Validation of Hematological Indices

Validation of Hematological Indices as Prognostic Markers of Inflammatory Complications and Multiple Organ Dysfunction in Cardiac Surgery Patients.

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.

Study Overview

• Status: Recruiting
• Conditions: Pneumonia; Sepsis; Wound Infection; Multiple Organ Dysfunction
• Intervention / Treatment: Diagnostic test: Determination of the level of the studied biomarkers

Detailed Description

The hematological index validation study is a single-center interventional prospective study. The aim of the study: to determine the average and threshold values of hematological indices in patients with cardiac surgery before surgery and in the early postoperative period; to determine the levels of hematological indices that indicate an unfavorable course of the postoperative period and may be predictors of infection or multiple organ dysfunction. The study will include 200 patients who are shown cardiac surgery. Blood samples will be collected before the study at three stages: before the operation, on the first day after the operation and on the third day after the operation. Based on the hematological indices studied (NLR, PLR, SII), other biomarkers often used in clinical practice (presepsin, procalcitonin, interleukins, etc.) will also be determined. Each patient will be monitored throughout the perioperative period until the patient is discharged from the hospital by the study participants, in the future all records from the medical history will also be analyzed., including data from instrumental and laboratory studies, consultations of specialists. Based on these data, patients will be divided into groups depending on the presence of complications and their nature. Data concerning demographic indicators, the levels of biomarkers studied and the course of postoperative will be stored in the Exel program. Statistical analysis is planned to be carried out in the IBM SPSS Statistics program. For each quantitative indicator, the nature of the distribution will be determined using the Kolmogorov-Smirnov criterion. All quantitative data with a normal distribution will be presented in the form of mean and standard deviation; with a distribution other than normal - in the form of a median (Q2) and an interquartile span (Q1; Q3). Parametric and nonparametric criteria will be used to assess the differences between the samples, depending on the nature of the distribution. It is planned to complete the correlation analysis performed; assessment of the influence of independent variables on dependent, encoded binary, using logistic regression; construction of ROC curves. It is planned to calculate the odds ratio (OR), 95% confidence interval (CI) and the significance of the influence of p. In all cases, the results of statistical analysis are considered significant at p < 0.05.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maxim A. Babaev, D.M.; Phone Number: 89160269066; Email: maxbabaev@mail.ru
• Study Contact Backup: Name: Oxana O. Grin; Phone Number: 89168748565; Email: grin_oksana@mail.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119991
    • Recruiting
    • Petrovsky National Reasearch Centre of Surgery
    • Contact: OXANA GRIN'; Phone Number: 89168748586; Email: grin_oksana@mail.ru
    • Contact: MAXIM BABAEV, D.М.Sc.; Phone Number: 89160269066; Email: maxbabaev@mail.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control Group; 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; 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.
Experimental: Group of patients with complications; Patients who had postoperative complications: pneumonia, wound infection, sepsis, multiple organ dysfunction.	Diagnostic test: Determination of the level of the studied biomarkers; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the levels of other biomarkers often used in clinical practice	neutrophil elastase; myeloperoxidase; lactoferrin; interleukins -1β,17,10,6; presepsin; endothelin; lipopolysaccharide; lipopolysaccharide binding protein; procalcitonin; lactoferrin; interleukins -1β,17,10,6; presepsin; endothelin; lipopolysaccharide; lipopolysaccharide binding protein; procalcitonin; ferritin ; lactate dehydrogenase, tumor necrosis factor - alpha; Endotoxin Activity Assay	Up to 1 week
Number of patients with nosocomial pneumonia	In accordance with national clinical guidelines, the diagnosis of pneumonia was made with the appearance of fresh focal infiltrative changes in the lungs according to X-ray examination data in combination with two or more clinical and laboratory signs (acute fever 38,0 ° C and higher; cough with sputum; physical signs - focus of crepitation/small bubbly wheezing, bronchial respiration, shortening of percussion sound; leukocytosis > 10 x 109 /l and/or rod shift > 10%).	Up to 12 weeks
Number of patients with wound infection	The diagnosis of wound infection is established jointly with surgeons on the basis of examination of the postoperative wound during dressing and bacteriological examination of the discharge from the wound.	Up to 12 weeks
Number of patients with multiple organ dysfunction	With the dysfunction of two or more functional systems (cardiovascular, respiratory, renal-hepatic), the syndrome of multiple organ dysfunction was established	Up to 12 weeks
Number of patients with sepsis	If there is a focus of infection or suspected infection in combination with multiple organ dysfunction (+ 2 points on the SOFA scale), sepsis is diagnosed.	Up to 12 weeks

Collaborators and Investigators

• Sponsor: Petrovsky National Research Centre of Surgery
• Investigators: Principal Investigator: Maxim A. Babaev, D.M., Petrovsky NRCS

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: June 20, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: cardiac surgery; Sepsis; Multiple Organ Dysfunction; hematological indices
• Additional Relevant MeSH Terms: Infections; Wound Infection
• Other Study ID Numbers: 6

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No