Acute Kidney InjuryHERONCT03946345
Iohexol for Measuring Renal Function
An observational study of Acute Kidney Injury and Critically Ill Children, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Approximately 25-35% of all children admitted to the paediatric intensive care unit (PICU) or neonatal intensive care unit (NICU) will develop Acute Kidney Injury (AKI) during the first seven days after admission. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Acute Kidney Injury, Critically Ill Children
- What is being tested?
- Iohexol Inj 300 MG/ML
- Type of treatment
- Injection or infusion
- How many people
- 105 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2019to 30 Apr 2021
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 105 critically ill children admitted to the pediatric intensive care unit or neonatal intensive care unit from the Radboudumc with at least one failing organ.
Who may be able to join
- 0-18 years of postnatal age
- >37 weeks of gestational age (for infants < one year postnatal age)
- Bodyweight >2500g
- Patients admitted to pediatric or neonatal intensive care unit
- PELOD-II (pediatric logistic organ dysfunction score, 2nd version) of 1 or higher (= at least one failing organ)
- Indwelling central line or arterial line in place for clinical purposes, or scheduled regular blood work for clinical reasons (at least once a day)
- Informed written consent
Who cannot join
- Known medical history of allergic reaction to injection of iodinated contrast material
- Receiving renal replacement therapy
- Language or cognitive inability of parents/caregivers to understand written and oral informed consent.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboudumc
Nijmegen, 6525 GA
Nori JL Smeets, MD, 0031-24-3614214, nori.smeets@radboudumc.nl
About this study
Approximately 25-35% of all children admitted to the paediatric intensive care unit (PICU) or neonatal intensive care unit (NICU) will develop Acute Kidney Injury (AKI) during the first seven days after admission. AKI is associated with a worse outcome, including an increased risk of mortality compared to patients without AKI. However, this AKI prevalence estimation is based on serum creatinine based glomerular filtration rate (eGFR), which is known to be inaccurate. The investigators postulate that measured GFR (mGFR) based on iohexol clearance in critically ill children will detect a higher prevalence of children with AKI than currently used methods based on endogenous markers. This study will additionally provide mechanistic knowledge on the relative contribution of GFR and renal transport to renal function in critically ill children.
Read the detailed description
Primary objective: To determine the prevalence of AKI in critically ill children based on clearance of iohexol.
Secondary objectives:
- To determine the prevalence of AKI in critically ill children using serum creatinine, creatinine clearance, cystatin C and/or blood urea nitrogen based eGFR equations as well as urinary iohexol clearances.
- To determine serum Proenkephalin (PENK) levels in critically ill children.
- To compare the prevalence of AKI when this diagnosis is based on plasma iohexol clearances with the prevalence of AKI based on serum creatinine, creatinine clearance, serum cystatin C, PENK and/or Blood Urea Nitrogen (BUN) based eGFR and to assess agreement between those methods
- To determine risk factors for the development of AKI when based on iohexol clearance.
Exploratory endpoint: To explore the relationship of genetic variation with the development of AKI.
- Conditions
- Acute Kidney Injury, Critically Ill Children
- Being tested
- Iohexol Inj 300 MG/ML
- Keywords
- Iohexol, Glomerular Filtration Rate
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iohexol Inj 300 MG/MLDrug
Also called OMNIPAQUE 300
- Administration of iohexol: each 24 hours one bolus IV (1-5ml) during 72 hours
- Blood samples are drawn for analysis of iohexol concentrations and other parameters of renal function at 2, 5 and 7 hours after administration
- Urine is collected from catheter between 4 and 6 hours after adminstration to determine urine creatinine and iohexol concentrations
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of AKI in critically ill children based on iohexol plasma clearance
AKI will be defined by using age-specific reference values of GFR. Based on their standard deviations (SD), three groups are defined:
- Stage 1: mean -1 SD > GFR < mean -1.5 SD
- Stage 2: mean -1.5 SD> GFR < mean -2 SD
- Stage 3: GFR < mean -2 SD
Patients will be grouped according whether they lack AKI or have AKI (either stage 1, 2 or 3). When a patient will be classified as having AKI at one moment and not fulfilling the AKI-criteria at another, or classified into different stages of AKI within one day, the highest stage of the 72 hours will be used for analysis.
Measured: 72 hours
Secondary outcomes (8)
Prevalence of AKI using serum creatinine, creatinine clearance, urinary iohexol, serum cystatin C, serum PENK and/or blood urea nitrogen based eGFR equations.
Classification of AKI based on serum creatinine levels:
- Stage 1: serum creatinine concentration >150% of median age specific reference value.
- Stage 2: serum creatinine concentration >200% of median age specific reference value.
- Stage 3: serum creatinine concentration >300% of median age specific reference value.
Creatinine clearance: CrCl(ml/min/1.73m2) = (urine volume × urine creatinine × 1.73)/ (serum creatinine × 120 minutes × body surface area)
AKI classification based on serum cystatin C levels will be similar to classification based on serum creatinine levels
Urinary iohexol clearance: Ku(X)(t)=dXu/dt \& Cl(u)=dXudt/AUCpdt
AKI will be classified based on eGFR calculated by the CKiD Schwartz Equation
Data will be analysed for the overall 72 hour period, using the highest grade of AKI during the study duration, as well as per 24 hour period.
Measured: 72 hours
Serum PENK levels, in relation to iohexol based GFR-measurements in critically ill children.
Measured: 72 hours
Agreement between diagnosis of AKI when based on iohexol clearance compared to diagnosis based on serum creatinine levels
Measured: 72 hours
Agreement between diagnosis of AKI when based on iohexol clearance compared to diagnosis based on creatinine clearance
Measured: 72 hours
Agreement between diagnosis of AKI when based on iohexol clearance compared to diagnosis based on serum cystatin C levels
Measured: 72 hours
Agreement between diagnosis of AKI when based on iohexol clearance compared to diagnosis based on serum PENK levels
Measured: 72 hours
Agreement between diagnosis of AKI when based on iohexol clearance compared to diagnosis based on CKiD Schwartz Equation (Serum Creatinine, BUN and Cytatin C)
Measured: 72 hours
Risk factors for the development of AKI when based on iohexol clearance.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start1 May 2019
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- 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
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saskia N De Wildt, MD PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946345
- Sponsor's protocol ID
- NL68547.091.18
- Acronym
- HERO
- Status last verified
- May 2019
- First submitted
- 3 May 2019
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iohexol for Measuring Renal Function
- ClinicalTrials.gov ID
- NCT03946345
- Acronym / sponsor ID
- HERO / NL68547.091.18
- Conditions
- Acute Kidney Injury, Critically Ill Children
- Keywords
- Iohexol, Glomerular Filtration Rate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 10 May 2019 (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.
Approximately 25-35% of all children admitted to the paediatric intensive care unit (PICU) or neonatal intensive care unit (NICU) will develop Acute Kidney Injury (AKI) during the first seven days after admission. AKI is associated with a worse outcome, including an increased risk of mortality compared to patients without AKI. However, this AKI prevalence estimation is based on serum creatinine based glomerular filtration rate (eGFR), which is known to be inaccurate. The investigators postulate that measured GFR (mGFR) based on iohexol clearance in critically ill children will detect a higher prevalence of children with AKI than currently used methods based on endogenous markers. This study will additionally provide mechanistic knowledge on the relative contribution of GFR and renal transport to renal function in critically ill children.
Detailed description
Primary objective: To determine the prevalence of AKI in critically ill children based on clearance of iohexol.
Secondary objectives:
- To determine the prevalence of AKI in critically ill children using serum creatinine, creatinine clearance, cystatin C and/or blood urea nitrogen based eGFR equations as well as urinary iohexol clearances.
- To determine serum Proenkephalin (PENK) levels in critically ill children.
- To compare the prevalence of AKI when this diagnosis is based on plasma iohexol clearances with the prevalence of AKI based on serum creatinine, creatinine clearance, serum cystatin C, PENK and/or Blood Urea Nitrogen (BUN) based eGFR and to assess agreement between those methods
- To determine risk factors for the development of AKI when based on iohexol clearance.
Exploratory endpoint: To explore the relationship of genetic variation with the development of AKI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 105 critically ill children admitted to the pediatric intensive care unit or neonatal intensive care unit from the Radboudumc with at least one failing organ.
Key inclusion criteria (7 listed)
- 0-18 years of postnatal age
- >37 weeks of gestational age (for infants < one year postnatal age)
- Bodyweight >2500g
- Patients admitted to pediatric or neonatal intensive care unit
- PELOD-II (pediatric logistic organ dysfunction score, 2nd version) of 1 or higher (= at least one failing organ)
Key exclusion criteria (3 listed)
- Known medical history of allergic reaction to injection of iodinated contrast material
- Receiving renal replacement therapy
- Language or cognitive inability of parents/caregivers to understand written and oral informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iohexol Inj 300 MG/MLAlso: OMNIPAQUE 300* Administration of iohexol: each 24 hours one bolus IV (1-5ml) during 72 hours * Blood samples are drawn for analysis of iohexol concentrations and other parameters of renal function at 2, 5 and 7 hours after administration * Urine is collected from catheter between 4 and 6 hours after adminstration to determine urine creatinine and iohexol concentrations | Drug | – |
Primary outcome
Prevalence of AKI in critically ill children based on iohexol plasma clearance
Time frame: 72 hours
AKI will be defined by using age-specific reference values of GFR. Based on their standard deviations (SD), three groups are defined: * Stage 1: mean -1 SD > GFR < mean -1.5 SD * Stage 2: mean -1.5 SD> GFR < mean -2 SD * Stage 3: GFR < mean -2 SD Patients will be grouped according whether they lack AKI or have AKI (either stage 1, 2 or 3). When a patient will be classified as having AKI at one moment and not fulfilling the AKI-criteria at another, or classified into different stages of AKI within one day, the highest stage of the 72 hours will be used for analysis.
8 secondary outcomes
Prevalence of AKI using serum creatinine, creatinine clearance, urinary iohexol, serum cystatin C, serum PENK and/or blood urea nitrogen based eGFR equations.
Time frame: 72 hours
Serum PENK levels, in relation to iohexol based GFR-measurements in critically ill children.
Time frame: 72 hours
Agreement between diagnosis of AKI when based on iohexol clearance compared to diagnosis based on serum creatinine levels
Time frame: 72 hours
Agreement between diagnosis of AKI when based on iohexol clearance compared to diagnosis based on creatinine clearance
Time frame: 72 hours
Agreement between diagnosis of AKI when based on iohexol clearance compared to diagnosis based on serum cystatin C levels
Time frame: 72 hours
Agreement between diagnosis of AKI when based on iohexol clearance compared to diagnosis based on serum PENK levels
Time frame: 72 hours
Agreement between diagnosis of AKI when based on iohexol clearance compared to diagnosis based on CKiD Schwartz Equation (Serum Creatinine, BUN and Cytatin C)
Time frame: 72 hours
Risk factors for the development of AKI when based on iohexol clearance.
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- 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.
Saskia N De Wildt, MD PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Critically Ill Children, run by Radboud University Medical Center at 1 site in Netherlands.
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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nori JL Smeets, MD (0031-24-3614214, nori.smeets@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of AKI in critically ill children based on iohexol plasma clearance (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2019.