Fluid OverloadNCT05070819
Atrial Natriuretic Peptide in Assessing Fluid Status
A study testing pro-ANP in people with Fluid Overload and Fluid Loss, run by Petrovsky National Research Centre of Surgery at 1 site in Russia.
Trial summary
Biomarkers can play a significant role in fluid status assessment intraoperatively. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fluid Overload, Fluid Loss, Volume Overload
- What is being tested?
- pro-ANP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 23 Sep 2021to 7 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CABG, one-, two valve repair/replacement, ascending aorta, aortic arch replacement, ASD/AVD closure, septal myectomy
Who cannot join
- Atrial fibrillation, atrial flutter, frequent ventricular and supraventricular arrythmias
- EFLV < 50%
- Pulmonary hypertension > 2 st
- CKD > C3 (GFR < 30)
- Redo surgery
- Left atrium volume > 150 ml
- LV EDV > 250 ml
Trial locations and contacts
1 site in 1 country.
Russia1 site
Petrovsky Research National Centre of Surgery (Petrovsky NRCS)
Moscow, 119991
About this study
Official title: Role of Atrial Natriuretic Peptide in Assessing of Fluid Status in Cardiac Surgery Patients
Biomarkers can play a significant role in fluid status assessment intraoperatively.
Read the detailed description
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.
- Conditions
- Fluid Overload, Fluid Loss, Volume Overload, Cardiac Disease, Cardiac Output, Low, Cardiac Output, High
- Being tested
- pro-ANP
- Keywords
- fluid responsiveness, fluid status, cardiac surgery, volemic status, pro-ANP, hemodynamic monitoring, functional test, teboul test, stroke volume variation, cardiac output
- Medical subject headings
- Edema, Heart Diseases, Cardiac Output, Low, Cardiac Output, High
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pro-ANPDiagnostic test
pro-ANP samples and fluid status assessment with functional tests (Teboul test) will be used 8 times intraoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac surgery patients | Experimental | 1. After admission to OR and arterial catheter is placed the pro-ANP probe is obtained.
2. After anesthesia induction, trachea intubation before Teboul' test pro-ANP is obtained
3. At the end of Teboul' test when lower limbs are lifted
4. 30 minutes of CPB
5. End of CPB
6. End of volume transition from CPB circuit to patient
7. Before Teboul' test at the end of surgery
8. End of Teboul' test when lower limbs are lifted Receives: Diagnostic Test: pro-ANP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: intraoperatively
Number of Patients With Pro-ANP Increase > 10% by the PLR Maneuver
According to positive PLR the assessment of pro-ANP consequent raise
Measured: 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.
Measured: 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.
Measured: 10 minutes of PLR test
Secondary outcomes (9)
Postoperative Complications
Total amount of various postoperative complications
Measured: up to 10 days
Mortality
Mortality rate
Measured: up to 10 days
Multiorgan Failure
Number of more than 2 organs failure
Measured: up to 10 days
Respiratory Failure
Number of patients who require prolonged and/or repeated artificial lung ventilation
Measured: up to 10 days
Renal Failure
Number of patients who require extracorporeal detoxication
Measured: up to 10 days
Heart Failure
Need in medicamental cardiotonic support more than 1 day
Measured: up to 10 days
Circulatory Insufficiency
Need in medicamental vasopressor support more than 1 day
Measured: up to 10 days
Infection Rate
Number of patients who develop systemic infection and/or operation wound infection
Measured: up to 10 days
Length of Intensive Care Stay
Duration of summarized length in ICU, including readmission to ICU
Measured: up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start23 Sep 2021
- Primary completion28 Mar 2022
- Study completion7 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fluid OverloadStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Petrovsky National Research Centre of Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Boris Akselrod, Ph.D, Principal investigator, Petrovsky NRCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070819
- Sponsor's protocol ID
- 0394227092021
- Status last verified
- Jun 2025
- First submitted
- 27 Sep 2021
- Last updated
- 8 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Atrial Natriuretic Peptide in Assessing of Fluid Status in Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT05070819
- Acronym / sponsor ID
- 0394227092021
- Conditions
- Fluid Overload, Fluid Loss, Volume Overload, Cardiac Disease, Cardiac Output, Low, Cardiac Output, High
- Keywords
- fluid responsiveness, fluid status, cardiac surgery, volemic status, pro-ANP, hemodynamic monitoring, functional test, teboul test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Petrovsky National Research Centre of SurgeryUniversity, hospital or other
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 7 Apr 2022 (actual)
- First posted
- 7 Oct 2021 (actual)
- Results
- Posted 8 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Biomarkers can play a significant role in fluid status assessment intraoperatively.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac surgery patients | Experimental | Diagnostic Test: pro-ANP1. After admission to OR and arterial catheter is placed the pro-ANP probe is obtained. 2. After anesthesia induction, trachea intubation before Teboul' test pro-ANP is obtained 3. At the end of Teboul' test when lower limbs are lifted 4. 30 minutes of CPB 5. End of CPB 6. End of volume transition from CPB circuit to patient 7. Before Teboul' test at the end of surgery 8. End of Teboul' test when lower limbs are lifted |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- CABG, one-, two valve repair/replacement, ascending aorta, aortic arch replacement, ASD/AVD closure, septal myectomy
Key exclusion criteria (7 listed)
- Atrial fibrillation, atrial flutter, frequent ventricular and supraventricular arrythmias
- EFLV < 50%
- Pulmonary hypertension > 2 st
- CKD > C3 (GFR < 30)
- Redo surgery
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 |
|---|---|---|
| pro-ANPpro-ANP samples and fluid status assessment with functional tests (Teboul test) will be used 8 times intraoperatively. | Diagnostic test | Cardiac surgery patients |
Primary outcome
Number of Patients With Pro-ANP Twofold Raise by the End of Surgery
Time frame: intraoperatively
To assess the atria strain and consequent rise of pro-ANP by the end of surgery
Number of Patients With Pro-ANP Increase > 10% by the PLR Maneuver
Time frame: intraoperative
According to positive PLR the assessment of pro-ANP consequent raise
Number of Patients With Cardiac Index Rise > 10% After Passive Leg Raising Maneuver
Time frame: 10 minutes of PLR test
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.
Number of Patients With Pro-ANP Increase > 10% by the PLR Maneuver at the End of Surgery
Time frame: 10 minutes of PLR test
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.
9 secondary outcomes
Postoperative Complications
Time frame: up to 10 days
Mortality
Time frame: up to 10 days
Multiorgan Failure
Time frame: up to 10 days
Respiratory Failure
Time frame: up to 10 days
Renal Failure
Time frame: up to 10 days
Heart Failure
Time frame: up to 10 days
Circulatory Insufficiency
Time frame: up to 10 days
Infection Rate
Time frame: up to 10 days
Length of Intensive Care Stay
Time frame: up to 10 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Influence of volemic status on serum atrial natriuretic peptide in cardiac surgical patientsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Boris Akselrod, Ph.D 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 pro-ANP in people with Fluid Overload and Fluid Loss, 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 8 Jun 2025. 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?
Yes. Results are posted in the registry (first posted 8 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Pro-ANP Twofold Raise by the End of Surgery (time frame: intraoperatively). The study lists 4 primary outcomes in all. 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 8 Jun 2025.