Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury (ICAROX2)

Sahlgrenska University Hospital

Status: Completed

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

Treatments: Procedure: High CPB flow

Study type: Interventional

Funder types: Other

Identifiers

NCT04084301

ICAROX2

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Normal CPB flow

No Intervention group

Description:

In this group, the target flow during cardiopulmonary bypass (CPB) will be 2.4 L/min/m2 throughout the CPB period.

High CPB flow

Experimental group

Description:

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

Treatment:

Procedure: High CPB flow