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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04084301
Other study ID # ICAROX2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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