Clinical trial NCT06476171: Validation of Hematological Indices
Official title: Validation of Hematological Indices as Prognostic Markers of Inflammatory Complications and Multiple Organ Dysfunction in Cardiac Surgery Patients.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Organ Dysfunction
Sepsis
Pneumonia
Wound Infection
Keywords: Multiple Organ Dysfunction
Sepsis
cardiac surgery
hematological indices
Lead sponsor: Petrovsky National Research Centre of Surgery
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with onset of complications of any type in the postoperative period
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Changes in the levels of other biomarkers often used in clinical practice
timeFrame: Up to 1 week
measure: Number of patients with nosocomial pneumonia
timeFrame: Up to 12 weeks
measure: Number of patients with wound infection
timeFrame: Up to 12 weeks
measure: Number of patients with multiple organ dysfunction
timeFrame: Up to 12 weeks
measure: Number of patients with sepsis
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Petrovsky National Reasearch Centre of Surgery
Study officials:
affiliation: Petrovsky NRCS
name: Maxim A. Babaev, D.M.
role: PRINCIPAL_INVESTIGATOR
References: