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

Phase 4

Completed

• Conditions: Phenylephrine; Ultrasonography, Renal; Hemodynamics; Cardiac Surgery; Echocardiography; Renal Perfusion; Anesthesia
• Interventions: Drug: Phenylephrine; Other: Combination of PEEP and positioning

• Registration Number: NCT04419662
• Lead Sponsor: Aarhus University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-30
• Study Start: 2020-05-25
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-05
• Primary Completion: 2021-05-30
• Study Completion: 2021-05-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-05
• Last Update Posted: 2021-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients included	Combination of PEEP and positioning	-
All patients included	Phenylephrine	-

Primary Outcome Measures

Name	Time	Method
Renal arterial resistive index (RI).	75 minutes
The ratio SVR/PVR (systemic vascular resistance/pulmonary vascular resistance)	75 minutes

Secondary Outcome Measures

Name	Time	Method
Transoesophageal measurement of left and right ventricular function 5	75 minutes	Diastolic measures (e', a')
Renal venous impedance index.	75 minutes
Transoesophageal measurement of left and right ventricular function 1	75 minutes	Systolic measure (ejection fraction (EF))
Renal venous stasis index.	75 minutes
Transoesophageal measurement of left and right ventricular function 6	75 minutes	Diastolic measure (deceleration time)
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	Systolic measure (s')
Transoesophageal measurement of left and right ventricular function 3	75 minutes	Systolic measure (strain)
Transoesophageal measurement of left and right ventricular function 4	75 minutes	Diastolic measures (E, A,)

Trial Locations

Locations (1)

Aarhus University Hospital, Department of Anaesthesiology; 🇩🇰 Aarhus, Denmark