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Ultrasonography, RenalPhase 4NCT04419662

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

A Phase 4 study testing Phenylephrine and Combination of PEEP and positioning in people with Ultrasonography, Renal and Cardiac Surgery, run by Aarhus University Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Phenylephrine and Combination of PEEP and positioning
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteDenmark
Study dates
25 May 2020to 31 May 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Aarhus University Hospital, Department of Anaesthesiology

    Aarhus, 8200

Other trials in Denmark

About this study

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.

Being tested
Phenylephrine, Combination of PEEP and positioning

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT04419662
Study groupRoleWhat they receive
All patients includedExperimentalNot described
Receives: Drug: Phenylephrine; Other: Combination of PEEP and positioning

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Renal arterial resistive index (RI).

    Measured: 75 minutes

  2. The ratio SVR/PVR (systemic vascular resistance/pulmonary vascular resistance)

    Measured: 75 minutes

Secondary outcomes (11)

  1. Renal venous impedance index.

    Measured: 75 minutes

  2. Renal venous stasis index.

    Measured: 75 minutes

  3. Portal vein pulsatility fraction.

    Measured: 75 minutes

  4. Cardiac output

    Measured: 75 minutes

  5. Arterial blood pressure, central venous pressure, pulmonary blood pressure, pulmonary capillary wedge pressure.

    Measured: 75 minutes

  6. Transoesophageal measurement of left and right ventricular function 1

    Systolic measure (ejection fraction (EF))

    Measured: 75 minutes

  7. Transoesophageal measurement of left and right ventricular function 2

    Systolic measure (s')

    Measured: 75 minutes

  8. Transoesophageal measurement of left and right ventricular function 3

    Systolic measure (strain)

    Measured: 75 minutes

  9. Transoesophageal measurement of left and right ventricular function 4

    Diastolic measures (E, A,)

    Measured: 75 minutes

  10. Transoesophageal measurement of left and right ventricular function 5

    Diastolic measures (e', a')

    Measured: 75 minutes

  11. Transoesophageal measurement of left and right ventricular function 6

    Diastolic measure (deceleration time)

    Measured: 75 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2020
  2. Study start25 May 2020
  3. Primary completion30 May 2021
  4. Study completion31 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04419662
Sponsor's protocol ID
1-10-72-40-20
Other IDs
2020-000573-25
Status last verified
Aug 2021
First submitted
30 Apr 2020
Last updated
6 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37186094

  • 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.

    PubMed 35230558

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Phenylephrine and Combination of PEEP and positioning in people with Ultrasonography, Renal and Cardiac Surgery, run by Aarhus University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Renal arterial resistive index (RI). (time frame: 75 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04419662, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.

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