Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury

Renal Failure Clinical Trial

— ICAROX2  

Official title:

Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04084301
• Other study ID #: ICAROX2
• Status: Completed
• Phase: N/A
• Start date: September 27, 2019
• Est. completion date: November 1, 2023

Study information

• Verified date: November 2023
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiopulmonary Bypass
• Circulation Disorder
• Extracorporeal Circulation; Complications
• Hemolysis
• Inflammatory Response
• Renal Failure
• Renal Plasma Flow, Effective

Intervention

Procedure:
• High CPB flow
Target CPB flow 2.9 L/min/m2 throughout the CPB period

Locations

Country	Name	City	State
Sweden	Lukas Lannemyr	Göteborg	Västra Götaland

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

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 O — View 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. — View 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: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Urinary pO2	Changes in urinary pO2 measured with laser doppler technique. Correlation with global renal oxygenation will be explored.	24 hours
Primary	Biomarker u-NAG	Tubulus injury biomarker N-acetyl-ß-d-glucoseaminidase (NAG) will be analyzed in urine with a spectrophotometric method and corrected for urine creatinine.	24 hours
Primary	Biomarkers Nephrocheck	Renal biomarker assay Nephrocheck (IGFBP-7 x TIMP-2) will be analyzed in urine	24 hours
Primary	Renal oxygen delivery and blood flow	Renal oxygen delivery during and after cardiopulmonary bypass (CPB)	6 hours
Secondary	Serum creatinine and acute kidney injury (AKI)	Changes in serum creatinine	48 hours
Secondary	Inflammation IL-1	Differences in inflammatory marker IL-1	24 hours
Secondary	Inflammation IL-6	Differences in inflammatory marker IL-6	24 hours
Secondary	Inflammation IL-8	Differences in inflammatory marker IL-8	24 hours
Secondary	Inflammation IL-10	Differences in inflammatory markers IL-1, IL-6, IL-8, IL-10 and TNFa	24 hours
Secondary	Inflammation TNFa	Differences in inflammatory marker TNFa	24 hours
Secondary	Complement activation	Differences in complement activation	24 hours
Secondary	Hemolysis	Differences in markers of hemolysis (free plasma Hb, LD, haptoglobin)	24 hours
Secondary	Erythropoetin	Differences in serum-erythropoietin	24 hours
Secondary	Neuroinflammation Tau	Changes in Tau	4 days
Secondary	Neuroinflammation NF	Changes Neurofilament	4 days
Secondary	Kidney function	Measured glomerular filtration rate (iohexol clearance) on postoperative day 1	24 hours
Secondary	Renal function	Measured glomerular filtration rate by iohexole clearance on the first postoperative day	24 hours