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Completed

NCT Number: NCT03860545

New Markers of Cardiac Surgery Related Acute Kidney Injury.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pomeranian Medical University

Szczecin, 70-204, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

urine and blood analysis

Diagnostic Test

concentration of ischemia modified albumin assessed in blood before operation, immediately and one hour after cardiopulmonary bypass, 24 hours after operation; concentration of urinary excretion of brush-border enzymes of the proximal renal tubules assessed before operation, immediately and one hour after cardiopulmonary bypass, 24 hours after operation, serum creatinine levels will be evaluated on the day of the operation and 24 h and 48 h postoperatively

Primary outcomes

  1. acute kidney injure after operation

    Time frame: up to 48 hours post operation

    acute kidney injure measured by creatinine concentration mg/dl

  2. acute kidney injure after operation

    Time frame: up to 48 hours post operation

    acute kidney injure measured by urine output in ml

Sponsors and collaborators

Lead sponsor

Pomeranian Medical University Szczecin

Other

Registry information

Official study title

The New Biochemical Markers of Cardiac Surgery Related Acute Kidney Injury.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 4, 2019
Registry last updated
Mar 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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