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

NCT04084301 | Completed

• 1 other identifier: ICAROX2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

renal oxygenation; renal blood flow; cardiopulmonary bypass; tubular cell injury; N-acetyl-beta-D-glucosaminidase; nephrocheck; inflammation; hemolysis

Outcome Measures

Primary Outcomes (3)

• 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.

  24 hours

• Biomarkers Nephrocheck

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

  24 hours

• Renal oxygen delivery and blood flow

  Renal oxygen delivery during and after cardiopulmonary bypass (CPB)

  6 hours

Secondary Outcomes (13)

• Serum creatinine and acute kidney injury (AKI)

  48 hours

• Inflammation IL-1

  24 hours

• Inflammation IL-6

  24 hours

• Inflammation IL-8

  24 hours

• Inflammation IL-10

  24 hours

Other Outcomes (1)

• Urinary pO2

  24 hours

Study Arms (2)

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.

Procedure: High CPB flow

Interventions

High CPB flow PROCEDURE

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

High CPB flow

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Lukas Lannemyr

Gothenburg, Västra Götaland County, 416 53, Sweden

Location

Related Publications (3)

• 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.

  PMID: 27906706 BACKGROUND

• Lannemyr 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.

  PMID: 30365961 RESULT

• Lannemyr 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.

  PMID: 28748536 RESULT

MeSH Terms

Conditions

Renal Insufficiency; Hemolysis; Gangliosidoses, GM2; Inflammation

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gangliosidoses; Sphingolipidoses; Lysosomal Storage Diseases, Nervous System; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lipidoses; Lipid Metabolism, Inborn Errors; Lysosomal Storage Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist of Anesthesia and Intensive care

Model Details: To compare normal (2.4 L/min/m2) and high (2.9 L/min/m2) cardiopulmonary bypass flow during cardiac surgery

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: September 10, 2019
• Study Start: September 27, 2019
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)