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

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ClinicalTrials.gov Identifier: NCT04084301
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Lukas Lannemyr, 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.

Condition or disease Intervention/treatment Phase
Extracorporeal Circulation; Complications Renal Failure Circulation Disorder Renal Plasma Flow, Effective Cardiopulmonary Bypass Hemolysis Inflammatory Response Procedure: High CPB flow Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: To compare normal (2.4 L/min/m2) and high (2.9 L/min/m2) cardiopulmonary bypass flow during cardiac surgery
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury
Estimated Study Start Date : September 9, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Arm Intervention/treatment
No Intervention: Normal CPB flow
In this group, the target flow during cardiopulmonary bypass (CPB) will be 2.4 L/min/m2 throughout the CPB period.
Experimental: High CPB flow
In this group, the target flow during cardiopulmonary bypass (CPB) will be 2.9 L/min/m2 throughout the CPB period.
Procedure: High CPB flow
Target CPB flow 2.9 L/min/m2 throughout the CPB period




Primary Outcome Measures :
  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 Outcome Measures :
  1. Serum creatinine and acute kidney injury (AKI) [ Time Frame: 48 hours ]
    Changes in serum creatinine

  2. Inflammation [ Time Frame: 24 hours ]
    Differences in inflammatory markers IL-1, IL-6, IL-8, IL-10 and TNFa

  3. Complement activation [ Time Frame: 24 hours ]
    Differences in complement activation

  4. Hemolysis [ Time Frame: 24 hours ]
    Differences in markers of hemolysis (free plasma Hb, LD, haptoglobin)

  5. Erythropoetin [ Time Frame: 24 hours ]
    Differences in serum-erythropoietin

  6. Neuroinflammation [ Time Frame: 4 days ]
    Changes in Tau and Neurofilament

  7. Kidney function [ Time Frame: 24 hours ]
    Measured glomerular filtration rate (iohexol clearance) on postoperative day 1


Other Outcome Measures:
  1. Urinary pO2 [ Time Frame: 24 hours ]
    Changes in urinary pO2 measured with laser doppler technique. Correlation with global renal oxygenation will be explored.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04084301


Contacts
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Contact: Lukas Lannemyr, MD +46313428860 lukas.lannemyr@vgregion.se
Contact: Sven-Erik Ricksten, MD, PhD +46313421000 ext 7433 sven-erik.ricksten@aniv.gu.se

Locations
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Sweden
Lukas Lannemyr Recruiting
Göteborg, Västra Götaland, Sweden, 416 53
Contact: Lukas Lannemyr, MD, PhD    +46313428860    lukas.lannemyr@vgregion.se   
Contact: Sven-Erik Ricksten, MD, PhD       sven-erik.ricksten@aniv.gu.se   
Sub-Investigator: Johanna Wijk, MD         
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden

Publications of Results:
Other Publications:
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Responsible Party: Lukas Lannemyr, Specialist of Anesthesia and Intensive care, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT04084301     History of Changes
Other Study ID Numbers: ICAROX2
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lukas Lannemyr, Sahlgrenska University Hospital, Sweden:
renal oxygenation
renal blood flow
cardiopulmonary bypass
tubular cell injury
N-acetyl-beta-D-glucosaminidase
nephrocheck
inflammation
hemolysis
Additional relevant MeSH terms:
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Hemolysis
Pathologic Processes