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Acute kidney injury is a common complication after cardiac surgery with cardiopulmonary bypass (CPB). This study aims to investigate the effects of CPB on renal perfusion, filtration and oxygenation.
After approval of the regional ethics committee, patients (n=16) undergoing combined cardiac surgery procedures during normothermic CPB will be included after informed consent. Systemic and renal variables will be measured by pulmonary artery and renal vein catheters. Glomerular filtration rate (GFR) will be measured by renal extraction of 51Cr-EDTA and renal blood flow (RBF) by the infusion clearance technique for para-aminohippuric acid (PAH) corrected for by renal extraction of PAH. Repeated measures ANOVA followed by Fisher's PLSD post-hoc test were used for statistical analyses
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cardiopulmonary bypass | Procedure | During cardiac surgery, the subjects are routinely undergoing cardiopulmonary bypass |
|
| Measure | Description | Time Frame |
|---|---|---|
| Renal Blood Flow (RBF) | Renal blood flow measured with PAH clearance | 6 hours |
| Glomerular Filtration Rate (GFR) | GFR measured by renal extraction of 51Cr-EDTA | 6 hours |
| Renal Oxygenation | Renal oxygen extraction, defined as renal oxygen consumption divided by renal oxygen delivery | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Excretion of NAG | Urinary biomarker of tubular renal injury | 24 hours |
| Development of Acute Kidney Injury (AKI) | AKI according to AKIN criteria |
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Inclusion Criteria:
Exclusion Criteria:
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Elective complex cardiac surgery
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| Name | Affiliation | Role |
|---|---|---|
| Sven-Erik Ricksten, Professor | Sahlgrenska Academy, dept of clinical science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of thoracic anesthesia, Sahlgrenska University Hospital | Gothenburg | 41345 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31919012 | Derived | Lannemyr L, Bragadottir G, Redfors B, Ricksten SE. Effects of milrinone on renal perfusion, filtration and oxygenation in patients with acute heart failure and low cardiac output early after cardiac surgery. J Crit Care. 2020 Jun;57:225-230. doi: 10.1016/j.jcrc.2019.12.022. Epub 2020 Jan 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CardioPulmonaryBypass | Open cardiac surgery with normothermic Cardiopulmonary Bypass at 2.5 L/min/m2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CardioPulmonary Bypass | Open cardiac surgery with normothermic Cardiopulmonary Bypass at 2.5 L/min/m2. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Renal Blood Flow (RBF) | Renal blood flow measured with PAH clearance | Posted | Mean | Standard Deviation | ml per minute per 1.73 m2 body surface | 6 hours |
|
|
Three days
Postoperative acute kidney injury, defined as an increase in serum-creatinine ≥50 % from baseline.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CardioPulmonaryBypass | Open cardiac surgery with normothermic Cardiopulmonary Bypass at 2.5 L/min/m2. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment | Increase in serum-creatinine ≥50% from baseline |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lukas Lannemyr | Västra Götalandsregionen | 46313428860 | lukas.lannemyr@vgregion.se |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D002315 | Cardiopulmonary Bypass |
| D005112 | Extracorporeal Circulation |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| 72 hours |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Serum creatinine | Mean | Standard Deviation | micromol per litre |
|
| Left ventricular ejection fraction | Mean | Standard Deviation | % |
|
|
|
| Primary | Glomerular Filtration Rate (GFR) | GFR measured by renal extraction of 51Cr-EDTA | Posted | Mean | Standard Deviation | ml per minute per 1.73 m2 body surface | 6 hours |
|
|
|
|
| Primary | Renal Oxygenation | Renal oxygen extraction, defined as renal oxygen consumption divided by renal oxygen delivery | Posted | Mean | Standard Deviation | fraction | 6 hours |
|
|
|
|
| Secondary | Excretion of NAG | Urinary biomarker of tubular renal injury | Not Posted | 24 hours | Participants |
| Secondary | Development of Acute Kidney Injury (AKI) | AKI according to AKIN criteria | Not Posted | 72 hours | Participants |
| 0 |
| 18 |
| 0 |
| 18 |
| 4 |
| 18 |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
|
| Post CPB (30 - 60 minutes) |
|
|
| Post CPB (30 - 60 minutes) |
|