Evaluation of Patients After Cardiac Surgery: Novel Ultrasound Parameters for Quantification of Renal Perfusion & Analysis of Phenylephrines' Effect on Invasive Haemodynamics and Echocardiographic Measures

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery; Anesthesia; Hemodynamics; Echocardiography; Phenylephrine; Ultrasonography, Renal; Renal Perfusion
• Intervention / Treatment: Drug: Phenylephrine; Other: Combination of PEEP and positioning

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital, Department of Anaesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: All patients included

Drug: Phenylephrine; 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.; Other: Combination of PEEP and positioning; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Renal arterial resistive index (RI).	75 minutes
The ratio SVR/PVR (systemic vascular resistance/pulmonary vascular resistance)	75 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal venous impedance index.		75 minutes
Renal venous stasis index.		75 minutes
Portal vein pulsatility fraction.		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

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Investigators: Study Chair: Peter Juhl-Olsen, MD, PhD, Aarhus University Hospital; Principal Investigator: Johan F Hermansen, MD, Aarhus University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2020
• Primary Completion (Actual): May 30, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: April 30, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 6, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Respiratory System Agents; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Nasal Decongestants; Adrenergic alpha-1 Receptor Agonists; Phenylephrine; Oxymetazoline
• Other Study ID Numbers: 1-10-72-40-20; 2020-000573-25 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No