BE-KIND: Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery

• Sponsor: University of Maryland, Baltimore (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06109714
• Collaborator: (none)
• Enrollment: 100
• Arms: 2
• Anticipated Duration (Months): 46.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Injury; Acute Kidney Injury	Other: Goal Directed Fluid Therapy	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Diagnostic
• Official Title: Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
• Anticipated Study Start Date: Feb 1, 2024
• Anticipated Primary Completion Date: Apr 1, 2027
• Anticipated Study Completion Date: Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ACUMEN guided resuscitation protocol Fluid resuscitation and hemodynamic management will be guided by ACUMEN based off a protocol.	Other: Goal Directed Fluid Therapy; Fluid administration and hemodynamic management guided with the assistance of Edwards Lifesciences ACUMEN monitor
No Intervention: Standard of care resuscitation Fluid resuscitation will be guided by standard monitors (urine output, blood loss, transesophageal echocardiography).

Outcome Measures

Primary Outcome Measures

1. Acute Kidney Injury [7 days or discharge whichever occurs first]

   KIDIGO Criteria for AKI

2. Renal Biomarkers [48 hours postoperatively]

   NGAL, Hepcidin-25, and Uromodulin

Secondary Outcome Measures

1. Total Fluid Administered [From initiation of surgery to 48 hours postoperatively]

   intraoperative and postoperative volume given measured in milliliters

2. ICU Length of Stay [From admission to the intensive care unit until discharge or 20 weeks whichever comes first.]

   Quantified in days and hours

3. Hemodynamic Support Usage [During the first 48 hours postoperatively]

   Vasopressor or Inotrope usage

4. Morbidity and Mortality [30 days]

   Death and Major adverse events (cerebral vascular stroke, myocardial infarction, infection, prolonged intubation > 24 hours)

5. Blood Transfusions [From surgical incision to 48 hours postoperatively]

   Any Allogeneic Blood Transfusions

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Adult patients undergoing cardiopulmonary bypass

• Procedure coronary artery bypass grafting, aortic valve replacement, or both

Exclusion Criteria:

• Patients < 18 years old

• Emergent surgery

• Preoperative kidney disease (Cr > 2.0 or on renal replacement therapy)

• Ejection fraction < 40%

• Incomplete data in medical record

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Maryland, Baltimore

Investigators

• Principal Investigator: Reney A Henderson, MD, University of Maryland, Baltimore

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: Reney Henderson, Assistant Professor, University of Maryland, Baltimore
• ClinicalTrials.gov Identifier: NCT06109714
• Other Study ID Numbers: HP-00100950
• First Posted: Oct 31, 2023
• Last Update Posted: Oct 31, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Reney Henderson, Assistant Professor, University of Maryland, Baltimore: Cardiac Surgery; Cardiac Surgery Induced Kidney Injury; Kidney Biomarkers
• Additional relevant MeSH terms: Acute Kidney Injury; Wounds and Injuries

Study Results

No Results Posted as of Oct 31, 2023