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Clinical Trials/NCT04419662
NCT04419662
Completed
Phase 4

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

Aarhus University Hospital1 site in 1 country30 target enrollmentMay 25, 2020

Overview

Phase
Phase 4
Intervention
Phenylephrine
Conditions
Ultrasonography, Renal
Sponsor
Aarhus University Hospital
Enrollment
30
Locations
1
Primary Endpoint
Renal arterial resistive index (RI).
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 25, 2020
End Date
May 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Aarhus University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Johan Fridolf Hermansen

Principal Investigator

Aarhus University Hospital

Eligibility Criteria

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

Arms & Interventions

All patients included

Intervention: Phenylephrine

All patients included

Intervention: Combination of PEEP and positioning

Outcomes

Primary Outcomes

Renal arterial resistive index (RI).

Time Frame: 75 minutes

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

Time Frame: 75 minutes

Secondary Outcomes

  • Transoesophageal measurement of left and right ventricular function 5(75 minutes)
  • Renal venous impedance index.(75 minutes)
  • Transoesophageal measurement of left and right ventricular function 1(75 minutes)
  • Transoesophageal measurement of left and right ventricular function 6(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)
  • Transoesophageal measurement of left and right ventricular function 2(75 minutes)
  • Transoesophageal measurement of left and right ventricular function 3(75 minutes)
  • Transoesophageal measurement of left and right ventricular function 4(75 minutes)

Study Sites (1)

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