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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05070819
Other study ID # 0394227092021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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