Validation of Hematological Indices
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPetrovsky National Research Centre of Surgery
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
refusal of the patient from the study
transfer of the patient to another medical institution
Trial design
Design model
Parallel
Treatments tested in this trial
Determination of the level of the studied biomarkers
Diagnostic testDetermination 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Control GroupExperimental treatment 1 intervention
Group B: Group of patients with complicationsExperimental treatment 1 intervention
Trial outcomes
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
Time frame
Up to 12 weeksSecondary outcomes
1
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
Time frame
Up to 1 week2
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%).
Time frame
Up to 12 weeks3
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.
Time frame
Up to 12 weeks4
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
Time frame
Up to 12 weeksSponsors and contacts
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Source ClinicalTrials.gov