Acute Kidney InjuryNCT05637424
Urine Biomarkers to Predict Acute Kidney Injury After Pediatric Cardiac Surgery
An observational study of Acute Kidney Injury and Congenital Cardiac Disorders, run by University Ghent.
Trial summary
The goal of this prospective cohort study is to evaluate, in pediatric patients after cardiac surgery, the predicting capability of biomarkers for acute kidney injury. The main questions it aims to answer: The predicting capability of acute kidney injury (AKI) biomarkers for the primary endpoint: the occurrence of AKI… Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Acute Kidney Injury, Congenital Cardiac Disorders
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2012to 23 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- Child
Study population: Pediatric patients (age <18 years with body weight ≥ 2 kg) who underwent elective cardiac suregry, prospective enrolled preoperatively at Ghent University hospital. Exclusion criteria were AKI stage ≥1 on admission, chronic kidney disease (CKD) stage 5, kidney transplantation, surgery during weekend
Who may be able to join
- pediatric patients (age <18 years with body weight ≥ 2 kg)
- patient underwent elective cardiac surgery
Who cannot join
- AKI stage ≥1 on admission
- chronic kidney disease (CKD) stage 5
- kidney transplantation
- cardiac surgery during weekend
About this study
Official title: Potential of Urine Biomarkers CHI3L1, NGAL, TIMP-2, IGFBP7 and Combinations as Complementary Diagnostic Tools for Acute Kidney Injury After Pediatric Cardiac Surgery: a Prospective Cohort Study
The goal of this prospective cohort study is to evaluate, in pediatric patients after cardiac surgery, the predicting capability of biomarkers for acute kidney injury. The main questions it aims to answer:
- The predicting capability of acute kidney injury (AKI) biomarkers for the primary endpoint: the occurrence of AKI stage ≥ 1 within 48-h after intensive care unit (ICU) admission.
- The predicting capability of AKI biomarkers for the secondary endpoint: the occurrence of AKI stage ≥ 2 within 12-h after ICU admission.
- Investigated biomarkers include urine chitinase 3-like protein 1 (uCHI3L1), urine neutrophil gelatinase-associated lipocalin (uNGAL), tissue inhibitor of metalloproteinases-2 (TIMP-2), insulin-like growth factor-binding protein 7(IGFBP7), NephroCheck® and Δ serum creatinine [postop-preop]. Differences in concentration between patients with and without AKI development were investigated, as well as AKI diagnostic performance of (combined) biomarkers.
During and after cardiac surgery several blood and urine samples will be taken of participants to investigated AKI occurrence and to measure biomarker concentrations.
Read the detailed description
Pediatric patients after cardiac surgery were prospectively included. Urine and blood samples were taken between induction of anesthesia and the start of cardiac surgery, at intensive care unit (ICU) admission and 2, 4, 6, 12, 24, 48-h after ICU admission respectively.
Sampling was only done in the operating room and ICU. Volume and number of blood samples collected were according to the guidance of the European Commission on blood volume limits for sampling. Clinical data were extracted from the hospital records by study coordinators. Samples were anonymized as were clinical data. All technicians were blinded to clinical data.
Acute kidney injury was defined by the Kidney Disease Improving Global Outcomes (KDIGO) definition and classification, using both serum creatine as urine output criteria. AKI predicting capability of biomarkers was assessed by performing area under the receiver-operating characteristics curve (AUROC) analysis. Biomarkers were evaluated individual and as a combination of two- or three-biomarker-panels diagnostic tests. Additionally, the absolute difference between pre- and postoperative serum creatinine (ΔsCr[postop-preop]) was evaluated as diagnostic test.
To correct for urine dilution, the investigated urine biomarkers were normalized, by dividing urine biomarker concentration by urine creatinine concentration.
A sensitivity analysis was made to evaluate the biomarker performance to predict AKI ≥ 1 in patients who did not already have AKI ≥ 1 at ICU admission. Likewise, a similar sensitivity analysis was made for AKI ≥ 2.
- Conditions
- Acute Kidney Injury, Congenital Cardiac Disorders
- Keywords
- acute kidney injury, pediatric, cardiac surgery, biomarkers
- Medical subject headings
- Acute Kidney Injury, Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
AKI stage ≥ 1
occurrence of AKI stage ≥ 1 within 48 hours after ICU admission after pediatric cardiac surgery
Measured: 48 hours after ICU admission
Secondary outcomes (1)
AKI stage ≥ 2
occurrence of AKI stage ≥ 2 within 12 hours after ICU admission after pediatric cardiac surgery
Measured: 12 hours after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start1 May 2012
- Primary completion31 May 2014
- Study completion23 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Hoste, M.D.; Ph.D., Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637424
- Sponsor's protocol ID
- B670201213147
- Status last verified
- Oct 2022
- First submitted
- 17 Nov 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Section 2: AKI Definition. Kidney Int Suppl (2011). 2012 Mar;2(1):19-36. doi: 10.1038/kisup.2011.32. No abstract available.
PubMed 25018918
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential of Urine Biomarkers CHI3L1, NGAL, TIMP-2, IGFBP7 and Combinations as Complementary Diagnostic Tools for Acute Kidney Injury After Pediatric Cardiac Surgery: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05637424
- Acronym / sponsor ID
- B670201213147
- Conditions
- Acute Kidney Injury, Congenital Cardiac Disorders
- Keywords
- acute kidney injury, pediatric, cardiac surgery, biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 May 2012 (actual)
- Primary completion
- 31 May 2014 (actual)
- Study completion
- 23 Apr 2018 (actual)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this prospective cohort study is to evaluate, in pediatric patients after cardiac surgery, the predicting capability of biomarkers for acute kidney injury. The main questions it aims to answer:
- The predicting capability of acute kidney injury (AKI) biomarkers for the primary endpoint: the occurrence of AKI stage ≥ 1 within 48-h after intensive care unit (ICU) admission.
- The predicting capability of AKI biomarkers for the secondary endpoint: the occurrence of AKI stage ≥ 2 within 12-h after ICU admission.
- Investigated biomarkers include urine chitinase 3-like protein 1 (uCHI3L1), urine neutrophil gelatinase-associated lipocalin (uNGAL), tissue inhibitor of metalloproteinases-2 (TIMP-2), insulin-like growth factor-binding protein 7(IGFBP7), NephroCheck® and Δ serum creatinine [postop-preop]. Differences in concentration between patients with and without AKI development were investigated, as well as AKI diagnostic performance of (combined) biomarkers.
During and after cardiac surgery several blood and urine samples will be taken of participants to investigated AKI occurrence and to measure biomarker concentrations.
Detailed description
Pediatric patients after cardiac surgery were prospectively included. Urine and blood samples were taken between induction of anesthesia and the start of cardiac surgery, at intensive care unit (ICU) admission and 2, 4, 6, 12, 24, 48-h after ICU admission respectively.
Sampling was only done in the operating room and ICU. Volume and number of blood samples collected were according to the guidance of the European Commission on blood volume limits for sampling. Clinical data were extracted from the hospital records by study coordinators. Samples were anonymized as were clinical data. All technicians were blinded to clinical data.
Acute kidney injury was defined by the Kidney Disease Improving Global Outcomes (KDIGO) definition and classification, using both serum creatine as urine output criteria. AKI predicting capability of biomarkers was assessed by performing area under the receiver-operating characteristics curve (AUROC) analysis. Biomarkers were evaluated individual and as a combination of two- or three-biomarker-panels diagnostic tests. Additionally, the absolute difference between pre- and postoperative serum creatinine (ΔsCr[postop-preop]) was evaluated as diagnostic test.
To correct for urine dilution, the investigated urine biomarkers were normalized, by dividing urine biomarker concentration by urine creatinine concentration.
A sensitivity analysis was made to evaluate the biomarker performance to predict AKI ≥ 1 in patients who did not already have AKI ≥ 1 at ICU admission. Likewise, a similar sensitivity analysis was made for AKI ≥ 2.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Pediatric patients (age <18 years with body weight ≥ 2 kg) who underwent elective cardiac suregry, prospective enrolled preoperatively at Ghent University hospital. Exclusion criteria were AKI stage ≥1 on admission, chronic kidney disease (CKD) stage 5, kidney transplantation, surgery during weekend
Key inclusion criteria (2 listed)
- pediatric patients (age <18 years with body weight ≥ 2 kg)
- patient underwent elective cardiac surgery
Key exclusion criteria (4 listed)
- AKI stage ≥1 on admission
- chronic kidney disease (CKD) stage 5
- kidney transplantation
- cardiac surgery during weekend
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
AKI stage ≥ 1
Time frame: 48 hours after ICU admission
occurrence of AKI stage ≥ 1 within 48 hours after ICU admission after pediatric cardiac surgery
1 secondary outcome
AKI stage ≥ 2
Time frame: 12 hours after ICU admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Background: PubMed 25018918Section 2: AKI Definition. Kidney Int Suppl (2011). 2012 Mar;2(1):19-36. doi: 10.1038/kisup.2011.32. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Hoste, M.D.; Ph.D. principal investigator
University Hospital, Ghent
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Congenital Cardiac Disorders, run by University Ghent.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AKI stage ≥ 1 (time frame: 48 hours after ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05637424, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2022.