Clinical trial NCT04084301: Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury
Official title: Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extracorporeal Circulation; Complications
Renal Failure
Circulation Disorder
Renal Plasma Flow, Effective
Cardiopulmonary Bypass
Hemolysis
Inflammatory Response
Keywords: renal oxygenation
renal blood flow
cardiopulmonary bypass
tubular cell injury
N-acetyl-beta-D-glucosaminidase
nephrocheck
inflammation
hemolysis
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To compare normal (2.4 L/min/m2) and high (2.9 L/min/m2) cardiopulmonary bypass flow during cardiac surgery
Primary purpose: PREVENTION

Brief summary: During open cardiac surgery, cardiopulmonary bypass (CPB) is used to temporarily replace the function of the heart and lungs. Renal ischemia resulting in acute kidney injury is common after cardiac surgery. The renal oxygenation is impaired during CPB, but the oxygenation may be improved by increasing the CPB blood flow. In this randomized study, two CPB flow rates will be compared regarding renal outcome (biomarkers and renal oxygenation/renal blood flow), as well as markers of inflammation and hemolysis. Additionally, urine oxygen tension will be measured during CPB and the early intensive care phase and compared to renal oxygenation. Regional oxygen saturation assessed with near infrared spectroscopy from the brain and kidneys will be monitored during and after surgery.


Eligibility criteria: Inclusion Criteria:

* Written, signed informed consent
* Male and female subjects ≥18 years
* Left ventricular ejection fraction ≥30 %
* Estimated GFR ≥30 ml/min using the CKD-EPI equation (Levey 2009)
* Scheduled open cardiac surgery with CPB
* Planned normothermia during CPB
* Expected CPB time \> 60 minutes

Exclusion Criteria:

* Emergency surgery
* Cardiac transplantation
* Advanced grown-up congenital heart disease corrections
* Previous cerebral infarction, verified with computed tomography or magnetic resonance imaging
* Body mass index \> 32 kg/m2
* Use of hypothermia \< 32 °C during CPB
* Inability of the patient to give based opinion
* In the investigator´s opinion, the patient has a condition that could be adversely affected by study participation

Primary outcomes:
measure: Biomarker u-NAG
timeFrame: 24 hours
measure: Biomarkers Nephrocheck
timeFrame: 24 hours
measure: Renal oxygen delivery and blood flow
timeFrame: 6 hours
Secondary outcomes:
measure: Serum creatinine and acute kidney injury (AKI)
timeFrame: 48 hours
measure: Inflammation IL-1
timeFrame: 24 hours
measure: Inflammation IL-6
timeFrame: 24 hours
measure: Inflammation IL-8
timeFrame: 24 hours
measure: Inflammation IL-10
timeFrame: 24 hours
measure: Inflammation TNFa
timeFrame: 24 hours
measure: Complement activation
timeFrame: 24 hours
measure: Hemolysis
timeFrame: 24 hours
measure: Erythropoetin
timeFrame: 24 hours
measure: Neuroinflammation Tau
timeFrame: 4 days
measure: Neuroinflammation NF
timeFrame: 4 days
measure: Kidney function
timeFrame: 24 hours
measure: Renal function
timeFrame: 24 hours
Other outcomes:
measure: Urinary pO2
timeFrame: 24 hours
Locations:
city: Göteborg
country: Sweden
facility: Lukas Lannemyr
state: Västra Götaland
Study officials:
References:
citation: Lannemyr L, Bragadottir G, Krumbholz V, Redfors B, Sellgren J, Ricksten SE. Effects of Cardiopulmonary Bypass on Renal Perfusion, Filtration, and Oxygenation in Patients Undergoing Cardiac Surgery. Anesthesiology. 2017 Feb;126(2):205-213. doi: 10.1097/ALN.0000000000001461.
citation: Lannemyr L, Bragadottir G, Hjarpe A, Redfors B, Ricksten SE. Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation in Patients Undergoing Cardiac Operations. Ann Thorac Surg. 2019 Feb;107(2):505-511. doi: 10.1016/j.athoracsur.2018.08.085. Epub 2018 Oct 23.
citation: Lannemyr L, Lundin E, Reinsfelt B, Bragadottir G, Redfors B, Oras J, Ricksten SE. Renal tubular injury during cardiopulmonary bypass as assessed by urinary release of N-acetyl-ss-D-glucosaminidase. Acta Anaesthesiol Scand. 2017 Oct;61(9):1075-1083. doi: 10.1111/aas.12946. Epub 2017 Jul 26.