Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04008810 |
| Other study ID # |
H-19003424 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 3, 2019 |
| Est. completion date |
January 18, 2024 |
Study information
| Verified date |
February 2023 |
| Source |
Hillerod Hospital, Denmark |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Acute kidney injury (AKI) is associated with significant morbidity and mortality, and because
no specific treatment is available, early acknowledgment is needed. The incidence of AKI and
chronic kidney disease (CKD) have been increasing over time but it is not until the past
decade there is an understanding of a bidirectional nature between AKI and CKD, where AKI
predisposes to CKD and vice versa. The criteria for diagnosing AKI is through serum
creatinine (sCr) and/or urine output. As detection of sCr-increases are delayed by 48-72
hours it is not an optimal biomarker for early recognition of AKI. In contrast the biomarker
neutrophil gelatinase-associated lipocalin (NGAL) has shown to predict AKI within 12h of
critical disease or postoperative, and without the requirement of prior measurements for
comparison.
The purpose of the project is to investigate if the relatively new biomarker NGAL (neutrophil
gelatinase-associated lipocalin), which is known to be able to detect AKI in an early phase,
can be used to detect development of CKD and potential future hospital admissions in a
relatively large and diverse cohort of patients admitted to the Acute Emergency Department at
North Zealand Hospital.
The study is designed as a longitudinal prospective study where there is an enrollment
estimation of 3600 unselected patients over one year. Blood tests will be taken when admitted
and thereafter every day for the first week and subsequently every once a week throughout
hospitalization. Patients that are sent home the same day, will still be included in the
study but without further NGAL analyses.
Description:
Acute kidney injury (AKI) is associated with significant morbidity and mortality, and because
no specific treatment is available, early acknowledgment is needed. The incidence of AKI and
chronic kidney disease (CKD) have been increasing over time but it is not until the past
decade there is an understanding of a bidirectional nature between AKI and CKD, where AKI
predisposes to CKD and vice versa. The criteria for diagnosing AKI is through serum
creatinine (sCr) and/or urine output. As detection of sCr-increases are delayed by 48-72
hours it is not an optimal biomarker for early recognition of AKI. In contrast the biomarker
neutrophil gelatinase-associated lipocalin (NGAL) has shown to predict AKI within 12h of
critical disease or postoperative, and without the requirement of prior measurements for
comparison.
The purpose of the project is to investigate if the relatively new biomarker NGAL (neutrophil
gelatinase-associated lipocalin), which is known to be able to detect AKI in an early phase,
can be used to detect development of CKD and potential future hospital admissions in a
relatively large and diverse cohort of patients admitted to the Acute Emergency Department at
North Zealand Hospital.
The study is designed as a longitudinal prospective study where there is an enrollment
estimation of 3600 unselected patients over one year. Blood tests will be taken when admitted
and thereafter every day for the first week and subsequently every once a week throughout
hospitalization. Patients that are sent home the same day, will still be included in the
study but without further NGAL analyses. There will be follow-up time in all patients
included in the study, up to one year after admission through the Danish National Patient
Register and medical journals to see if the patients are reinstated, what they are diagnosed
with and if they have had other hospital contacts. This will further be done to examine if
NGAL is better at predicting the number of hospital contacts, up to one year after discharge.
Primary endpoint:
If NGAL can predict development of CKD defined as eGFR < 60ml/min per 1.73 m^2 and/or
albumin/creatinine ratio >= 30mg/g over 3 months in patients upfilling the AKI criteria with
a delta-creatinine >= 26,5 umol/l during the initial hospital admission, within one year from
first admission. Cystatin C values will be compared to NGAL.
Secondary endpoints:
- The risk assessments (risk factor and risk patients) described by The Danish Society of
Nephrology will be operationalized and interpreted. The data will be collected from
medical records, Danish National Patient Registry (DNPR) and Danish Register of Causes
of Death (DRCD) in patients with AKI.
- Patients meeting >= 1 of the either "risk factors" or "risk patients" in risk of
developing AKI and with a delta-creatinine >=26,5 l mol/L and/or an sCr increase by 50%
in seven days during the primary hospital stay, will be compared with NGAL and
information from medical records, hospital discharge diagnosis, DNPR and DRCD.
