AKI Cardiosurgery Diagnostic Study (AKI-CDS) (AKI-CDS)

Prospective Analysis of Postoperative Occurrence of Acute Kidney Injury (AKI) and Need for Renal Replacement Therapy After Cardiac Surgery With the Help of New Biomarkers.

Acute kidney injury (AKI) is a common and major complication of cardiac surgery. The aim of this study is to evaluate the use of a fragment of proencephalin in plasma and other biomarkers as specific markers for early diagnosis of AKI and the need of renal replacement therapy after cardiac surgery.

Study Overview

• Status: Unknown
• Conditions: Acute Kidney Injury; Renal Replacement Therapy
• Intervention / Treatment: Diagnostic test: Biomarker ("penKid", adrenomedulin, C-terminal alpha-1 antitrypsin peptide)

Detailed Description

Acute kidney injury (AKI) is an abrupt loss of kidney function and occurs in up to 5-40% of patients who undergo cardiac surgery; dialysis being required in approximately 2-15% of all patients. AKI is a common problem in critically ill patients and is independently from underlying diseases associated with increased morbidity and mortality (to progressive loss of kidney function, cardiovascular disease, and death). Unfortunately, chronic kidney disease is often overlooked in its earliest, most treatable stages. Implementation of novel biomarkers into the clinical practice that reliably identify patients at risk or at an early stage of AKI could offer more efficient management strategies may lead to better outcomes in critically ill patients.

Kidney disease usually progresses silently, often destroying most of the kidney function before causing any symptoms. AKI was defined using the Kidney Disease Improvement Global Outcome (KDIGO) definition. The standard key tests (increase of serum creatinine and urine output) are late parameters after significant kidney injury.

In this study 20 female and 20 male adult patients before and after cardiac surgery should be included. From all patients basic demographic data, pre-morbidity, vital parameters, blood parameters, urine output, Illness severity scores (APACHE-II, SOFA, GCS), drug levels, microbiological results will be recorded. The aim of this study is to evaluate the use of a fragment of proencephalin in plasma "penKID", Spingotec GmbH, Berlin, Germany) and other biomarkers (ADM: adrenomedulin, CAAP: C-terminal alpha-1 antitrypsin peptide) as specific markers for early diagnosis of AKI and the need of renal replacement therapy. Bio-ADM is a water-soluble peptide hormone with a molecular weight of about 6kDa released mainly by endothelial cells. Its biological function is the control of vasodilation, an important regulator of blood pressure and organ perfusion. This biomarker predicts and diagnoses endothelial dysfunctions. C-terminal alpha-1 antitrypsin peptide (CAAP) is a novel sepsis and renal injury biomarker with immunomodulatory function, especially in human neutrophils, which supports its role in the host response and pathophysiology of sepsis.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Germany
  • Rostock, Germany, 18055
    • Recruiting
    • Intensive Care Units PIT 1+2, University hospital Rostock
    • Contact: Martin Sauer, PD Dr.; Phone Number: +49 381 4946434; Email: martin.sauer@uni-rostock.de
    • Contact: Sandra Doß; Phone Number: +49 381 4942640; Email: sandra.doss@med.uni-rostock.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients undergoing cardiac surgery and fulfilling the inclusion criteria should be screened for the study at the university hospital of Rostock, Germany at one of the two different intensive care units PIT 1 and 2 at the Department of Anaesthesiology and Intensive Care or at the Department of Cardiac Surgery.

Description

Inclusion Criteria:

• Female or male, at least 18 years old
• Ability to consent to the study by patient or legal representative
• Cardiac surgery with use of extracorporeal circulation (ECC)
• Bypass (> 2; ACB) or bypass + heart valve surgery
• Two or three heart-valve operation

Exclusion Criteria:

• Dialysis-dependent patients with chronic, end-stage renal failure
• Pre-existing renal replacement therapy
• Infused prognosis (expected death in ≤ 12 hours despite maximal therapy)
• Inability to consent of participation in the research project, of the patient or of the patients representative
• Aortic surgery
• Endocarditis
• (Only) partial sternotomy (eg. aortic valve surgery)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Male; 20 male adult patients after cardiac surgery. Drawing of patients blood for measurement of biomarkers ("penKid", adrenomedulin, C-terminal alpha-1 antitrypsin peptide) for AKI before and after cardiac surgery (times: 0, 6, 24, 72, 168 hours).	Diagnostic test: Biomarker ("penKid", adrenomedulin, C-terminal alpha-1 antitrypsin peptide); Drawing of patients blood for measurement of biomarkers for AKI before and after cardiac surgery (times: 0, 6, 24, 72, 168 hours).
Female; 20 female adult patients after cardiac surgery. Drawing of patients blood for measurement of biomarkers ("penKid", adrenomedulin, C-terminal alpha-1 antitrypsin peptide) for AKI before and after cardiac surgery (times: 0, 6, 24, 72, 168 hours).	Diagnostic test: Biomarker ("penKid", adrenomedulin, C-terminal alpha-1 antitrypsin peptide); Drawing of patients blood for measurement of biomarkers for AKI before and after cardiac surgery (times: 0, 6, 24, 72, 168 hours).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AKI 0 h	Diagnosis and severity of acute kidney injury following the KDIGO-criteria	after operation (surgery): 0 hours
AKI 6 h	Diagnosis and severity of acute kidney injury following the KDIGO-criteria	after operation (surgery): 6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SOFA	SOFA-Score	before operation, after operation (times: 0, 6, 24, 72 and 168 hours

Collaborators and Investigators

• Sponsor: University of Rostock

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2018
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 15, 2018

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 4, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Cardiac Surgery; Acute Kidney Injury
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Serine Proteinase Inhibitors; Trypsin Inhibitors; Alpha 1-Antitrypsin; Protein C Inhibitor
• Other Study ID Numbers: A 2018-0092

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No