New Markers of Cardiac Surgery Related Acute Kidney Injury.

Completed

• Conditions: Acute Kidney Injury; Cardiac Disease
• Interventions: Diagnostic Test: urine and blood analysis

• Registration Number: NCT03860545
• Lead Sponsor: Pomeranian Medical University Szczecin

Brief Summary

Cardiac surgery related acute kidney injury (CS-AKI) is a clinical problem associated with a cardiopulmonary bypass used during cardiac surgery procedures. In this study the investigators will assess the biochemical markers of acute kidney injury such as ischemia modified albumin (IMA) or urinary excreted of brush-border enzymes of the proximal renal tubules perioperatively. There has been no official recommendations toward routine use of analysed biomarkers.

Detailed Description

Cardiac surgery related acute kidney injury (CS-AKI) is an important clinical problem. Kidney injury occurs following a cardiopulmonary bypass used during cardiac surgery procedures. The pathomechanisms of acute kidney injury (AKI) is complex and multifactorial. It may involve few injury pathways: ischemia and reperfusion, endogenous toxins, inflammation, metabolic factors and oxidative stress. Biochemical markers of acute kidney injury such as ischemia modified albumin (IMA) or urinary excreted of brush-border enzymes of the proximal renal tubules analysed perioperatively will be assessed in this study. There has been no official recommendations toward routine use of analysed biomarkers.

Study Timeline

• Study Start: 2018-01-02
• Status Verified: 2019-02
• Primary Completion: 2019-02-26
• Study Completion: 2019-02-26
• Study First Submitted: 2019-02-26
• Study First Submitted QC: 2019-02-28
• Last Update Submitted: 2019-02-28
• Study First Posted: 2019-03-04
• Last Update Posted: 2019-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• a planned operation of coronary artery bypass grafting with the use of cardiopulmonary bypass

Exclusion Criteria

• emergency operations or re-operations;
• a known pathology of the urinary tract or renal failure;
• chronic use of the following medications: iron, non-steroidal anti-inflammatory drugs (NSAIDs), immunosuppression, or steroids in the preoperative period;
• polycythemia, porphyria or pathological hemoglobin species in anamnesis;
• preoperative signs of hepatic failure;
• active autoimmune or neoplastic diseases, active infection;
• anticipated significant bleeding (anti-platelet agents), suggesting the use of blood-derived products during the operation and afterward
• acute myocardial infarction after operation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AKI	urine and blood analysis	patient with diagnosis acute kidney injury (AKI) established during perioperative observation period
non-AKI	urine and blood analysis	patient without acute kidney injury (AKI) during perioperative observation period

Primary Outcome Measures

Name	Time	Method
acute kidney injure after operation	up to 48 hours post operation	acute kidney injure measured by urine output in ml

Trial Locations

Locations (1)

Pomeranian Medical University; 🇵🇱 Szczecin, Poland