Multiple Organ DysfunctionNCT06476171
Validation of Hematological Indices
A study testing Determination of the level of the studied biomarkers in people with Multiple Organ Dysfunction and Sepsis, run by Petrovsky National Research Centre of Surgery at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Organ Dysfunction, Sepsis, Pneumonia
- What is being tested?
- Determination of the level of the studied biomarkers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- 19 Jun 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- refusal of the patient from the study
- transfer of the patient to another medical institution
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Petrovsky National Reasearch Centre of Surgery
Moscow, 119991
OXANA GRIN', 89168748586, grin_oksana@mail.ru
MAXIM BABAEV, D.М.Sc., 89160269066, maxbabaev@mail.ru
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Organ Dysfunction, Sepsis, Pneumonia, Wound Infection
- Being tested
- Determination of the level of the studied biomarkers
- Keywords
- Multiple Organ Dysfunction, Sepsis, cardiac surgery, hematological indices
- Medical subject headings
- Sepsis, Pneumonia, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determination of the level of the studied biomarkersDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | 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. Receives: Diagnostic Test: Determination of the level of the studied biomarkers |
| Group of patients with complications | Experimental | Patients who had postoperative complications: pneumonia, wound infection, sepsis, multiple organ dysfunction. Receives: Diagnostic Test: Determination of the level of the studied biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 12 weeks
Secondary outcomes (5)
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
Measured: 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%).
Measured: 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.
Measured: 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
Measured: 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.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start19 Jun 2023
- Primary completion1 Nov 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Organ DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Petrovsky National Research Centre of Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxim A. Babaev, D.M., Principal investigator, Petrovsky NRCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476171
- Sponsor's protocol ID
- 6
- Status last verified
- Nov 2024
- First submitted
- 5 Mar 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Hematological Indices as Prognostic Markers of Inflammatory Complications and Multiple Organ Dysfunction in Cardiac Surgery Patients.
- ClinicalTrials.gov ID
- NCT06476171
- Acronym / sponsor ID
- 6
- Conditions
- Multiple Organ Dysfunction, Sepsis, Pneumonia, Wound Infection
- Keywords
- Multiple Organ Dysfunction, Sepsis, cardiac surgery, hematological indices
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Petrovsky National Research Centre of SurgeryUniversity, hospital or other
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Diagnostic Test: Determination of the level of the studied biomarkersA group of patients whose postoperative period proceeded without complications, in connection with which they were transferred to the specialized department within 1-2 days. |
| Group of patients with complications | Experimental | Diagnostic Test: Determination of the level of the studied biomarkersPatients who had postoperative complications: pneumonia, wound infection, sepsis, multiple organ dysfunction. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- refusal of the patient from the study
- transfer of the patient to another medical institution
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Determination of the level of the studied biomarkersDetermination 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. | Diagnostic test | Control Group, Group of patients with complications |
Primary outcome
Number of patients with onset of complications of any type in the postoperative period
Time frame: Up to 12 weeks
Recording by the attending physician of the occurrence of a complication
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maxim A. Babaev, D.M. principal investigator
Petrovsky NRCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Determination of the level of the studied biomarkers in people with Multiple Organ Dysfunction and Sepsis, run by Petrovsky National Research Centre of Surgery at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maxim A. Babaev, D.M. (89160269066, maxbabaev@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with onset of complications of any type in the postoperative period (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.