New Markers of Cardiac Surgery Related Acute Kidney Injury.

The New Biochemical 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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury; Cardiac Disease
• Intervention / Treatment: Diagnostic test: urine and blood analysis

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 Type: Observational
• Enrollment (Actual): 88

Contacts and Locations

Study Locations

• Poland
  • Szczecin, Poland, 70-204
    • Pomeranian Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will be divided into 2 groups regarding postoperative acute kidney injury

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
non-AKI; patient without acute kidney injury (AKI) during perioperative observation period	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
AKI; patient with diagnosis acute kidney injury (AKI) established during perioperative observation period	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
acute kidney injure after operation	acute kidney injure measured by creatinine concentration mg/dl	up to 48 hours post operation
acute kidney injure after operation	acute kidney injure measured by urine output in ml	up to 48 hours post operation

Collaborators and Investigators

• Sponsor: Pomeranian Medical University Szczecin

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 2, 2018
• Primary Completion (ACTUAL): February 26, 2019
• Study Completion (ACTUAL): February 26, 2019

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: February 28, 2019
• First Posted (ACTUAL): March 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 4, 2019
• Last Update Submitted That Met QC Criteria: February 28, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: ischemia modified albumin; Acute Kidney Injury, cardiopulmonary bypass; brush-border enzymes of the proximal renal tubules
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Heart Diseases; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: KB - 0012/146/10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: encoded in database of principal investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No