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

November 20, 2023 updated by: Lukas Lannemyr, Sahlgrenska University Hospital, Sweden
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
    • Västra Götaland
      • Göteborg, Västra Götaland, Sweden, 416 53
        • Lukas Lannemyr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours
Biomarkers Nephrocheck
Time Frame: 24 hours
Renal biomarker assay Nephrocheck (IGFBP-7 x TIMP-2) will be analyzed in urine
24 hours
Renal oxygen delivery and blood flow
Time Frame: 6 hours
Renal oxygen delivery during and after cardiopulmonary bypass (CPB)
6 hours

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary pO2
Time Frame: 24 hours
Changes in urinary pO2 measured with laser doppler technique. Correlation with global renal oxygenation will be explored.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2019

Primary Completion (Actual)

November 1, 2023

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

February 4, 2019

First Submitted That Met QC Criteria

September 6, 2019

First Posted (Actual)

September 10, 2019

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICAROX2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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