I-KID study protocol: evaluation of efficacy, outcomes and safety of a new infant haemodialysis and ultrafiltration machine in clinical use: a randomised clinical investigation using a cluster stepped-wedge design

Lambert, H; Sharma, Shriya; Matthews, J. N. S.

doi:10.1136/bmjpo-2021-001224

Cited by 9 publications

(15 citation statements)

References 24 publications

(33 reference statements)

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“…First, the patient can be weighed before and after a dialysis treatment; we have reported that the NIDUS was very precise during 4-h clinical dialysis sessions in 6 kg babies, while a conventional Gambro AK200 pediatric dialyzer caused large fluid shifts that produced hypotension which needed urgent therapy [ 4 ]. A second approach is to weigh the dialysate, replacement and waste fluid bags before and after a dialysis session to determine the quantity of fluid added due to UF from the baby—this is the technique used in the IKID study [ 5 ]. The third, and simplest, approach is to do an in vitro study of the change in weight of a saline bag during ‘treatment’ as we have done here.…”

Section: Discussionmentioning

confidence: 99%

“…Currently in the UK, most babies weighing < 8 kg who undergo HT are treated off-license with continuous veno-venous hemofiltration (CVVH) using either the Prismaflex or the Aquarius devices, or the novel Newcastle infant hemodialysis and ultrafiltration system (NIDUS) for those in the IKID (Infant Kidney Dialysis and filtration) study. The IKID study is funded by the Efficiency and Mechanism Evaluation programme of the National Institute for Health Research, is designed to compare current practice including peritoneal dialysis with NIDUS [ 5 ] and has completed recruitment and will be reporting shortly. The NIDUS has been designed to treat babies of between 800 g and 8 kg and uses a volumetrically controlled syringe-driven circuit to regulate fluid balance, rather than using circuit pressures to regulate the UF control algorithms as occurs in conventional HT devices.…”

Section: Introductionmentioning

confidence: 99%

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In vitro measurements of ultrafiltration precision in hemofiltration and hemodialysis devices used in infants

et al. 2022

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Background To determine in vitro whether infant hemofiltration and hemodialysis devices can reliably deliver precise ultrafiltration (UF) control. Methods We tested the Prismaflex, Aquarius and NIDUS devices which have different circuit types, by in vitro testing with a bag of saline set up as a dummy patient, and monitoring fluid shifts by precise weighing. We looked for differences between the UF rates set and achieved and between the UF result the device displays to the clinician and the true volumes removed, which may lead to clinical errors. We performed short studies at UF settings of zero and 40 ml/h, and with and without simulating poor withdrawal and return lines, and simulated a 4-h treatment session. Results The Prismaflex setting vs actual errors and display vs actual errors had wide variances, with SDs of 4.1 and 14.0 ml by 15 min, respectively, at both zero and 40 ml/h UF settings. The Aquarius values were wider at 17.3 and 30.3 ml, respectively. For the NIDUS, the mean UF errors were close to zero, and the variances were 0.17 ml. Stop-alarms induced by an obstructed line produced extra UF errors of up to 0.2 ml. A limitation was that we used crystalloid and not colloid for these tests. Conclusions Hemotherapy devices with conventional circuits available in the UK do not regulate UF control sufficiently well to recommend for use in small infants, but the NIDUS volumetrically controlled circuit does. All hemotherapy devices intended for small infants should be tested for UF precision. We were unable to test the CARPEDIEM or Aquadex devices. Graphical Abstract A higher resolution version of the Graphical abstract is available as Supplementary information

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

In vitro measurements of ultrafiltration precision in hemofiltration and hemodialysis devices used in infants

et al. 2022

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“…A dedicated neonatal or infant dialysis machine, CARPEDIEM, was introduced in clinical practice, while another machine, NIDUS, is currently under investigation. 28 , 29 , 30 , 31 However, only 15% of PICUs described availability of one of these dedicated neonatal or infant machines. Nonetheless, it should be highlighted that third- and fourth-generation machines have repeatedly been shown to have a high level of accuracy in children, and dedicated technology should be strongly recommended in children weighing less than 8 to 10 kg, especially because of smaller priming volumes and accurate ultrafiltration rates.…”

Section: Discussionmentioning

confidence: 99%

“…In case of insufficient desired toxin clearance, respondents preferred to change the CKRT modality, followed by increasing the effluent rate (eFigure 3B in Supplement 1). The CKRT dose was calculated mainly (72%) using a weight-based formula (mL/kg/h), and the median (IQR) CKRT dose among the PICUs was 35 (30-50) mL/kg/h in neonates and 30 (30)(31)(32)(33)(34)(35)(36)(37)(38)(39)(40)…”

Section: Ckrt Initiation and Terminationmentioning

confidence: 99%

“…More than one-third (39%) of the PICUs used diuretics while the patient was receiving CKRT, and more than half (60%) of the PICUs altered the prescription of nutritional support mainly by changing the amount of protein (48%) and calories (38%) (Table2).In case of insufficient desired toxin clearance, respondents preferred to change the CKRT modality, followed by increasing the effluent rate (eFigure 3B in Supplement 1). The CKRT dose was calculated mainly (72%) using a weight-based formula (mL/kg/h), and the median (IQR) CKRT dose among the PICUs was 35 (30-50) mL/kg/h in neonates and 30(30)(31)(32)(33)(34)(35)(36)(37)(38)(39)(40) mL/kg/h in children aged 1 month to 18 years. Only 30% of PICUs reported ever using a CKRT dose over 40 mL/kg/h, with a median (IQR) dose of 80 (45-120) mL/kg/h.…”

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confidence: 99%

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Continuous Kidney Replacement Therapy Practices in Pediatric Intensive Care Units Across Europe

et al. 2022

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ImportanceContinuous kidney replacement therapy (CKRT) is the preferred method of kidney support for children with critical illness in pediatric intensive care units (PICUs). However, there are no data on the current CKRT management practices in European PICUs.ObjectiveTo describe current CKRT practices across European PICUs.Design, Setting, and ParticipantsThis cross-sectional survey of PICUs in 20 European countries was conducted by the Critical Care Nephrology Section of the European Society of Pediatric and Neonatal Intensive Care from April 1, 2020, to May 31, 2022. Participants included intensivists and nurses working in European PICUs. The survey was developed in English and distributed using SurveyMonkey. One response from each PICU that provided CKRT was included in the analysis. Data were analyzed from June 1 to June 30, 2022.Main Outcome and MeasuresDemographic characteristics of European PICUs along with organizational and delivery aspects of CKRT (including prescription, liberation from CKRT, and training and education) were assessed.ResultsOf 283 survey responses received, 161 were included in the analysis (response rate, 76%). The attending PICU consultant (70%) and the PICU team (77%) were mainly responsible for CKRT prescription, whereas the PICU nurses were responsible for circuit setup (49%) and bedside machine running (67%). Sixty-one percent of permanent nurses received training to use CKRT, with no need for certification or recertification in 36% of PICUs. Continuous venovenous hemodiafiltration was the preferred dialytic modality (51%). Circuit priming was performed with normal saline (67%) and blood priming in children weighing less than 10 kg (56%). Median (IQR) CKRT dose was 35 (30-50) mL/kg/h in neonates and 30 (30-40) mL/kg/h in children aged 1 month to 18 years. Forty-one percent of PICUs used regional unfractionated heparin infusion, whereas 35% used citrate-based regional anticoagulation. Filters were changed for filter clotting (53%) and increased transmembrane pressure (47%). For routine circuit changes, 72 hours was the cutoff in 62% of PICUs. Some PICUs (34%) monitored fluid removal goals every 4 hours, with variation from 12 hours (17%) to 24 hours (13%). Fluid removal goals ranged from 1 to 3 mL/kg/h. Liberation from CKRT was performed with a diuretic bolus followed by an infusion (32%) or a diuretic bolus alone (19%).Conclusions and RelevanceThis survey study found a wide variation in current CKRT practice, including organizational aspects, education and training, prescription, and liberation from CKRT, in European PICUs. This finding calls for concerted efforts on the part of the pediatric critical care and nephrology communities to streamline CKRT education and training, research, and guidelines to reduce variation in practice.

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Neonatal Kidney Dysfunction

Guzzo

Picca²,

Askenazi³

2023

Pediatric Kidney Disease

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I-KID study protocol: evaluation of efficacy, outcomes and safety of a new infant haemodialysis and ultrafiltration machine in clinical use: a randomised clinical investigation using a cluster stepped-wedge design

Cited by 9 publications

References 24 publications

In vitro measurements of ultrafiltration precision in hemofiltration and hemodialysis devices used in infants

In vitro measurements of ultrafiltration precision in hemofiltration and hemodialysis devices used in infants

Continuous Kidney Replacement Therapy Practices in Pediatric Intensive Care Units Across Europe

Neonatal Kidney Dysfunction

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