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

NCT ID: NCT04084301

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-27

Study Completion Date

2023-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

To compare normal (2.4 L/min/m2) and high (2.9 L/min/m2) cardiopulmonary bypass flow during cardiac surgery
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Normal CPB flow

In this group, the target flow during cardiopulmonary bypass (CPB) will be 2.4 L/min/m2 throughout the CPB period.

Group Type NO_INTERVENTION

No interventions assigned to this group

High CPB flow

In this group, the target flow during cardiopulmonary bypass (CPB) will be 2.9 L/min/m2 throughout the CPB period.

Group Type EXPERIMENTAL

High CPB flow

Intervention Type PROCEDURE

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

Interventions

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High CPB flow

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lukas Lannemyr

Specialist of Anesthesia and Intensive care

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lukas Lannemyr

Gothenburg, Västra Götaland County, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 27906706 (View on PubMed)

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.

Reference Type RESULT
PMID: 30365961 (View on PubMed)

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.

Reference Type RESULT
PMID: 28748536 (View on PubMed)

Other Identifiers

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ICAROX2

Identifier Type: -

Identifier Source: org_study_id