AKI Cardiosurgery Diagnostic Study (AKI-CDS)

NCT ID: NCT03632538

Last Updated: 2020-04-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-27
• Study Completion Date: 2021-10-31

Brief Summary

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.

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.

Conditions

Acute Kidney Injury; Renal Replacement Therapy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Biomarker ("penKid", adrenomedulin, C-terminal alpha-1 antitrypsin peptide)

Intervention Type: DIAGNOSTIC_TEST

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).

Biomarker ("penKid", adrenomedulin, C-terminal alpha-1 antitrypsin peptide)

Intervention Type: DIAGNOSTIC_TEST

Drawing of patients blood for measurement of biomarkers for AKI before and after cardiac surgery (times: 0, 6, 24, 72, 168 hours).

Interventions

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).

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rostock

OTHER

Sponsor Role: lead

Responsible Party

Dr. Martin Sauer, MD

Principal Investigator, PD Dr. med. habil.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Sauer, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Rostock, Germany

Locations

Intensive Care Units PIT 1+2, University hospital Rostock

Rostock, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Martin Sauer, MD

Role: CONTACT

martin.sauer@uni-rostock.de

+493814946409

Sandra Doß

Role: CONTACT

sandra.doss@med.uni-rostock.de

+493814942640

Facility Contacts

Martin Sauer, PD Dr.

Role: primary

martin.sauer@uni-rostock.de

+49 381 4946434

Sandra Doß

Role: backup

sandra.doss@med.uni-rostock.de

+49 381 4942640

Other Identifiers

A 2018-0092

Identifier Type: -

Identifier Source: org_study_id