Extracorporeal Circulation; ComplicationsICAROX2NCT04084301
Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury
A study testing High CPB flow in people with Extracorporeal Circulation; Complications and Renal Failure, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Circulation; Complications, Renal Failure, Circulation Disorder
- What is being tested?
- High CPB flow
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 27 Sep 2019to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Extracorporeal Circulation; Complications, Renal Failure, Circulation Disorder, Renal Plasma Flow, Effective, Cardiopulmonary Bypass, Hemolysis
- Being tested
- High CPB flow
- Keywords
- renal oxygenation, renal blood flow, cardiopulmonary bypass, tubular cell injury, N-acetyl-beta-D-glucosaminidase, nephrocheck, inflammation, hemolysis
- Medical subject headings
- Renal Insufficiency, Hemolysis, Gangliosidoses, GM2, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High CPB flowProcedure or surgery
Target CPB flow 2.9 L/min/m2 throughout the CPB period
| Study group | Role | What they receive |
|---|---|---|
| Normal CPB flow | No intervention | 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 | In this group, the target flow during cardiopulmonary bypass (CPB) will be 2.9 L/min/m2 throughout the CPB period. Receives: Procedure: High CPB flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker u-NAG
Tubulus injury biomarker N-acetyl-ß-d-glucoseaminidase (NAG) will be analyzed in urine with a spectrophotometric method and corrected for urine creatinine.
Measured: 24 hours
Biomarkers Nephrocheck
Renal biomarker assay Nephrocheck (IGFBP-7 x TIMP-2) will be analyzed in urine
Measured: 24 hours
Renal oxygen delivery and blood flow
Renal oxygen delivery during and after cardiopulmonary bypass (CPB)
Measured: 6 hours
Secondary outcomes (13)
Serum creatinine and acute kidney injury (AKI)
Changes in serum creatinine
Measured: 48 hours
Inflammation IL-1
Differences in inflammatory marker IL-1
Measured: 24 hours
Inflammation IL-6
Differences in inflammatory marker IL-6
Measured: 24 hours
Inflammation IL-8
Differences in inflammatory marker IL-8
Measured: 24 hours
Inflammation IL-10
Differences in inflammatory markers IL-1, IL-6, IL-8, IL-10 and TNFa
Measured: 24 hours
Inflammation TNFa
Differences in inflammatory marker TNFa
Measured: 24 hours
Complement activation
Differences in complement activation
Measured: 24 hours
Hemolysis
Differences in markers of hemolysis (free plasma Hb, LD, haptoglobin)
Measured: 24 hours
Erythropoetin
Differences in serum-erythropoietin
Measured: 24 hours
Neuroinflammation Tau
Changes in Tau
Measured: 4 days
Neuroinflammation NF
Changes Neurofilament
Measured: 4 days
Kidney function
Measured glomerular filtration rate (iohexol clearance) on postoperative day 1
Measured: 24 hours
Renal function
Measured glomerular filtration rate by iohexole clearance on the first postoperative day
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start27 Sep 2019
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Extracorporeal Circulation; ComplicationsStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lukas Lannemyr, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084301
- Sponsor's protocol ID
- ICAROX2
- Acronym
- ICAROX2
- Status last verified
- Nov 2023
- First submitted
- 4 Feb 2019
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lannemyr L, Bragadottir G, Krumbholz V, Redfors B, Sellgren J, Ricksten SE. Effects of Cardiopulmonary Bypass on Renal Perfusion, Filtration, and Oxygenation in Patients Undergoing Cardiac Surgery. Anesthesiology. 2017 Feb;126(2):205-213. doi: 10.1097/ALN.0000000000001461.
PubMed 27906706Lannemyr L, Bragadottir G, Hjarpe A, Redfors B, Ricksten SE. Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation in Patients Undergoing Cardiac Operations. Ann Thorac Surg. 2019 Feb;107(2):505-511. doi: 10.1016/j.athoracsur.2018.08.085. Epub 2018 Oct 23.
PubMed 30365961Lannemyr L, Lundin E, Reinsfelt B, Bragadottir G, Redfors B, Oras J, Ricksten SE. Renal tubular injury during cardiopulmonary bypass as assessed by urinary release of N-acetyl-ss-D-glucosaminidase. Acta Anaesthesiol Scand. 2017 Oct;61(9):1075-1083. doi: 10.1111/aas.12946. Epub 2017 Jul 26.
PubMed 28748536Wijk J, Corderfeldt-Keiller A, Bragadottir G, Redfors B, Ricksten SE, Lannemyr L. Cardiopulmonary Bypass Flow Rate and the Kidney: Reply. Anesthesiology. 2026 May 1;144(5):1259-1260. doi: 10.1097/ALN.0000000000005957. Epub 2026 Mar 16. No abstract available.
PubMed 41838934
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury
- ClinicalTrials.gov ID
- NCT04084301
- Acronym / sponsor ID
- ICAROX2 / ICAROX2
- Conditions
- Extracorporeal Circulation; Complications, Renal Failure, Circulation Disorder, Renal Plasma Flow, Effective, Cardiopulmonary Bypass, Hemolysis
- Keywords
- renal oxygenation, renal blood flow, cardiopulmonary bypass, tubular cell injury, N-acetyl-beta-D-glucosaminidase, nephrocheck, inflammation, hemolysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To compare normal (2.4 L/min/m2) and high (2.9 L/min/m2) cardiopulmonary bypass flow during cardiac surgery
| Arm | Type | Receives |
|---|---|---|
| Normal CPB flow | No intervention | –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 | Procedure: High CPB flowIn this group, the target flow during cardiopulmonary bypass (CPB) will be 2.9 L/min/m2 throughout the CPB period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High CPB flowTarget CPB flow 2.9 L/min/m2 throughout the CPB period | Procedure or surgery | High CPB flow |
Primary outcome
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.
Biomarkers Nephrocheck
Time frame: 24 hours
Renal biomarker assay Nephrocheck (IGFBP-7 x TIMP-2) will be analyzed in urine
Renal oxygen delivery and blood flow
Time frame: 6 hours
Renal oxygen delivery during and after cardiopulmonary bypass (CPB)
13 secondary outcomes
Serum creatinine and acute kidney injury (AKI)
Time frame: 48 hours
Inflammation IL-1
Time frame: 24 hours
Inflammation IL-6
Time frame: 24 hours
Inflammation IL-8
Time frame: 24 hours
Inflammation IL-10
Time frame: 24 hours
Inflammation TNFa
Time frame: 24 hours
Complement activation
Time frame: 24 hours
Hemolysis
Time frame: 24 hours
Erythropoetin
Time frame: 24 hours
Neuroinflammation Tau
Time frame: 4 days
Neuroinflammation NF
Time frame: 4 days
Kidney function
Time frame: 24 hours
Renal function
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Background: PubMed 27906706Lannemyr L, Bragadottir G, Krumbholz V, Redfors B, Sellgren J, Ricksten SE. Effects of Cardiopulmonary Bypass on Renal Perfusion, Filtration, and Oxygenation in Patients Undergoing Cardiac Surgery. Anesthesiology. 2017 Feb;126(2):205-213. doi: 10.1097/ALN.0000000000001461.
- Results publication: PubMed 30365961Lannemyr L, Bragadottir G, Hjarpe A, Redfors B, Ricksten SE. Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation in Patients Undergoing Cardiac Operations. Ann Thorac Surg. 2019 Feb;107(2):505-511. doi: 10.1016/j.athoracsur.2018.08.085. Epub 2018 Oct 23.
- Results publication: PubMed 28748536Lannemyr L, Lundin E, Reinsfelt B, Bragadottir G, Redfors B, Oras J, Ricksten SE. Renal tubular injury during cardiopulmonary bypass as assessed by urinary release of N-acetyl-ss-D-glucosaminidase. Acta Anaesthesiol Scand. 2017 Oct;61(9):1075-1083. doi: 10.1111/aas.12946. Epub 2017 Jul 26.
- Derived from this study: PubMed 41838934Wijk J, Corderfeldt-Keiller A, Bragadottir G, Redfors B, Ricksten SE, Lannemyr L. Cardiopulmonary Bypass Flow Rate and the Kidney: Reply. Anesthesiology. 2026 May 1;144(5):1259-1260. doi: 10.1097/ALN.0000000000005957. Epub 2026 Mar 16. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Extracorporeal Circulation; Complications
RecruitingObservational study
Observational Study of Platelet Dysfunction Assessed by Thromboelastography in Cardiovascular Surgery (DISPLATEG)
Blood Platelet Disorders, Cardiac Surgery
Active, not recruitingObservational study
Effect of Minimally Invasive Extracorporeal Circulation on Optic Nerve Sheath Diameter and Stroke Incidence in Isolated Open Heart Surgery
Stroke, Cardiac Surgery
Recruiting
MiECC Versus Conventional Cardiopulmonary Bypass in Cardiac Surgery (MiECS)
Coronary Artery Disease, Aortic Valve Stenosis
Recruiting
Pilot Study on HA380 Column Use in Critically Ill Patients Receiving Extracorporeal Support.
Acute Kidney Injury, ARDS
Active, not recruitingPhase 3
Evaluation of the Superiority of VAsopressin Versus NOradrenaline in the Management of Patients at Risk of Kidney Failure Undergoing Cardiac Surgery With Extracorporeal Circulation
Scheduled Cardiac Surgery With Extracorporeal Circulation, Vasoplegic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High CPB flow in people with Extracorporeal Circulation; Complications and Renal Failure, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker u-NAG (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04084301, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.