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Atrial Natriuretic Peptide in Assessing Fluid Status

Primary Purpose

Fluid Overload, Fluid Loss, Volume Overload

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
pro-ANP
Sponsored by
Petrovsky National Research Centre of Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Fluid Overload focused on measuring fluid responsiveness, fluid status, cardiac surgery, volemic status, pro-ANP, hemodynamic monitoring, functional test, teboul test, stroke volume variation, cardiac output

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Petrovsky Research National Centre of Surgery (Petrovsky NRCS)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cardiac surgery patients

Arm Description

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 transition from CPB circuit to patient Before Teboul' test at the end of surgery End of Teboul' test when lower limbs are lifted

Outcomes

Primary Outcome Measures

Number of patients with CI rise > 10% after PLR maneuver
2 stages of Teboul test assessment
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
Number of patients with pro-ANP increase > 10% by the PLR maneuver
According to positive PLR the assessment of pro-ANP consequent raise

Secondary Outcome Measures

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

Full Information

First Posted
September 27, 2021
Last Updated
September 27, 2022
Sponsor
Petrovsky National Research Centre of Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT05070819
Brief Title
Atrial Natriuretic Peptide in Assessing Fluid Status
Official Title
Role of Atrial Natriuretic Peptide in Assessing of Fluid Status in Cardiac Surgery Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 23, 2021 (Actual)
Primary Completion Date
March 28, 2022 (Actual)
Study Completion Date
April 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Petrovsky National Research Centre of Surgery

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cardiac surgery patients
Arm Type
Experimental
Arm Description
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 transition from CPB circuit to patient Before Teboul' test at the end of surgery End of Teboul' test when lower limbs are lifted
Intervention Type
Diagnostic Test
Intervention Name(s)
pro-ANP
Intervention Description
pro-ANP samples and fluid status assessment with functional tests (Teboul test) will be used 8 times intraoperatively.
Primary Outcome Measure Information:
Title
Number of patients with CI rise > 10% after PLR maneuver
Description
2 stages of Teboul test assessment
Time Frame
intraoperatively
Title
Number of patients with pro-ANP twofold raise by the end of surgery
Description
To assess the atria strain and consequent rise of pro-ANP by the end of surgery
Time Frame
intraoperatively
Title
Number of patients with pro-ANP increase > 10% by the PLR maneuver
Description
According to positive PLR the assessment of pro-ANP consequent raise
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
Postoperative complications
Description
Total amount of various postoperative complications
Time Frame
up to 10 days
Title
Mortality
Description
Mortality rate
Time Frame
up to 10 days
Title
Multiorgan failure
Description
Number of more than 2 organs failure
Time Frame
up to 10 days
Title
Respiratory failure
Description
Number of patients who require prolonged and/or repeated artificial lung ventilation
Time Frame
up to 10 days
Title
Renal failure
Description
Number of patients who require extracorporeal detoxication
Time Frame
up to 10 days
Title
Heart failure
Description
Need in medicamental cardiotonic support more than 1 day
Time Frame
up to 10 days
Title
Circulatory insufficiency
Description
Need in medicamental vasopressor support more than 1 day
Time Frame
up to 10 days
Title
Infection rate
Description
Number of patients who develop systemic infection and/or operation wound infection
Time Frame
up to 10 days
Title
Length of intensive care stay
Description
Duration of summarized length in ICU, including readmission to ICU
Time Frame
up to 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris Akselrod, Ph.D
Organizational Affiliation
Petrovsky RNCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Petrovsky Research National Centre of Surgery (Petrovsky NRCS)
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

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Atrial Natriuretic Peptide in Assessing Fluid Status

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