ew ultrasound parameters reflecting kidney function & the effects of phenylphrine after cardiac surgery
Phase 1
- Conditions
- HypotensionTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2020-000573-25-DK
- Lead Sponsor
- Aarhus University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Elective cardiac anaesthesia
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the haemodynamic effects of phenylephrine;Secondary Objective: Not applicable;Primary end point(s): The effects of phenylephrine on the ratio SVR/PVR.<br><br><br>;Timepoint(s) of evaluation of this end point: Before, during af after infusion of phenylephrine (to a target MAP > 20mmHg of baseline)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The effects of phenylephrine on:<br>-Transoesophageal measurement of left ventricular function (strain, S-max, EF, E/e’) and right ventricular function (TAPSE, S-max, free wall strain, fractional shortening)<br>-Invasive measurements of the systemic and pulmonary circulation (central venous saturation, systolic/diastolic/mean pulmonary- and systemic blood pressure)<br>-Cardiac output, mixed venous saturation.;Timepoint(s) of evaluation of this end point: Before, during af after infusion of phenylephrine (to a target MAP > 20mmHg of baseline)