Renal Function Assessment in Critically Ill Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-20

Study Completion Date

2021-02-07

Brief Summary

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Identification of renal dysfunction in critically ill children is often delayed due to lack of accurate methods for evaluation of glomerular filtration rate (GFR). The investigators compared GFR measurement by the gold standard technique iohexol plasma clearance with estimated GFR (eGFR) based on selected established formulas incorporating the renal biomarkers creatinine, cystatin C and betatrace protein.

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Detailed Description

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Acute kidney injury (AKI) is a frequent comorbidity of critical illness associated with poor outcome, including prolonged duration of mechanical ventilation, longer length of stay and increased mortality or progression to chronic kidney disease on the long term. The reported incidence of AKI in critically ill children and neonates varies widely between 10% and 80% depending on the diagnostic criteria. Besides a decline in renal function, also the phenomenon of augmented renal clearance (ARC) and in consequence enhanced clearance of renally eliminated drugs, is increasingly recognized in pediatric intensive care patients. Hence, accurate assessment of renal function is crucial in the intensive care population to guide therapy. But to date consensus is lacking about the reliability of common GFR estimation methods based on the endogenous renal biomarkers serum creatinine, cystatin C and betatrace protein in critical care patients. the aim of this study is to measure GFR in a reliable way by iohexol plasma clearance and evaluate the agreement between the gold standard technique iohexol plasma clearance and biomarker-based formula to estimate GFR.

Conditions

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Iohexol Pharmacokinetics Renal Function Critically Ill Children Acute Kidney Injury Augmented Renal Clearance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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iohexol plasma clearance

a weight-dependent dose of iohexol will be injected as an intravenous bolus in 100 patients

2,5 -9kg = 1ml; 10-19kg = 2ml; 20-29kg = 3ml; 30-39kg = 4ml; ≥ 40kg = 5ml

Group Type EXPERIMENTAL

iohexol administration

Intervention Type DIAGNOSTIC_TEST

IV injection of weight-dependent low dose of iohexol at time 0

iohexol blood sampling

Intervention Type DIAGNOSTIC_TEST

Blood sampling will be performed through an arterial (preferred) or venous line, other than the iohexol infusion line. In the first 30 minutes after iohexol injection, a blood sample of 2 ml will be obtained for iohexol concentration measurement and determination of renal biomarkers serum creatinine, cystatin C, betatrace protein. Subsequently, 2 up to 5 additional blood samples of 0,5 ml will be obtained for iohexol determination at 60,120 ,180, 240 and 360 minutes after iohexol injection to calculate iohexol plasma clearance from the plasma disappearance curve

Interventions

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iohexol administration

IV injection of weight-dependent low dose of iohexol at time 0

Intervention Type DIAGNOSTIC_TEST

iohexol blood sampling

Blood sampling will be performed through an arterial (preferred) or venous line, other than the iohexol infusion line. In the first 30 minutes after iohexol injection, a blood sample of 2 ml will be obtained for iohexol concentration measurement and determination of renal biomarkers serum creatinine, cystatin C, betatrace protein. Subsequently, 2 up to 5 additional blood samples of 0,5 ml will be obtained for iohexol determination at 60,120 ,180, 240 and 360 minutes after iohexol injection to calculate iohexol plasma clearance from the plasma disappearance curve

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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omnipaque

Eligibility Criteria

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Inclusion Criteria

* patients admitted to the pediatric or neonatal intensive care unit
* 0 - 15 years
* for neonates: gestational age ≥ 37 weeks
* bodyweight \>2.5kg
* intra-arterial and/or intravenous access available for iohexol administration and blood sampling

Exclusion Criteria

* no vascular access in place for iohexol administration and blood sampling
* absence of parental/patient consent
* known hypersensitivity to contrast media or previous history of adverse reaction after administration of contrast agents
* known thyroid dysfunction, or for newborns: mother with known thyroid dysfunction
* extracorporeal circuit (haemodialysis, extra corporal membrane oxygenation (ECMO), peritoneal dialysis)
* patients with chronic kidney disease or congenital kidney anomalies
* preterm neonates (gestational age \< 37 weeks)
* body weight \< 2.5 kg
* dehydrated newborns (i.e. loss of birth weight ≥ 10%)
* planned/expected surgery with extracorporeal circulation within 5 days after inclusion

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No