Validation of Hematological Indices
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Determination of the level of the studied biomarkers.
- Who it may be relevant to
- Registry conditions: Multiple Organ Dysfunction, Sepsis, Pneumonia, Wound Infection. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Validation of Hematological Indices as Prognostic Markers of Inflammatory Complications and Multiple Organ Dysfunction in Cardiac Surgery Patients.
Overview
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.
Interventions
- 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 protei
Primary outcome measures
- Number of patients with onset of complications of any type in the postoperative period [Time frame: Up to 12 weeks]
Secondary outcome measures (5)
- Changes in the levels of other biomarkers often used in clinical practice [Time frame: Up to 1 week]
- Number of patients with nosocomial pneumonia [Time frame: Up to 12 weeks]
- Number of patients with wound infection [Time frame: Up to 12 weeks]
- Number of patients with multiple organ dysfunction [Time frame: Up to 12 weeks]
- Number of patients with sepsis [Time frame: Up to 12 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Russia · 1 center
- Petrovsky National Reasearch Centre of Surgery — Moscow
Identifiers
NCT: NCT06476171 · 6