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

Not Applicable

Completed

• Conditions: Inflammatory Response; Renal Plasma Flow, Effective; Extracorporeal Circulation; Complications; Renal Failure; Circulation Disorder; Cardiopulmonary Bypass; Hemolysis
• Interventions: Procedure: High CPB flow

• Registration Number: NCT04084301
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-04
• Study First Submitted QC: 2019-09-06
• Study First Posted: 2019-09-10
• Study Start: 2019-09-27
• Status Verified: 2023-11
• Primary Completion: 2023-11-01
• Study Completion: 2023-11-01
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High CPB flow	High CPB flow	In this group, the target flow during cardiopulmonary bypass (CPB) will be 2.9 L/min/m2 throughout the CPB period.

Primary Outcome Measures

Name	Time	Method
Biomarkers Nephrocheck	24 hours	Renal biomarker assay Nephrocheck (IGFBP-7 x TIMP-2) will be analyzed in urine
Renal oxygen delivery and blood flow	6 hours	Renal oxygen delivery during and after cardiopulmonary bypass (CPB)
Biomarker u-NAG	24 hours	Tubulus injury biomarker N-acetyl-ß-d-glucoseaminidase (NAG) will be analyzed in urine with a spectrophotometric method and corrected for urine creatinine.

Secondary Outcome Measures

Name	Time	Method
Serum creatinine and acute kidney injury (AKI)	48 hours	Changes in serum creatinine
Inflammation IL-8	24 hours	Differences in inflammatory marker IL-8
Inflammation TNFa	24 hours	Differences in inflammatory marker TNFa
Inflammation IL-10	24 hours	Differences in inflammatory markers IL-1, IL-6, IL-8, IL-10 and TNFa
Inflammation IL-1	24 hours	Differences in inflammatory marker IL-1
Inflammation IL-6	24 hours	Differences in inflammatory marker IL-6
Hemolysis	24 hours	Differences in markers of hemolysis (free plasma Hb, LD, haptoglobin)
Erythropoetin	24 hours	Differences in serum-erythropoietin
Neuroinflammation NF	4 days	Changes Neurofilament
Complement activation	24 hours	Differences in complement activation
Kidney function	24 hours	Measured glomerular filtration rate (iohexol clearance) on postoperative day 1
Neuroinflammation Tau	4 days	Changes in Tau
Renal function	24 hours	Measured glomerular filtration rate by iohexole clearance on the first postoperative day

Trial Locations

Locations (1)

Lukas Lannemyr; 🇸🇪 Göteborg, Västra Götaland, Sweden