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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04419662
Enrollment
30
Registered
2020-06-05
Start date
2020-05-25
Completion date
2021-05-31
Last updated
2021-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Cardiac Surgery, Echocardiography, Hemodynamics, Phenylephrine, Renal Perfusion, Ultrasonography, Renal

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.

Interventions

DRUGPhenylephrine

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.

OTHERCombination 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.

Sponsors

Aarhus University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Renal arterial resistive index (RI).75 minutes
The ratio SVR/PVR (systemic vascular resistance/pulmonary vascular resistance)75 minutes

Secondary

MeasureTime frameDescription
Portal vein pulsatility fraction.75 minutes
Cardiac output75 minutes
Arterial blood pressure, central venous pressure, pulmonary blood pressure, pulmonary capillary wedge pressure.75 minutes
Transoesophageal measurement of left and right ventricular function 175 minutesSystolic measure (ejection fraction (EF))
Renal venous impedance index.75 minutes
Transoesophageal measurement of left and right ventricular function 375 minutesSystolic measure (strain)
Transoesophageal measurement of left and right ventricular function 475 minutesDiastolic measures (E, A,)
Transoesophageal measurement of left and right ventricular function 575 minutesDiastolic measures (e', a')
Transoesophageal measurement of left and right ventricular function 675 minutesDiastolic measure (deceleration time)
Transoesophageal measurement of left and right ventricular function 275 minutesSystolic measure (s')
Renal venous stasis index.75 minutes

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026