Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery

NCT06109714 | Not Yet Recruiting DMC

• 1 other identifier: HP-00100950
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Renal Injury; Acute Kidney Injury

Keywords

Cardiac Surgery; Cardiac Surgery Induced Kidney Injury; Kidney Biomarkers

Outcome Measures

Primary Outcomes (2)

• Acute Kidney Injury

  KIDIGO Criteria for AKI

  7 days or discharge whichever occurs first

• Renal Biomarkers

  NGAL, Hepcidin-25, and Uromodulin

  48 hours postoperatively

Secondary Outcomes (5)

• Total Fluid Administered

  From initiation of surgery to 48 hours postoperatively

• ICU Length of Stay

  From admission to the intensive care unit until discharge or 20 weeks whichever comes first.

• Hemodynamic Support Usage

  During the first 48 hours postoperatively

• Morbidity and Mortality

  30 days

• Blood Transfusions

  From surgical incision to 48 hours postoperatively

Study Arms (2)

ACUMEN guided resuscitation protocol

EXPERIMENTAL

Fluid resuscitation and hemodynamic management will be guided by ACUMEN based off a protocol.

Other: Goal Directed Fluid Therapy

Standard of care resuscitation

NO INTERVENTION

Fluid resuscitation will be guided by standard monitors (urine output, blood loss, transesophageal echocardiography).

Interventions

Goal Directed Fluid Therapy OTHER

Fluid administration and hemodynamic management guided with the assistance of Edwards Lifesciences ACUMEN monitor

ACUMEN guided resuscitation protocol

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients undergoing cardiopulmonary bypass
• Procedure coronary artery bypass grafting, aortic valve replacement, or both

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Related Publications (4)

• 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.

  PMID: 32265240 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.

  PMID: 31303781 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.

  PMID: 35039910 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.

  PMID: 29858368 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Reney A Henderson, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reney A Henderson, MD

CONTACT

4103283961; rhenderson@som.umaryland.edu

LaToya Stubbs

CONTACT

4103289951; lstubbs@som.umaryland.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: October 31, 2023
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share