NCT06730854

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,415

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2024

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 12, 2024

Completed
Last Updated

December 12, 2024

Status Verified

November 1, 2024

Enrollment Period

Same day

First QC Date

November 26, 2024

Last Update Submit

December 11, 2024

Conditions

Keywords

liver enzymesacute kidney injurycardiac surgery

Outcome Measures

Primary Outcomes (1)

  • Association between liver enzymes and acute kidney injury

    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.

    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 (2)

  • Association between liver enzymes and the severity of acute kidney injury

    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

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

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

Study Arms (1)

Main cohort of patient

In the included patients the occurrence of acute kidney injury (AKI) will be investigated. So patient will be grouped as 'no AKI' and 'AKI' For the subanalysis, patient will be grouped according to their admission central venous pressure. There are no interventions.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent university hospital

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Wim Vandenberghe, MD; PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2024

First Posted

December 12, 2024

Study Start

November 6, 2024

Primary Completion

November 6, 2024

Study Completion

November 6, 2024

Last Updated

December 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Due to European Data Protection regulation, no individual participant data will be shared, only the analysed data.

Locations