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NCT Number: NCT04084301

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

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.

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Key information

Conditions

Extracorporeal Circulation; Complications Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Cardiopulmonary Bypass Central Nervous System Diseases Circulation Disorder Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gangliosidoses Gangliosidoses, GM2 Genetic Diseases, Inborn Hemolysis Inflammation Inflammatory Response Kidney Diseases Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Lipidoses Lysosomal Storage Diseases Lysosomal Storage Diseases, Nervous System Male Urogenital Diseases Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Failure Renal Insufficiency Renal Plasma Flow, Effective Sphingolipidoses Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lukas Lannemyr

Gothenburg, Västra Götaland County, 416 53, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High CPB flow

Procedure

Target CPB flow 2.9 L/min/m2 throughout the CPB period

Primary outcomes

  1. Biomarker u-NAG

    Time frame: 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.

  2. Biomarkers Nephrocheck

    Time frame: 24 hours

    Renal biomarker assay Nephrocheck (IGFBP-7 x TIMP-2) will be analyzed in urine

  3. Renal oxygen delivery and blood flow

    Time frame: 6 hours

    Renal oxygen delivery during and after cardiopulmonary bypass (CPB)

Secondary outcomes

  1. Serum creatinine and acute kidney injury (AKI)

    Time frame: 48 hours

    Changes in serum creatinine

  2. Inflammation IL-1

    Time frame: 24 hours

    Differences in inflammatory marker IL-1

  3. Inflammation IL-6

    Time frame: 24 hours

    Differences in inflammatory marker IL-6

  4. Inflammation IL-8

    Time frame: 24 hours

    Differences in inflammatory marker IL-8

  5. Inflammation IL-10

    Time frame: 24 hours

    Differences in inflammatory markers IL-1, IL-6, IL-8, IL-10 and TNFa

  6. Inflammation TNFa

    Time frame: 24 hours

    Differences in inflammatory marker TNFa

  7. Complement activation

    Time frame: 24 hours

    Differences in complement activation

  8. Hemolysis

    Time frame: 24 hours

    Differences in markers of hemolysis (free plasma Hb, LD, haptoglobin)

  9. Erythropoetin

    Time frame: 24 hours

    Differences in serum-erythropoietin

  10. Neuroinflammation Tau

    Time frame: 4 days

    Changes in Tau

  11. Neuroinflammation NF

    Time frame: 4 days

    Changes Neurofilament

  12. Kidney function

    Time frame: 24 hours

    Measured glomerular filtration rate (iohexol clearance) on postoperative day 1

  13. Renal function

    Time frame: 24 hours

    Measured glomerular filtration rate by iohexole clearance on the first postoperative day

Other outcomes

  1. Urinary pO2

    Time frame: 24 hours

    Changes in urinary pO2 measured with laser doppler technique. Correlation with global renal oxygenation will be explored.

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Acronym: ICAROX2

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Sep 10, 2019
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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