sepsis, and for severe co-occurring trauma up to 40% of all critical patients. However, if one remembers that the MOF is verified only by clinical scales of assessing the severity of the patient's condition, which presupposes the presence of the already existing pathophysiological mechanisms of MOF as multi-organ dysfunction, it is possible to declare a 100% presence of MOF in all critical patients. The data of Graetz et al (2016) show that none of the available three variants of pathophysiological mechanisms (anomaly of microcirculation, persistent inflammation, immune suppression and catabolism, cellular hibernation and staning) have been unambiguously demonstrated, which also reflected the lack of effectiveness of methods therapy, proposed, based on the pathogenesis options for MOF. A so-called danger-model has a special place in the genesis of the persistence of the MOF, which justifies an active search for distress-associated and pathogen-associated molecular patterns for their objectification and probable elimination. The systemic inflammatory response in patients. included in the study, is not a primary infection. It is also important to determine the role of danger-associated molecular patterns (DAMP) in the genesis of immune suppression as the leading immunological phenotype of MOF in later periods and to evaluate the relationship between DAMP expression and immunosuppressive cells of monocyte origin. The study has a mixed (retro- and prospective) character.

Conditions

Systemic Inflammatory Response Syndrome; Sepsis; Multiorgan Failure

Keywords

Immunology, Suppression, Inflammation, Cardiac, Surgery

Outcome Measures

Primary Outcomes (1)

• Intensive Care Unit (ICU) 28 day mortality

  Mortality in ICU period within 28 day

  28 day

Secondary Outcomes (4)

• Free of multiorgan failure (MOF) days

  28 day

• Mechanical ventilation (MV) - dependent days

  28 day

• Renal Replacement Therapy (RRT) dependens

  28 day

• Assosiation of severity of ilness

  28 day

Study Arms (2)

Uncomplicated cardiac surgery patients

Patients after schedulled cardiac surgery procedures

Complicated cardiac surgery patients

Patients after schedulled cardiac surgery procedures complicated by multiorgan failure

Device: cytokine adsorbtion during extracorporeal circulation

Interventions

cytokine adsorbtion during extracorporeal circulation DEVICE

preventive use of cytokine adsorption and modulation of the cytokine response in the course of artificial circulation

Complicated cardiac surgery patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients operated on the heart and trunk vessels under conditions of artificial circulation (coronary artery bypass grafting, prosthetic / cardiac valve repair, operations on the aorta and its branches)

You may qualify if:

• patients after planned cardiac surgey
• informed consent

You may not qualify if:

• age less 18 and more then 80 years
• unplanned cardiac surgery

Sponsors & Collaborators

• Research Institute for Complex Problems of Cardiovascular Diseases, Russia: lead

Related Publications (6)

• Hotchkiss RS, Moldawer LL, Opal SM, Reinhart K, Turnbull IR, Vincent JL. Sepsis and septic shock. Nat Rev Dis Primers. 2016 Jun 30;2:16045. doi: 10.1038/nrdp.2016.45.

  PMID: 28117397 BACKGROUND

• Gaudilliere B, Angst MS, Hotchkiss RS. Deep Immune Profiling in Trauma and Sepsis: Flow Is the Way to Go! Crit Care Med. 2017 Sep;45(9):1577-1578. doi: 10.1097/CCM.0000000000002594. No abstract available.

  PMID: 28816846 BACKGROUND

• Graetz TJ, Hotchkiss RS. Sepsis: Preventing organ failure in sepsis - the search continues. Nat Rev Nephrol. 2017 Jan;13(1):5-6. doi: 10.1038/nrneph.2016.171. Epub 2016 Nov 21.

  PMID: 27867191 BACKGROUND

• Asehnoune K, Hotchkiss RS, Monneret G. Understanding why clinicians should care about danger-associated molecular patterns. Intensive Care Med. 2016 Apr;42(4):611-614. doi: 10.1007/s00134-015-4198-y. Epub 2016 Feb 24. No abstract available.

  PMID: 26912314 BACKGROUND

• Malard B, Lambert C, Kellum JA. In vitro comparison of the adsorption of inflammatory mediators by blood purification devices. Intensive Care Med Exp. 2018 May 4;6(1):12. doi: 10.1186/s40635-018-0177-2.

  PMID: 29728790 BACKGROUND

• Rosenthal M, Gabrielli A, Moore F. The evolution of nutritional support in long term ICU patients: from multisystem organ failure to persistent inflammation immunosuppression catabolism syndrome. Minerva Anestesiol. 2016 Jan;82(1):84-96. Epub 2015 Feb 20.

  PMID: 25697882 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood serum (cytokines, mit DNA)

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome; Sepsis; Multiple Organ Failure; Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: July 27, 2018
• Study Start: January 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: September 1, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share