NCT04419662

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2020

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2020

Completed
25 days until next milestone

Study Start

First participant enrolled

May 25, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

August 6, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

April 30, 2020

Last Update Submit

August 5, 2021

Conditions

Ultrasonography, RenalCardiac SurgeryHemodynamicsPhenylephrineRenal PerfusionEchocardiographyAnesthesia

Outcome Measures

Primary Outcomes (2)

  • Renal arterial resistive index (RI).

    75 minutes

  • The ratio SVR/PVR (systemic vascular resistance/pulmonary vascular resistance)

    75 minutes

Secondary Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (1)

All patients included

EXPERIMENTAL
Drug: PhenylephrineOther: Combination of PEEP and positioning

Interventions

PhenylephrineDRUG

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.

All patients included
Combination of PEEP and positioningOTHER

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.

All patients included

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital, Department of Anaesthesiology

Aarhus, 8200, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 37186094DERIVED

  • 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.

    PMID: 35230558DERIVED

MeSH Terms

Interventions

PhenylephrinePatient Positioning

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Peter Juhl-Olsen, MD, PhD

    Aarhus University Hospital

    STUDY CHAIR

  • Johan F Hermansen, MD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Masking Details
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.
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 30, 2020

First Posted

June 5, 2020

Study Start

May 25, 2020

Primary Completion

May 30, 2021

Study Completion

May 31, 2021

Last Updated

August 6, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)