New Markers of Cardiac Surgery Related Acute Kidney Injury.

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03860545
• Other study ID #: KB - 0012/146/10
• Status: Completed
• Start date: January 2, 2018
• Est. completion date: February 26, 2019

Study information

• Verified date: February 2019
• Source: Pomeranian Medical University Szczecin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: February 26, 2019
• Est. primary completion date: February 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cardiac Disease
• Heart Diseases
• Wounds and Injuries

Intervention

Diagnostic Test:
• urine and blood analysis
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

Locations

Country	Name	City	State
Poland	Pomeranian Medical University	Szczecin

Sponsors (1)

Lead Sponsor	Collaborator
Pomeranian Medical University Szczecin

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acute kidney injure after operation	acute kidney injure measured by creatinine concentration mg/dl	up to 48 hours post operation
Primary	acute kidney injure after operation	acute kidney injure measured by urine output in ml	up to 48 hours post operation