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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-25

Study Completion Date

2021-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Ultrasonography, Renal Cardiac Surgery Hemodynamics Phenylephrine Renal Perfusion Echocardiography Anesthesia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

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.

Study Groups

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All patients included

Group Type EXPERIMENTAL

Phenylephrine

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No