Clinical Trials Logo
  1. Home
  2. Anesthesia
  3. NCT04419662
  4. Details
NCT04419662 Clinical Trial

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
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04279054 - Decreased Neuraxial Morphine After Cesarean Delivery Early Phase 1
Active, not recruiting NCT04580030 - Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Recruiting NCT04099693 - A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
Terminated NCT02481999 - Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
Completed NCT04235894 - An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
Recruiting NCT05525104 - The Effect of DSA on Recovery of Anaesthesia in Children (Het Effect Van DSA op Het Herstel na Anesthesie Bij Kinderen). N/A
Recruiting NCT05024084 - Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth Phase 4
Completed NCT04204785 - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions N/A
Completed NCT03277872 - NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope N/A
Terminated NCT03940651 - Cardiac and Renal Biomarkers in Arthroplasty Surgery Phase 4
Terminated NCT02529696 - Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Terminated NCT03704285 - Development of pk/pd Model of Propofol in Patients With Severe Burns
Recruiting NCT05259787 - EP Intravenous Anesthesia in Hysteroscopy Phase 4
Completed NCT02894996 - Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient? N/A
Completed NCT05386082 - Anesthesia Core Quality Metrics Consensus Delphi Study
Terminated NCT03567928 - Laryngeal Mask in Upper Gastrointestinal Procedures N/A
Recruiting NCT06074471 - Motor Sparing Supraclavicular Block N/A
Completed NCT04163848 - CARbon Impact of aNesthesic Gas