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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04419662
• Other study ID #: 1-10-72-40-20
• Secondary ID: 2020-000573-25
• Status: Completed
• Phase: Phase 4
• Start date: May 25, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: August 2021
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 31, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Department of Anaesthesiology	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal arterial resistive index (RI).		75 minutes
Primary	The ratio SVR/PVR (systemic vascular resistance/pulmonary vascular resistance)		75 minutes
Secondary	Renal venous impedance index.		75 minutes
Secondary	Renal venous stasis index.		75 minutes
Secondary	Portal vein pulsatility fraction.		75 minutes
Secondary	Cardiac output		75 minutes
Secondary	Arterial blood pressure, central venous pressure, pulmonary blood pressure, pulmonary capillary wedge pressure.		75 minutes
Secondary	Transoesophageal measurement of left and right ventricular function 1	Systolic measure (ejection fraction (EF))	75 minutes
Secondary	Transoesophageal measurement of left and right ventricular function 2	Systolic measure (s')	75 minutes
Secondary	Transoesophageal measurement of left and right ventricular function 3	Systolic measure (strain)	75 minutes
Secondary	Transoesophageal measurement of left and right ventricular function 4	Diastolic measures (E, A,)	75 minutes
Secondary	Transoesophageal measurement of left and right ventricular function 5	Diastolic measures (e', a')	75 minutes
Secondary	Transoesophageal measurement of left and right ventricular function 6	Diastolic measure (deceleration time)	75 minutes