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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000573-25 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients included | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenylephrine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Renal arterial resistive index (RI). | 75 minutes | |
| The ratio SVR/PVR (systemic vascular resistance/pulmonary vascular resistance) | 75 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Renal venous impedance index. | 75 minutes | |
| Renal venous stasis index. | 75 minutes | |
| Portal vein pulsatility fraction. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Juhl-Olsen, MD, PhD | Aarhus University Hospital | Study Chair |
| Johan F Hermansen, MD | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital, Department of Anaesthesiology | Aarhus | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37186094 | Derived | Juhl-Olsen P, Berg-Hansen K, Norskov J, Enevoldsen J, Hermansen JL. The haemodynamic effects of phenylephrine after cardiac surgery. Acta Anaesthesiol Scand. 2023 Aug;67(7):869-876. doi: 10.1111/aas.14256. Epub 2023 Apr 25. | |
| 35230558 | Derived | 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. |
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Ultrasound analysis is performed offline and details on participants and time of measurement are blinded for the person doing the analysis. The personnel responsible for obtaining data will not be blinded towards any of the interventions.
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|
| Combination of PEEP and positioning | Other | 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. |
|
| 75 minutes |
| Cardiac output | 75 minutes |
| Arterial blood pressure, central venous pressure, pulmonary blood pressure, pulmonary capillary wedge pressure. | 75 minutes |
| Transoesophageal measurement of left and right ventricular function 1 | Systolic measure (ejection fraction (EF)) | 75 minutes |
| Transoesophageal measurement of left and right ventricular function 2 | Systolic measure (s') | 75 minutes |
| Transoesophageal measurement of left and right ventricular function 3 | Systolic measure (strain) | 75 minutes |
| Transoesophageal measurement of left and right ventricular function 4 | Diastolic measures (E, A,) | 75 minutes |
| Transoesophageal measurement of left and right ventricular function 5 | Diastolic measures (e', a') | 75 minutes |
| Transoesophageal measurement of left and right ventricular function 6 | Diastolic measure (deceleration time) | 75 minutes |
| ID | Term |
|---|---|
| D010656 | Phenylephrine |
| D056888 | Patient Positioning |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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