New Markers of Cardiac Surgery Related Acute Kidney Injury.

NCT ID: NCT03860545

Last Updated: 2019-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-02

Study Completion Date

2019-02-26

Brief Summary

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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

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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.

Conditions

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Acute Kidney Injury Cardiac Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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non-AKI

patient without acute kidney injury (AKI) during perioperative observation period

urine and blood analysis

Intervention Type 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

AKI

patient with diagnosis acute kidney injury (AKI) established during perioperative observation period

urine and blood analysis

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pomeranian Medical University Szczecin

OTHER

Sponsor Role lead

Responsible Party

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Jowita Biernawska

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pomeranian Medical University

Szczecin, , Poland

Site Status

Countries

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Poland

Other Identifiers

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KB - 0012/146/10

Identifier Type: -

Identifier Source: org_study_id

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