Atrial Natriuretic Peptide in Assessing Fluid Status

Cardiac Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05070819
• Other study ID #: 0394227092021
• Status: Completed
• Phase: N/A
• Start date: September 23, 2021
• Est. completion date: April 7, 2022

Study information

• Verified date: September 2022
• Source: Petrovsky National Research Centre of Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 7, 2022
• Est. primary completion date: March 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Disease
• Cardiac Output, High
• Cardiac Output, Low
• Fluid Loss
• Fluid Overload
• Heart Diseases
• Volume Overload

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Petrovsky Research National Centre of Surgery (Petrovsky NRCS)	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Petrovsky National Research Centre of Surgery

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with CI rise > 10% after PLR maneuver	2 stages of Teboul test assessment	intraoperatively
Primary	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
Primary	Number of patients with pro-ANP increase > 10% by the PLR maneuver	According to positive PLR the assessment of pro-ANP consequent raise	intraoperative
Secondary	Postoperative complications	Total amount of various postoperative complications	up to 10 days
Secondary	Mortality	Mortality rate	up to 10 days
Secondary	Multiorgan failure	Number of more than 2 organs failure	up to 10 days
Secondary	Respiratory failure	Number of patients who require prolonged and/or repeated artificial lung ventilation	up to 10 days
Secondary	Renal failure	Number of patients who require extracorporeal detoxication	up to 10 days
Secondary	Heart failure	Need in medicamental cardiotonic support more than 1 day	up to 10 days
Secondary	Circulatory insufficiency	Need in medicamental vasopressor support more than 1 day	up to 10 days
Secondary	Infection rate	Number of patients who develop systemic infection and/or operation wound infection	up to 10 days
Secondary	Length of intensive care stay	Duration of summarized length in ICU, including readmission to ICU	up to 10 days