A Phase 4 interventional study of Phenylephrine and Combination of PEEP and positioning in Ultrasonography, Renal, Cardiac Surgery and Hemodynamics, sponsored by Aarhus University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-06.
Sponsored by Aarhus University Hospital · Phase 4, Interventional, and Diagnostic
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.
Aarhus University Hospital is the lead sponsor of 289 studies on the registry; 79 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Phenylephrine · Other: Combination of PEEP and positioning
Three time points: before, during and 20-30 minutes after infusion of phenylephrine. Patients will receive an infusion of up to 1 mcg/kg/min phenylephrine intravenously to raise mean arterial pressure with 20 mmHg for 10 minutes. Infusion of phenylephrine will start at 0.1 mcg/kg/min with subsequent titration to effect.
Six time points based on combinations of the following: Three different levels of PEEP (as set on the ventilator): 0, 6 and 12 mmHg. Two different positions: 1) torso elevated 30 degrees, legs horizontal and 2) torso horizontal, legs elevated 30 degrees.
Renal arterial resistive index (RI).
Time frame: 75 minutes
The ratio SVR/PVR (systemic vascular resistance/pulmonary vascular resistance)
Time frame: 75 minutes
Renal venous impedance index.
Time frame: 75 minutes
Renal venous stasis index.
Time frame: 75 minutes
Portal vein pulsatility fraction.
Time frame: 75 minutes
Cardiac output
Time frame: 75 minutes
Arterial blood pressure, central venous pressure, pulmonary blood pressure, pulmonary capillary wedge pressure.
Time frame: 75 minutes
Transoesophageal measurement of left and right ventricular function 1
Systolic measure (ejection fraction (EF))
Time frame: 75 minutes
Transoesophageal measurement of left and right ventricular function 2
Systolic measure (s')
Time frame: 75 minutes
Transoesophageal measurement of left and right ventricular function 3
Systolic measure (strain)
Time frame: 75 minutes
Transoesophageal measurement of left and right ventricular function 4
Diastolic measures (E, A,)
Time frame: 75 minutes
Transoesophageal measurement of left and right ventricular function 5
Diastolic measures (e', a')
Time frame: 75 minutes
Transoesophageal measurement of left and right ventricular function 6
Diastolic measure (deceleration time)
Time frame: 75 minutes
Plan to share: No
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Aarhus University Hospital