Atrial Natriuretic Peptide in Assessing Fluid Status

Not Applicable

Completed

• Conditions: Volume Overload; Cardiac Output, High; Fluid Overload; Cardiac Disease; Cardiac Output, Low; Fluid Loss
• Interventions: Diagnostic Test: pro-ANP

• Registration Number: NCT05070819
• Lead Sponsor: Petrovsky National Research Centre of Surgery

Brief Summary

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 Timeline

• Study Start: 2021-09-23
• Study First Submitted: 2021-09-27
• Study First Submitted QC: 2021-09-27
• Study First Posted: 2021-10-07
• Primary Completion: 2022-03-28
• Study Completion: 2022-04-07
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardiac surgery patients	pro-ANP	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

Primary Outcome Measures

Name	Time	Method
Number of patients with CI rise > 10% after PLR maneuver	intraoperatively	2 stages of Teboul test assessment
Number of patients with pro-ANP twofold raise by the end of surgery	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	intraoperative	According to positive PLR the assessment of pro-ANP consequent raise

Secondary Outcome Measures

Name	Time	Method
Heart failure	up to 10 days	Need in medicamental cardiotonic support more than 1 day
Infection rate	up to 10 days	Number of patients who develop systemic infection and/or operation wound infection
Mortality	up to 10 days	Mortality rate
Multiorgan failure	up to 10 days	Number of more than 2 organs failure
Respiratory failure	up to 10 days	Number of patients who require prolonged and/or repeated artificial lung ventilation
Renal failure	up to 10 days	Number of patients who require extracorporeal detoxication
Circulatory insufficiency	up to 10 days	Need in medicamental vasopressor support more than 1 day
Length of intensive care stay	up to 10 days	Duration of summarized length in ICU, including readmission to ICU
Postoperative complications	up to 10 days	Total amount of various postoperative complications

Trial Locations

Locations (1)

Petrovsky Research National Centre of Surgery (Petrovsky NRCS); 🇷🇺 Moscow, Russian Federation