Biomarker-guided Intervention to Prevent Acute Kidney Injury

NCT04647396 | Completed DMC

• 1 other identifier: 07-AnIt-20
• Study Type: interventional
• Target: 1,180
• Locations: 7 countries
• Sites: 37

Brief Summary

There is no specific therapy for acute kidney injury. It is presumed that supportive measures improve the care and outcome of patients with acute kidney injury. The investigators hypothesize that the implementation of a bundle of supportive measures adapted to patients undergoing major surgery reduces the occurrence of AKI. This randomized prospective multicenter trial is needed to investigator whether the implementation of the bundle of measures is effective to prevent AKI in high risk patients undergoing major surgery.

Conditions

Acute Kidney Injury

Keywords

biomarker

Outcome Measures

Primary Outcomes (1)

• Occurence of moderate or severe AKI

  72 hours after start of intervention

Secondary Outcomes (14)

• Adherence to the implementation of the KDIGO-bundle

  72 hours after start of intervention

• Severity of AKI

  3 days after start of intervention

• Changes in biomarker values

  12 hours after start of intervention

• Free-days of mechanical ventilation

  up to 3 days after start of intervention

• Free-days of vasopressors

  up to 3 days after start of intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

Other: Comprehensive Implementation of the Bundle recommended by the "Kidney Disease: Improving Global Outcomes Group" (KDIGO bundle)

Control group

NO INTERVENTION

Interventions

Comprehensive Implementation of the Bundle recommended by the "Kidney Disease: Improving Global Outcomes Group" (KDIGO bundle) OTHER

Implementation of the KDIGO bundle for at least 12 hours 1. discontinuation of all nephrotoxic drugs when possible 2. optimization of volume status and hemodynamic parameters (consideration of a functional hemodynamic monitoring) 3. close monitoring of serum creatinine, fluid balance and urinary output 4. avoidance of hyperglycemia 5. considerations of alternatives to radiocontrast agents 6. discontinuation of angiotensin converting enzyme inhibitors and angiotensin receptor blockers in the perioperative period 7. avoidance of HES, gelatin, and chlorid-rich solutions

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients after major surgery who need to be admitted to the ICU
• Age \> 18 years
• \[TIMP-2\]\*\[IGFBP7\] ≥ 0.3 4-18 hours after surgery
• Inserted jugular central venous line and a urinary catheter
• Written informed consent.
• At least one additional risk factor for AKI
• Age \> 75 years
• Critical illness such as ongoing requirement of vasopressor support and/or mechanical ventilation postoperatively
• Pre-existing chronic kidney disease (eGFR\<60ml/min)
• Intraoperative use of radio contrast agents.

You may not qualify if:

• Pregnancy or breastfeeding
• Pre- existing high stages of chronic kidney disease (stage 4 or 5 i.e. eGFR \< 15 ml/ min)
• Kidney transplant within the last 12 month
• Known (Glomerulo-) Nephritis, interstitial nephritis or vasculitis
• Preexisting AKI
• Renal replacement therapy (RRT) within the last 90 days
• Participation in another intervention trial that investigates a drug/intervention that affects kidney function
• Persons held in an institution by legal or official order
• Persons with any kind of dependency on the investigator or employed by the responsible institution or investigator

Sponsors & Collaborators

• University Hospital Muenster: lead
• BioMérieux: collaborator

Study Sites (37)

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, France

Location

Service d´Anesthésie-Réanimation, Hôpital Edouard Herriot, Hospices Civils de Lyon

Lyon, France

Location

Centre Hospitalier Universitaire de Reims

Reims, France

Location

Department of Anaesthesiology and Intensive Care Medicine, Klinikum Bayreuth GmbH

Bayreuth, Germany

Location

Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Knappschaftskrankenhaus, Ruhr University Bochum

Bochum, Germany

Location

Department of Anesthesiology and Intensive Care Medicine, University Hospital Bonn

Bonn, Germany

Location

Department of Anesthesiology, Intensive Care and Pain Medicine, Klinikum Dortmund

Dortmund, Germany

Location

Department of Anesthesiology and Intensive Care Medicine, University Hospital "Carl Gustav Carus", Technische Universität Dresden

Dresden, Germany

Location

Department of Anesthesiology, University Hospital Düsseldorf, Heinrich-Heine-University Duesseldorf

Düsseldorf, Germany

Location

Department of Anesthesiology and Intensive Care Medicine, University Hospital Essen, University Duisburg-Essen

Essen, Germany

Location

Department of Anesthesiology, University Medical Center, Georg-August-University

Göttingen, Germany

Location

Department of Anesthesiology, Heidelberg University Hospital

Heidelberg, Germany

Location

Department of Anesthesiology and Intensive Care Medicine, Philipps-University

Marburg, Germany

Location

Department of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital

Münster, Germany

Location

Department of Anesthesiology, Department of Anesthesiology and Critical Care, Franziskus Hospital Münster

Münster, Germany

Location

Department of Anesthesiology and Intensive Care Medicine, University Hospital Tübingen, Eberhard Karls University Tübingen

Tübingen, Germany

Location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy

Location

Department of Translational Medicine and for Romagna, St. Anne's Archbishop Hospital, University of Ferrara

Ferrara, Italy

Location

Department of Health Sciences, Section of Anesthesiology, Intensive Care and Pain Medicine, University of Florence; Department of Anesthesia and Intensive Care, Section of Oncological Anesthesia and Intensive care, Azienda Ospedaliero Careggi

Florence, Italy

Location

Santa Chiara Regional Hospital, APSS Trento

Trento, Italy

Location

Department of Anesthesiology and Intensive Care, San Bortolo Hospital

Vicenza, Italy

Location

Department of Anaesthesiology, Laboratory of Experimental Intensive Care and Anaesthesiology (L.E.I.C.A.), Amsterdam UMC, Location Academic Medical Centre (AMC), Amsterdam, University of Amsterdam

Amsterdam, Netherlands

Location

Department of Anaesthesiology and Intensive Care Medicine, Parc de Salut Mar

Barcelona, Spain

Location

Hospital de Igualada

Barcelona, Spain

Location

Department of Anesthesia and Perioperative Care, Infanta Leonor University Hospital

Madrid, Spain

Location

Department of Anesthesiology, Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Hospital 12 de Octubre

Madrid, Spain

Location

Hospital Clínico San Carlos de Madrid

Madrid, Spain

Location

Servicio de Anestesiologia y Reanimación, Hosp. Universitario de La Princesa

Madrid, Spain

Location

Department of Anaesthesiology and Surgical Critical Care, Hospital Universitario Marqués de Valdecilla

Santander, Spain

Location

Hospital Universitario Virgen Macarena

Seville, Spain

Location

Adult Intensive Care Unit, Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Switzerland

Location

Centre for Experimental Medicine, School of Medicine, Dentistry, and Biomedical Sciences, Queen's University Belfast

Belfast, United Kingdom

Location

Intensive Care Unit, Royal Surrey County Hospital

Guildford, United Kingdom

Location

Department of Anaesthetics and Critical Care, Harefield Hospital

Harefield, United Kingdom

Location

Intensive Care Unit, Royal Liverpool University Hospital

Liverpool, United Kingdom

Location

Department of Critical Care, King's College London, Guy's & St Thomas' Hospital

London, United Kingdom

Location

Related Publications (3)

• Zarbock A, Ostermann M, Forni L, Bode C, Wild L, Putensen C, Roux DP, Martin EE, Arndt C, Rahmel T, de Rosa S, Monard C, Schneider AG, Glass A, Jung-Konig M, Romagnoli S, Gossage J, Lumlertgul N, Haaker JG, Ripolles-Melchor J, Spadaro S, Siniscalchi A, Futier E, Aupetitgendre L, Bhathal IR, Alvarez RG, Bernard A, Rosenberger P, Wempe C, Sadjadi M, Meersch M, Fischhuber K, Bellomo R, Kellum JA, von Groote T; BigpAK-2 study group. A preventive care strategy to reduce moderate or severe acute kidney injury after major surgery (BigpAK-2); a multinational, randomised clinical trial. Lancet. 2025 Dec 13;406(10521):2782-2791. doi: 10.1016/S0140-6736(25)01717-9. Epub 2025 Nov 13.

  PMID: 41242333 DERIVED

• von Groote T, Danzer MF, Meersch M, Zarbock A, Gerss J; BigpAK-2 study group. Statistical analysis plan for the biomarker-guided intervention to prevent acute kidney injury after major surgery (BigpAK-2) study: An international randomised controlled multicentre trial. Crit Care Resusc. 2024 Jun 21;26(2):80-86. doi: 10.1016/j.ccrj.2024.03.001. eCollection 2024 Jun.

  PMID: 39072240 DERIVED

• von Groote T, Meersch M, Romagnoli S, Ostermann M, Ripolles-Melchor J, Schneider AG, Vandenberghe W, Monard C, De Rosa S, Cattin L, Rahmel T, Adamzik M, Parise D, Candela-Toha A, Haaker JG, Gobel U, Bernard A, Lumlertgul N, Fernandez-Valdes-Bango P, Romero Bhathal I, Suarez-de-la-Rica A, Larmann J, Villa G, Spadaro S, Wulf H, Arndt C, Putensen C, Garcia-Alvarez R, Brandenburger T, Siniscalchi A, Ellerkmann R, Espeter F, Porschen C, Sadjadi M, Saadat-Gilani K, Weiss R, Gerss J, Kellum J, Zarbock A; BigpAK-2 Investigators. Biomarker-guided intervention to prevent acute kidney injury after major surgery (BigpAK-2 trial): study protocol for an international, prospective, randomised controlled multicentre trial. BMJ Open. 2023 Mar 27;13(3):e070240. doi: 10.1136/bmjopen-2022-070240.

  PMID: 36972972 DERIVED

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

• Zarbock, MD

  University Hospital Muenster, Dept. of Anesthesiology, Intensive Care Medicine and Pain Therapy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: November 30, 2020
• Study Start: November 17, 2020
• Primary Completion: June 24, 2024
• Study Completion: September 9, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3); NL (1); ES (9); IT (5); GB (5); DE (13); CH (1)