Atrial Natriuretic Peptide in Assessing Fluid Status

NCT05070819 | Completed Results DMC

• 1 other identifier: 0394227092021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Biomarkers can play a significant role in fluid status assessment intraoperatively.

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; stroke volume variation; cardiac output

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Postoperative Complications

  up to 10 days

• Mortality

  up to 10 days

• Multiorgan Failure

  up to 10 days

• Respiratory Failure

  up to 10 days

• Renal Failure

  up to 10 days

Study Arms (1)

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

Diagnostic Test: pro-ANP

Interventions

pro-ANP DIAGNOSTIC_TEST

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

Cardiac surgery patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Petrovsky National Research Centre of Surgery: lead

Study Sites (1)

Petrovsky Research National Centre of Surgery (Petrovsky NRCS)

Moscow, 119991, Russia

Location

Related Links

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

MeSH Terms

Conditions

Edema; Heart Diseases; Cardiac Output, Low; Cardiac Output, High

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Artem Gubko
• Organization: Petrovsky NRCS

gubko@artvig.ru

+79684241490

Study Officials

• Boris Akselrod, Ph.D

  Petrovsky NRCS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 7, 2021
• Study Start: September 23, 2021
• Primary Completion: March 28, 2022
• Study Completion: April 7, 2022
• Last Updated: June 8, 2025
• Results First Posted: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)