1. To assess reference values of a pre-defined set of biomarkers for AKI in *surgical* infants with normal kidney function.2. To determine the incidence of AKI in critically ill infants, according to pRIFLE criteria.3. To evaluate the sensitivity…
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. To assess reference values of a pre-defined set of biomarkers for AKI in
*surgical* infants with normal kidney function.
2. To evaluate the sensitivity and specificity of these biomarkers in
predicting AKI as well as the incidence of AKI in critically ill infants.
Secondary outcome
None
Background summary
Critically ill children are at risk of developing AKI due to insufficient
circulation. AKI has consequences for treatment. For example, dosage of drugs
that are eliminated by the kidneys needs to be adjusted to avoid accumulation,
and nephrotoxic drugs should be avoided.
The usual method to detect AKI, i.e. by serum creatinine level, provides for
relatively late detection of kidney failure only. The introduction of this
panel of biomarkers will enable earlier detection of AKI. Then, medical
treatment can be adjusted earlier.
In the current study we propose to use the following biomarkers:
Serum Cystatin C
Serum Beta-Trace-Protein
Urine Neutrophil-Gelatinase-Associated-Lipocalin
Urine Interleukin-18
Urine Kidney Injury Molecule-1
Urine Fibroblast Growth Factor-2
Urine Metalloproteinase-2
Urine Vascular Endothelial Cell Growth Factor
Urine Epidermal Growth Factor
Finally, when other biomarkers for AKI emerge, we may include these in the
analysis.
The samples will be transferred for biomarkers measurements of FGF-2, MMP-2,
VEGF and EGF to the center for Molecular Physiology Research, Division of
Nephrology, Children*s National Medical Center (CNMC), Children*s Research
Institute, Washington, District of Columbia, United States of America.
The different properties of the mentioned biomarkers emphasizes that a panel of
biomarkers may be needed to demonstrate AKI.
Study objective
1. To assess reference values of a pre-defined set of biomarkers for AKI in
*surgical* infants with normal kidney function.
2. To determine the incidence of AKI in critically ill infants, according to
pRIFLE criteria.
3. To evaluate the sensitivity and specificity of these biomarkers in
predicting AKI in critically ill infants
Study design
Prospective clinical observation trial executed in four hospitals:
ErasmusMC - Sophia Children's Hospital Rotterdam
UMC St. Radboud Nijmegen
Albert Schweitzer Ziekenhuis Dordrecht
Sint Fransiscus Gasthuis Rotterdam
Study burden and risks
The risks and burdens associated with this study are negligible. Blood samples
are taken from an indwelling catheter already in place for clinical purposes or
by a capillary punction which is considered to be a minimal invasive procedure.
Urine samples will be collected by using a urine catheter or ) or by a gauze in
the patient*s diaper from which urine will be extracted. Bladder catherization
is part of standard care in case of ECMO treatment or treatment of critically
ill children.
Dr. Molewaterplein 60
3015 GJ Rotterdam
NL
Dr. Molewaterplein 60
3015 GJ Rotterdam
NL
Listed location countries
Age
Inclusion criteria
- Age: Up to 12 months
- Group 1: - Patients admitted for minor surgical procedures with stable hemodynamics and normal kidney function: term up to 1 year of age
- Group 2: - Critical illness: mechanical ventilation
- Need for vasopressor drugs
- Group 3: - Critically ill patients with ECMO treatment
- Group 4: - Neonates admitted for minor surgical procedures with stable hemodynamics and normal kidney function: 32 up to 37 weeks of gestational age
Exclusion criteria
- No informed consent
- Pre-existent kidney disease or kidney anomaly on ultrasound
- Group 1 and 4: Use of known nephrotoxic drugs, like aminoglycosides
pRIFLE score showing AKI
- Group 1, 2, 3: Preterm birth
- Group 4: Preterm birth before 32 weeks of gestational age
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL30981.078.10 |