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NCT Number: NCT06730854

Association Between Liver Function Tests and Acute Kidney Injury in Cardiac Surgery Patients

A sudden decline in function of the kidneys is a common problem that can happen after heart surgery. It can have serious effects on a patient's recovery and long-term health, potentially leading to permanent kidney problems or heart-related issues. One of the main reasons kidney problems occurs is due to changes in blood flow caused by the heart not pumping well enough. These changes may harm the kidneys, but other organs as well such as the liver.

This study aims to find out if there is a relationship between elevated levels of liver function blood tests and the decline in kidney function.

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Key information

Conditions

Cardiac Surgery Associated - Acute Kidney Injury Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ghent university hospital

Ghent, Oost-Vlaanderen, 9000, Belgium

About this study

In this study data will be retrospectively collected from the intensive care patient management system for patients admitted postoperatively to the cardiac intensive care unit (ICU) following cardiac surgery. The inclusion period spans from 2012 to 2017 (5 years) and includes about 3,500 patients.

For all included patients, retrospective data collection will include variables related to renal function, fluid balance, hemodynamics, and transaminase levels. Additionally, demographic information, surgical procedure details, comorbidities, and laboratory values will be gathered.

Cardiac surgery-associated acute kidney injury (CSA-AKI) has a multifactorial etiology influenced by non-modifiable factors such as age, comorbidities (e.g., heart failure/ejection fraction, chronic kidney disease, hypertension, diabetes), medication use (NSAIDs, ACE inhibitors/ARBs), type of surgery, duration of surgery/cardiopulmonary bypass time. Central venous pressure (CVP) can serve as a marker of venous congestion, which may contribute to the development of AKI. Venous congestion may also result in elevated transaminase levels.

The primary aim of this study is to investigate the association between postoperative transaminase elevation in the ICU and the development of AKI during the intensive care stay. Data about transaminases will be collected in the first 24 hours after ICU admission. The occurrence of AKI and its severity will be investigated within 72 hours after cardiac surgery. Furthermore, the relationship between the transaminase elevation and the severity of acute kidney injury will be examined, as well as the association between central venous presure (CVP) and transaminase levels postoperatively in the ICU.

Acute kidney injury will be defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria, with severity classified based on the KDIGO staging system.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years old or older
  • admission on intensive care after cardiac surgery
  • available data about liver enzymes

Exclusion criteria

  • chronic kidney disease with (estimated) glomerular filtration rate below 30mL/min/1.73 m2 or renal replacement therapy (RRT) dependent
  • patient on extracorporal membrane oxygenator (ECMO) before or after cardiac surgery
  • patient with or planned surgery for Left ventricular assist device (LVAD)
  • inotropics or vasopressore before surgery

Treatment and study plan

Primary outcomes

  1. Association between liver enzymes and acute kidney injury

    Time frame: Data about liver enzymes will be collected at ICU admission, and 12 hours and 24 hours after ICU admission. The occurrence of acute kidney injury within 72 hours after ICU admission will be investigated

    Investigation of the association between liver enzymes (alanine aminotransferase (AST); aspartate aminotransferase (ALT)) and development of acute kidney injury. Data about liver enzymes will be collected at ICU admission, and 12 hours and 24 hours after ICU admission. AKI is defined by the Kidney Disease Improving global outcome definition by using both the serum creatinine and urine output criteria.

Secondary outcomes

  1. Association between liver enzymes and the severity of acute kidney injury

    Time frame: Data about liver enzymes will be collected at ICU admission, and 12 hours and 24 hours after ICU admission. The occurrence of the different severity stages of acute kidney injury within 72 hours after ICU admission will be investigated

    Investigation of the association between liver enzymes (alanine aminotransferase (AST); aspartate aminotransferase (ALT)) and the sevirity of the developed acute kidney injury. AKI severity is defined by the Kidney Disease Improving global outcome (KDIGO) classification: stage 1, stage 2 and stage 3. Stage 3 is the most severe form of kidney injury, including the use of renal replacement therapy (RRT)

  2. association of central venous pressure with elevated liver enzymes and acute kidney injury

    Time frame: Data about central venous pressure will be collected during the first 24 hours after ICU admission.

    Investigation of the association between elevated central venous pressure and elevation in liver enzymes (alanine aminotransferase (AST); aspartate aminotransferase (ALT)) and the development of acute kidney injury (severity)

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

Association Between Elevated Liver Functions Tests Following Cardiac Surgery and Acute Kidney Injury - a Restrospectiv Single Center Cohort Study

Acronym: TransAKI

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 12, 2024
Registry last updated
Dec 12, 2024

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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