Clinical trial NCT06730854: Association Between Liver Function Tests and Acute Kidney Injury in Cardiac Surgery Patients
Official title: Association Between Elevated Liver Functions Tests Following Cardiac Surgery and Acute Kidney Injury - a Restrospectiv Single Center Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgery Associated - Acute Kidney Injury
Acute Kidney Injury
Keywords: liver enzymes
acute kidney injury
cardiac surgery
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 3415
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The cardiac surgery patients screened for eligibility were admitted on the cardiac surgery intensive care unit of Ghent University hospital between 1 Januari 2012 until 31 december 2017

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Association between liver enzymes and acute kidney injury
timeFrame: 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
Secondary outcomes:
measure: Association between liver enzymes and the severity of acute kidney injury
timeFrame: 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
measure: association of central venous pressure with elevated liver enzymes and acute kidney injury
timeFrame: Data about central venous pressure will be collected during the first 24 hours after ICU admission.
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent university hospital
state: Oost-Vlaanderen
Study officials:
affiliation: University Hospital, Ghent
name: Wim Vandenberghe, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References: