AKI Cardiosurgery Diagnostic Study (AKI-CDS)

Acute Kidney Injury Clinical Trial

— AKI-CDS  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03632538
• Other study ID #: A 2018-0092
• Status: Recruiting
• Start date: July 27, 2018
• Est. completion date: October 2021

Study information

• Verified date: April 2020
• Source: University of Rostock
• Contact: Martin Sauer, MD
• Phone: +493814946409
• Email: martin.sauer[@]uni-rostock.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2021
• Est. primary completion date: July 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Kidney Injury
• Renal Replacement Therapy

Intervention

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).

Locations

Country	Name	City	State
Germany	Intensive Care Units PIT 1+2, University hospital Rostock	Rostock

Sponsors (1)

Lead Sponsor	Collaborator
University of Rostock

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AKI 0 h	Diagnosis and severity of acute kidney injury following the KDIGO-criteria	after operation (surgery): 0 hours
Primary	AKI 6 h	Diagnosis and severity of acute kidney injury following the KDIGO-criteria	after operation (surgery): 6 hours
Secondary	SOFA	SOFA-Score	before operation, after operation (times: 0, 6, 24, 72 and 168 hours