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Biomarkers can play a significant role in fluid status assessment intraoperatively.
Routinely intraoperatively the fluid status assessment is based on central venous pressure and other parameters. Nevertheless, the minority of anesthesiologists use continous dynamic parameters like pulse pressure variation, stroke volume variation and other to manage fluid status. There's a fast acting biomarker that can help anesthesiologist to diagnose and manage the volemic status and possibly guide the infusion therapy better.
Pro-ANP is a biomarker that reacts on atria strain and can be used in volemic status assessment in cardiac surgery patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac surgery patients | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pro-ANP | Diagnostic Test | pro-ANP samples and fluid status assessment with functional tests (Teboul test) will be used 8 times intraoperatively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Pro-ANP Twofold Raise by the End of Surgery | To assess the atria strain and consequent rise of pro-ANP by the end of surgery | intraoperatively |
| Number of Patients With Pro-ANP Increase > 10% by the PLR Maneuver | According to positive PLR the assessment of pro-ANP consequent raise | intraoperative |
| Number of Patients With Cardiac Index Rise > 10% After Passive Leg Raising Maneuver | Using Massimo vigileo hard- and software the first assessment of cardiac index was made before Teboul test after the trachea intubation. After 10 minutes of passive leg raising maneuver second assessment. If raise in cardiac index above 10 percent was detected the patient was considered a responder. If not - non-responder. | 10 minutes of PLR test |
| Number of Patients With Pro-ANP Increase > 10% by the PLR Maneuver at the End of Surgery | Using Massimo vigileo hard- and software the assessment of cardiac index was made before Teboul test at the end of surgery before leaving the operating room. After 10 minutes of passive leg raising maneuver second assessment. If raise in cardiac index above 10 percent was detected the patient was considered a responder. If not - non-responder. | 10 minutes of PLR test |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Complications | Total amount of various postoperative complications | up to 10 days |
| Mortality | Mortality rate | up to 10 days |
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Inclusion Criteria:
CABG, one-, two valve repair/replacement, ascending aorta, aortic arch replacement, ASD/AVD closure, septal myectomy
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boris Akselrod, Ph.D | Petrovsky NRCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Petrovsky Research National Centre of Surgery (Petrovsky NRCS) | Moscow | 119991 | Russia |
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| Label | URL |
|---|---|
| Influence of volemic status on serum atrial natriuretic peptide in cardiac surgical patients | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cardiac Surgery Patients |
pro-ANP: pro-ANP samples and fluid status assessment with functional tests (Teboul test) will be used 8 times intraoperatively. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cardiac Surgery Patients | 30 patients enrolled in a study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Pro-ANP Twofold Raise by the End of Surgery | To assess the atria strain and consequent rise of pro-ANP by the end of surgery | Posted | Count of Participants | Participants | intraoperatively |
|
|
10 days postoperative
All-cause mortality: 0/30
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cardiac Surgery Patients | 30 patients enrolled in a study | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Artem Gubko | Petrovsky NRCS | +79684241490 | gubko@artvig.ru |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 15, 2021 | Jan 24, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004487 | Edema |
| D006331 | Heart Diseases |
| D002303 | Cardiac Output, Low |
| D016534 | Cardiac Output, High |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002318 | Cardiovascular Diseases |
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| Multiorgan Failure | Number of more than 2 organs failure | up to 10 days |
| Respiratory Failure | Number of patients who require prolonged and/or repeated artificial lung ventilation | up to 10 days |
| Renal Failure | Number of patients who require extracorporeal detoxication | up to 10 days |
| Heart Failure | Need in medicamental cardiotonic support more than 1 day | up to 10 days |
| Circulatory Insufficiency | Need in medicamental vasopressor support more than 1 day | up to 10 days |
| Infection Rate | Number of patients who develop systemic infection and/or operation wound infection | up to 10 days |
| Length of Intensive Care Stay | Duration of summarized length in ICU, including readmission to ICU | up to 10 days |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body surface area, м² | Mean | Standard Deviation | square meters |
|
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| Primary | Number of Patients With Pro-ANP Increase > 10% by the PLR Maneuver | According to positive PLR the assessment of pro-ANP consequent raise | Posted | Count of Participants | Participants | intraoperative |
|
|
|
| Primary | Number of Patients With Cardiac Index Rise > 10% After Passive Leg Raising Maneuver | Using Massimo vigileo hard- and software the first assessment of cardiac index was made before Teboul test after the trachea intubation. After 10 minutes of passive leg raising maneuver second assessment. If raise in cardiac index above 10 percent was detected the patient was considered a responder. If not - non-responder. | Posted | Number | Responders | 10 minutes of PLR test |
|
|
|
| Primary | Number of Patients With Pro-ANP Increase > 10% by the PLR Maneuver at the End of Surgery | Using Massimo vigileo hard- and software the assessment of cardiac index was made before Teboul test at the end of surgery before leaving the operating room. After 10 minutes of passive leg raising maneuver second assessment. If raise in cardiac index above 10 percent was detected the patient was considered a responder. If not - non-responder. | Posted | Number | Responders | 10 minutes of PLR test |
|
|
|
| Secondary | Postoperative Complications | Total amount of various postoperative complications | Posted | Count of Participants | Participants | up to 10 days |
|
|
|
| Secondary | Mortality | Mortality rate | Posted | Count of Participants | Participants | up to 10 days |
|
|
|
| Secondary | Multiorgan Failure | Number of more than 2 organs failure | Posted | Count of Participants | Participants | up to 10 days |
|
|
|
| Secondary | Respiratory Failure | Number of patients who require prolonged and/or repeated artificial lung ventilation | Posted | Count of Participants | Participants | up to 10 days |
|
|
|
| Secondary | Renal Failure | Number of patients who require extracorporeal detoxication | Posted | Count of Participants | Participants | up to 10 days |
|
|
|
| Secondary | Heart Failure | Need in medicamental cardiotonic support more than 1 day | Posted | Count of Participants | Participants | up to 10 days |
|
|
|
| Secondary | Circulatory Insufficiency | Need in medicamental vasopressor support more than 1 day | Posted | Count of Participants | Participants | up to 10 days |
|
|
|
| Secondary | Infection Rate | Number of patients who develop systemic infection and/or operation wound infection | Posted | Count of Participants | Participants | up to 10 days |
|
|
|
| Secondary | Length of Intensive Care Stay | Duration of summarized length in ICU, including readmission to ICU | Posted | Median | Inter-Quartile Range | hours | up to 10 days |
|
|
|
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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