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Completed

NCT Number: NCT05070819

Atrial Natriuretic Peptide in Assessing Fluid Status

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

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Key information

Conditions

Fluid Overload Cardiac Disease Cardiac Output, High Cardiac Output, Low Cardiovascular Diseases Edema Fluid Loss Heart Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Volume Overload

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Petrovsky Research National Centre of Surgery (Petrovsky NRCS)

Moscow, 119991, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

pro-ANP

Diagnostic Test

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

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

Secondary outcomes

  1. Postoperative Complications

    Time frame: up to 10 days

    Total amount of various postoperative complications

  2. Mortality

    Time frame: up to 10 days

    Mortality rate

  3. Multiorgan Failure

    Time frame: up to 10 days

    Number of more than 2 organs failure

  4. Respiratory Failure

    Time frame: up to 10 days

    Number of patients who require prolonged and/or repeated artificial lung ventilation

  5. Renal Failure

    Time frame: up to 10 days

    Number of patients who require extracorporeal detoxication

  6. Heart Failure

    Time frame: up to 10 days

    Need in medicamental cardiotonic support more than 1 day

  7. Circulatory Insufficiency

    Time frame: up to 10 days

    Need in medicamental vasopressor support more than 1 day

  8. Infection Rate

    Time frame: up to 10 days

    Number of patients who develop systemic infection and/or operation wound infection

  9. Length of Intensive Care Stay

    Time frame: up to 10 days

    Duration of summarized length in ICU, including readmission to ICU

Sponsors and collaborators

Lead sponsor

Petrovsky National Research Centre of Surgery

Other

Registry information

Official study title

Role of Atrial Natriuretic Peptide in Assessing of Fluid Status in Cardiac Surgery Patients

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 7, 2021
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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