Validation of Hematological Indices

NCT06476171 | Recruiting

• 1 other identifier: 6
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis of the study is that hematological indices (neutrophil to lymphocyte ratio, platelet to lymphocyte ratio and systemic index of inflammation) may be predictors of infectious complications and multiple organ dysfunction in patients after cardiac surgery.

Conditions

Multiple Organ Dysfunction; Sepsis; Pneumonia; Wound Infection

Keywords

Multiple Organ Dysfunction; Sepsis; cardiac surgery; hematological indices

Outcome Measures

Primary Outcomes (1)

• Number of patients with onset of complications of any type in the postoperative period

  Recording by the attending physician of the occurrence of a complication

  Up to 12 weeks

Secondary Outcomes (5)

• Changes in the levels of other biomarkers often used in clinical practice

  Up to 1 week

• Number of patients with nosocomial pneumonia

  Up to 12 weeks

• Number of patients with wound infection

  Up to 12 weeks

• Number of patients with multiple organ dysfunction

  Up to 12 weeks

• Number of patients with sepsis

  Up to 12 weeks

Study Arms (2)

Control Group

EXPERIMENTAL

A group of patients whose postoperative period proceeded without complications, in connection with which they were transferred to the specialized department within 1-2 days.

Diagnostic Test: Determination of the level of the studied biomarkers

Group of patients with complications

EXPERIMENTAL

Patients who had postoperative complications: pneumonia, wound infection, sepsis, multiple organ dysfunction.

Diagnostic Test: Determination of the level of the studied biomarkers

Interventions

Determination of the level of the studied biomarkers DIAGNOSTIC_TEST

Determination of the level of hematological indices based on a general blood test; Determination of the levels of the following biomarkers: isolation of neutrophils from the blood using the gradient centrifugation method; assessment using enzyme immunoassay (ELISA) of the content of neutrophil elastase in the supernatant; myeloperoxidase, ELISA; lactoferrin, ELISA; interleukin -1ß,17,10,6, ELISA; presepsin, ELISA; endothelin, ELISA; lipopolysaccharide, LAL test; lipopolysaccharide binding protein, ELISA; NETs release, immunofluorescence method; the number of neutrophils expressing PDL-1, flow cytofluorimetry method; procalcitonin in human plasma and serum, VIDAS B.R.A.H.M.S. PCT; ferritin, reagent for determination (FERRITIN); lactate dehydrogenase, reagent for determination of QSR6128;Endotoxin Activity Assay, chemiluminescent immunodiagnostics.

Control Group; Group of patients with complications

Eligibility Criteria

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

You may qualify if:

• age from 18 to 80 years
• cardiac surgery
• operation in the conditions of cardiopulmonary bypass
• availability of voluntary informed consent of the patient to participate in the study

You may not qualify if:

• refusal of the patient from the study
• transfer of the patient to another medical institution

Sponsors & Collaborators

• Petrovsky National Research Centre of Surgery: lead

Study Sites (1)

Petrovsky National Reasearch Centre of Surgery

Moscow, 119991, Russia

RECRUITING

MeSH Terms

Conditions

Sepsis; Pneumonia; Wound Infection

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Maxim A. Babaev, D.M.

  Petrovsky NRCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maxim A. Babaev, D.M.

CONTACT

89160269066; maxbabaev@mail.ru

Oxana O. Grin

CONTACT

89168748565; grin_oksana@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: June 26, 2024
• Study Start: June 19, 2023
• Primary Completion: November 1, 2025
• Study Completion: December 30, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

RU (1)