Ignite Creation Date:
2024-07-17 @ 11:10 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476171
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-03-05
Brief Title:
Validation of Hematological Indices
Sponsor:
Petrovsky National Research Centre of Surgery
Organization:
Petrovsky National Research Centre of Surgery
Study Overview
Official Title:
Validation of Hematological Indices as Prognostic Markers of Inflammatory Complications and Multiple Organ Dysfunction in Cardiac Surgery Patients
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None