Clinical trial NCT04419662: Evaluation of Patients After Cardiac Surgery: Novel Ultrasound Parameters for Quantification of Renal Perfusion & Analysis of Phenylephrines' Effect on Invasive Haemodynamics and Echocardiographic Measures
Official title: Evaluation of Patients After Cardiac Surgery: Novel Ultrasound Parameters for Quantification of Renal Perfusion & Analysis of Phenylephrines' Effect on Invasive Haemodynamics and Echocardiographic Measures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ultrasonography, Renal
Cardiac Surgery
Hemodynamics
Phenylephrine
Renal Perfusion
Echocardiography
Anesthesia
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To investigate the influence of PEEP (Positive end-expiratory pressure), changes in preload (patient position) and changes in afterload (phenylephrine) on ultrasound measures of renal perfusion in patients after uncomplicated cardiac surgery.

To investigate the effects of phenylephrine on both invasive measures of the systemic- and pulmonary circulation and, secondarily, to assess the induced changes in echocardiographic indices of left- and right ventricular systolic- and diastolic function.


Eligibility criteria: Inclusion Criteria:

* All patients ≥ 18 years scheduled for open elective cardiac surgery at the Department of Cardiothoracic \& Vascular Surgery, Aarhus University Hospital.

Exclusion Criteria:

* Insufficient ultrasonographic imaging of the kidneys
* Known morphological kidney disease
* Preoperative dialysis
* Chronic atrial fibrillation
* Planned mitral valve surgery

Primary outcomes:
measure: Renal arterial resistive index (RI).
timeFrame: 75 minutes
measure: The ratio SVR/PVR (systemic vascular resistance/pulmonary vascular resistance)
timeFrame: 75 minutes
Secondary outcomes:
measure: Renal venous impedance index.
timeFrame: 75 minutes
measure: Renal venous stasis index.
timeFrame: 75 minutes
measure: Portal vein pulsatility fraction.
timeFrame: 75 minutes
measure: Cardiac output
timeFrame: 75 minutes
measure: Arterial blood pressure, central venous pressure, pulmonary blood pressure, pulmonary capillary wedge pressure.
timeFrame: 75 minutes
measure: Transoesophageal measurement of left and right ventricular function 1
timeFrame: 75 minutes
measure: Transoesophageal measurement of left and right ventricular function 2
timeFrame: 75 minutes
measure: Transoesophageal measurement of left and right ventricular function 3
timeFrame: 75 minutes
measure: Transoesophageal measurement of left and right ventricular function 4
timeFrame: 75 minutes
measure: Transoesophageal measurement of left and right ventricular function 5
timeFrame: 75 minutes
measure: Transoesophageal measurement of left and right ventricular function 6
timeFrame: 75 minutes
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Department of Anaesthesiology
Study officials:
affiliation: Aarhus University Hospital
name: Peter Juhl-Olsen, MD, PhD
role: STUDY_CHAIR
affiliation: Aarhus University Hospital
name: Johan F Hermansen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hermansen JL, Norskov J, Juhl-Olsen P. Effects of changes in position, positive end-expiratory pressure and mean arterial pressure on renal, portal and hepatic Doppler ultrasound perfusion indices: a randomized crossover study in cardiac surgery patients. J Clin Monit Comput. 2022 Dec;36(6):1841-1850. doi: 10.1007/s10877-022-00834-0. Epub 2022 Mar 1.