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This study is to assess the benefits of goal-directed fluid management with ACUMEN in cardiac surgical patients and its impact on cardiac surgery-induced kidney injury.
This study is to assess the benefits of goal-directed fluid management with ACUMEN in cardiac surgical patients undergoing a CABG, AVR, or CABG/AVR. Kidney injury biomarkers NGAL, Uromodulin, and Hepcidin-25 will be used to assess cardiac-induced kidney injury. Patients will be randomly enrolled in either standard care for fluid management or goal-directed fluid management with ACUMEN.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACUMEN guided resuscitation protocol | Experimental | Fluid resuscitation and hemodynamic management will be guided by ACUMEN based off a protocol. |
|
| Standard of care resuscitation | No Intervention | Fluid resuscitation will be guided by standard monitors (urine output, blood loss, transesophageal echocardiography). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goal Directed Fluid Therapy | Other | Fluid administration and hemodynamic management guided with the assistance of Edwards Lifesciences ACUMEN monitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute Kidney Injury | KIDIGO Criteria for AKI | 7 days or discharge whichever occurs first |
| Renal Biomarkers | NGAL, Hepcidin-25, and Uromodulin | 48 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Total Fluid Administered | intraoperative and postoperative volume given measured in milliliters | From initiation of surgery to 48 hours postoperatively |
| ICU Length of Stay | Quantified in days and hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reney A Henderson, MD | Contact | 4103283961 | rhenderson@som.umaryland.edu | |
| LaToya Stubbs | Contact | 4103289951 | lstubbs@som.umaryland.edu |
| Name | Affiliation | Role |
|---|---|---|
| Reney A Henderson, MD | University of Maryland, Baltimore | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32265240 | Background | Kullmar M, Massoth C, Ostermann M, Campos S, Grau Novellas N, Thomson G, Haffner M, Arndt C, Wulf H, Irqsusi M, Monaco F, Di Prima A, Garcia Alvarez M, Italiano S, Cegarra SanMartin V, Kunst G, Nair S, L'Acqua C, Hoste EAJ, Vandenberghe W, Honore PM, Kellum J, Forni L, Grieshaber P, Weiss R, Gerss J, Wempe C, Meersch M, Zarbock A. Biomarker-guided implementation of the KDIGO guidelines to reduce the occurrence of acute kidney injury in patients after cardiac surgery (PrevAKI-multicentre): protocol for a multicentre, observational study followed by randomised controlled feasibility trial. BMJ Open. 2020 Apr 6;10(4):e034201. doi: 10.1136/bmjopen-2019-034201. | |
| 31303781 |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| From admission to the intensive care unit until discharge or 20 weeks whichever comes first. |
| Hemodynamic Support Usage | Vasopressor or Inotrope usage | During the first 48 hours postoperatively |
| Morbidity and Mortality | Death and Major adverse events (cerebral vascular stroke, myocardial infarction, infection, prolonged intubation > 24 hours) | 30 days |
| Blood Transfusions | Any Allogeneic Blood Transfusions | From surgical incision to 48 hours postoperatively |
| Background |
| Vives M, Hernandez A, Parramon F, Estanyol N, Pardina B, Munoz A, Alvarez P, Hernandez C. Acute kidney injury after cardiac surgery: prevalence, impact and management challenges. Int J Nephrol Renovasc Dis. 2019 Jul 2;12:153-166. doi: 10.2147/IJNRD.S167477. eCollection 2019. |
| 35039910 | Background | Van den Eynde J, Schuermans A, Verbakel JY, Gewillig M, Kutty S, Allegaert K, Mekahli D. Biomarkers of acute kidney injury after pediatric cardiac surgery: a meta-analysis of diagnostic test accuracy. Eur J Pediatr. 2022 May;181(5):1909-1921. doi: 10.1007/s00431-022-04380-4. Epub 2022 Jan 17. |
| 29858368 | Background | Nadim MK, Forni LG, Bihorac A, Hobson C, Koyner JL, Shaw A, Arnaoutakis GJ, Ding X, Engelman DT, Gasparovic H, Gasparovic V, Herzog CA, Kashani K, Katz N, Liu KD, Mehta RL, Ostermann M, Pannu N, Pickkers P, Price S, Ricci Z, Rich JB, Sajja LR, Weaver FA, Zarbock A, Ronco C, Kellum JA. Cardiac and Vascular Surgery-Associated Acute Kidney Injury: The 20th International Consensus Conference of the ADQI (Acute Disease Quality Initiative) Group. J Am Heart Assoc. 2018 Jun 1;7(11):e008834. doi: 10.1161/JAHA.118.008834. No abstract available. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |