Atrial Natriuretic Peptide in Assessing Fluid Status

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.

Study Overview

• Status: Completed
• Conditions: Fluid Overload; Cardiac Disease; Cardiac Output, Low; Volume Overload; Cardiac Output, High; Fluid Loss
• Intervention / Treatment: Diagnostic test: pro-ANP

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119991
    • Petrovsky Research National Centre of Surgery (Petrovsky NRCS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

CABG, one-, two valve repair/replacement, ascending aorta, aortic arch replacement, ASD/AVD closure, septal myectomy

Exclusion Criteria:

1. Atrial fibrillation, atrial flutter, frequent ventricular and supraventricular arrythmias
2. EFLV < 50%
3. Pulmonary hypertension > 2 st
4. CKD > C3 (GFR < 30)
5. Redo surgery
6. Left atrium volume > 150 ml
7. LV EDV > 250 ml

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cardiac surgery patients; After admission to OR and arterial catheter is placed the pro-ANP probe is obtained.; After anesthesia induction, trachea intubation before Teboul' test pro-ANP is obtained; At the end of Teboul' test when lower limbs are lifted; 30 minutes of CPB; End of CPB; End of volume transition from CPB circuit to patient; Before Teboul' test at the end of surgery; End of Teboul' test when lower limbs are lifted

Diagnostic test: pro-ANP; pro-ANP samples and fluid status assessment with functional tests (Teboul test) will be used 8 times intraoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality rate	up to 10 days
Postoperative Complications	Total amount of various postoperative complications	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
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
Length of Intensive Care Stay	Duration of summarized length in ICU, including readmission to ICU	up to 10 days

Collaborators and Investigators

• Sponsor: Petrovsky National Research Centre of Surgery
• Investigators: Principal Investigator: Boris Akselrod, Ph.D, Petrovsky NRCS

Publications and helpful links

Helpful Links

• Influence of volemic status on serum atrial natriuretic peptide in cardiac surgical patients

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2021
• Primary Completion (Actual): March 28, 2022
• Study Completion (Actual): April 7, 2022

Study Registration Dates

• First Submitted: September 27, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): October 7, 2021

Study Record Updates

• Last Update Posted (Actual): June 8, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: cardiac surgery; fluid responsiveness; cardiac output; hemodynamic monitoring; stroke volume variation; functional test; fluid status; pro-ANP; volemic status; teboul test
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Cardiac Output, Low; Cardiac Output, High
• Other Study ID Numbers: 0394227092021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No