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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06440772
Other study ID # 9593/04.04.2024
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2023
Est. completion date July 1, 2024

Study information

Verified date June 2024
Source Institutul de Urgenta pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
Contact Cosmin Balan, PhD
Phone +40722751501
Email cosmin13mara@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study uses the portal vein pulsatility index (PVPI) to assess fluid intolerance amongst fluid responders.


Description:

This prospective observational study aims to use the portal vein pulsatility index (PVPI) to assess fluid intolerance in fluid responders. The investigators will enroll mechanically ventilated postoperative adult patients within 6 hours of ICU admission after cardiac surgery. Patients will undergo a Passive Leg Raising (PLR) test and Left Ventricular Outflow Tract (LVOT) recording using transthoracic echocardiography. The main objective is to predict fluid intolerance after a fluid challenge of 7 ml/kg Ringer Lactate over 10 minutes in initially tolerant fluid responders.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date July 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Informed consent. - Mechanically ventilated patients within 6 hours after ICU admission following surgery who are considered for fluid administration to optimize haemodynamics. - Sinus rhythm. Exclusion Criteria: - A condition known to interfere with portal vein flow assessment or interpretation (liver cirrhosis or chronic hepatic disease, suprahepatic or portal vein thrombosis). - Any mechanical circulatory support. - Cardiac transplant. - Poor transthoracic echocardiographic window.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ringer's Lactate Crystalloid Solutions
7 ml/kg ml of Ringer's Lactate is given in 10 min amongst initially tolerant fluid responders.

Locations

Country Name City State
Romania "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases Bucharest

Sponsors (1)

Lead Sponsor Collaborator
Institutul de Urgenta pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu

Country where clinical trial is conducted

Romania, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fluid Intolerance A portal vein pulsatility index greater than 50%, calculated as (Vmax - Vmin) / Vmax, with no upper limit and 0% as the minimum limit. Higher values indicate worse outcomes. Ultrasonographic portal spectral waveform was used to measure Vmax and Vmin. 10 minutes after 7 ml/kg Ringer's Lactate
See also
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Recruiting NCT06251713 - Fluid-removal Guided by VeXUS Score With Usual Care in Patients With Acute Kidney Injury After Cardiac Surgery N/A
Recruiting NCT04914455 - Transhepatic Echography for Fluid Responsiveness After Cardiovascular Surgery
Not yet recruiting NCT06160856 - Correlation of Ultrasonography Indices of Venous Congestion With Intra-abdominal Pressure in ICU Patients.