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OpenTrials
Completed

NCT Number: NCT04419662

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.

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Key information

Conditions

Ultrasonography, Renal Anesthesia Cardiac Surgery Echocardiography Hemodynamics Phenylephrine Renal Perfusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aarhus University Hospital, Department of Anaesthesiology

Aarhus, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Renal arterial resistive index (RI).

    Time frame: 75 minutes

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

    Time frame: 75 minutes

Secondary outcomes

  1. Renal venous impedance index.

    Time frame: 75 minutes

  2. Renal venous stasis index.

    Time frame: 75 minutes

  3. Portal vein pulsatility fraction.

    Time frame: 75 minutes

  4. Cardiac output

    Time frame: 75 minutes

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

    Time frame: 75 minutes

  6. Transoesophageal measurement of left and right ventricular function 1

    Time frame: 75 minutes

    Systolic measure (ejection fraction (EF))

  7. Transoesophageal measurement of left and right ventricular function 2

    Time frame: 75 minutes

    Systolic measure (s')

  8. Transoesophageal measurement of left and right ventricular function 3

    Time frame: 75 minutes

    Systolic measure (strain)

  9. Transoesophageal measurement of left and right ventricular function 4

    Time frame: 75 minutes

    Diastolic measures (E, A,)

  10. Transoesophageal measurement of left and right ventricular function 5

    Time frame: 75 minutes

    Diastolic measures (e', a')

  11. Transoesophageal measurement of left and right ventricular function 6

    Time frame: 75 minutes

    Diastolic measure (deceleration time)

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 5, 2020
Registry last updated
Aug 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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