Atrial Natriuretic Peptide in Assessing Fluid Status

Sponsor

Petrovsky National Research Centre of Surgery (Other)

Overall Status

Recruiting

CT.gov ID

NCT05070819

Collaborator

(none)

Enrollment

Location

Arm

6.2

Anticipated Duration (Months)

9.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Fluid Overload Fluid Loss Volume Overload Cardiac Disease Cardiac Output, Low Cardiac Output, High	Diagnostic Test: pro-ANP	N/A

Detailed Description

Routinely intraoperatively the fluid status assessment is based on central venous pressure and other pressometric parameters. Nevertheless, the minority of anesthesiologists use continious 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

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Sep 23, 2021

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Apr 1, 2022

Arms and Interventions

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 transtion 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.

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 transtion 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.

Outcome Measures

Primary Outcome Measures

Hypervolemia episodes [intraoperatively]
Based on hemodynamic, clinical and laboratory monitoring consistent intraoperative assessment of hypervolemia
Hypovolemia episodes [intraoperatively]
Based on hemodynamic, clinical and laboratory monitoring consistent intraoperative assessment of hypovolemia

Secondary Outcome Measures

Postoperative complications [up to 10 days]
Total amount of various postoperative complications
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
Heart failure [up to 10 days]
Need in medicamental cardiotonic support more than 1 day
Circulatory insufficiency [up to 10 days]
Need in medicamental vasopressor support more than 1 day
Infection rate [up to 10 days]
Number of patients who develop systemic infection and/or operation wound infection
Length of intensive care stay [up to 10 days]
Duration of summarized length in ICU, including readmission to ICU

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

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