Trial reportClinical pharmacokinetics2021
Glomerular Filtration Rate in Asphyxiated Neonates Under Therapeutic Whole-Body Hypothermia, Quantified by Mannitol Clearance.
Trial report in Clinical pharmacokinetics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03162653 (Effect of ALlopurinol in Addition to Hypothermia for Hypoxic-ischemic Brain Injury on Neurocognitive Outcome - a Blinded Randomized Placebo-controlled Parallel Group Multicenter Trial for Superiority), which is not on this map. Cited by 11 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Effect of ALlopurinol in Addition to Hypothermia for Hypoxic-ischemic Brain Injury on Neurocognitive Outcome - a Blinded Randomized Placebo-controlled Parallel Group Multicenter Trial for Superiority (Phase III)
Who cites it
11 citing papers in PubMed, 13 citations in OpenAlex.
- Progression of the estimated glomerular filtration rate in asphyxiated neonates undergoing therapeutic hypothermia during the first 10 days of life.Pediatric nephrology (Berlin, Germany) · 2026Article
- Time-dependent pattern of liver injury biomarkers in neonates with hypoxic-ischemic encephalopathy undergoing therapeutic hypothermia.European journal of pediatrics · 2026Article
- Clearance of mannitol for assessment of glomerular filtration rate in chronic kidney disease: A validation against iohexol clearance.Clinical physiology and functional imaging · 2026Article
- Pharmacological Therapies for Consequences of Perinatal Hypoxic-Ischemic Brain Injury: Where Are We Now?International journal of molecular sciences · 2025Review
- Intraoperative lactate level correlated with the length of hospital stay in patients with intraoperative hypothermia.Medicine · 2025Observational
- From Fragmented Data to Integrated Drug Development in Asphyxiated Neonates Undergoing Therapeutic Hypothermia.Journal of clinical pharmacology · 2025Article
- Machine learning based clinical decision tool to predict acute kidney injury and survival in therapeutic hypothermia treated neonates.Scientific reports · 2025Article
- A Population Model of Time-Dependent Changes in Serum Creatinine in (Near)term Neonates with Hypoxic-Ischemic Encephalopathy During and After Therapeutic Hypothermia.The AAPS journal · 2023Article
- Semi-mechanistic Modeling of Hypoxanthine, Xanthine, and Uric Acid Metabolism in Asphyxiated Neonates.Clinical pharmacokinetics · 2022Article
- A single dose of aminophylline administration during therapeutic hypothermia; does it make a difference in glomerular filtration rate?European journal of pediatrics · 2021Article
- Creatinine Trends and Patterns in Neonates Undergoing Whole Body Hypothermia: A Systematic Review.Children (Basel, Switzerland) · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 8 institutions in 3 countries.
Funding
Abstract
backgroundTherapeutic hypothermia (TH) is an established intervention to improve the outcome of neonates with moderate-to-severe hypoxic-ischemic encephalopathy resulting from perinatal asphyxia. Despite this beneficial effect, TH may further affect drug elimination pathways such as the glomerular filtration rate.
objectivesThe objective of this study was to quantify the effect of TH in addition to asphyxia on mannitol clearance as a surrogate for the glomerular filtration rate.
methodsThe effect of asphyxia and TH (mild vs moderate/severe) on mannitol clearance was assessed using a population approach, based on mannitol observations collected in the ALBINO (ALlopurinol in addition to TH for hypoxic-ischemic Brain Injury on Neurocognitive Outcome) trial, as some were exposed to a second dose of 10 mg/kg intravenous mannitol as placebo to ensure blinding. Pharmacokinetic analysis and model development were conducted using NONMEM version 7.4.
resultsBased on 77 observations from 17 neonates (TH = 13), a one-compartment model with first-order linear elimination best described the observed data. To account for prenatal glomerular filtration rate maturation, both birthweight and gestational age were implemented as clearance covariates using an earlier published three-quarters power function and a sigmoid hyperbolic function. Our final model predicted a mannitol clearance of 0.15 L/h for a typical asphyxia neonate (39.5 weeks, birthweight 3.25 kg, no TH), lower than the reported value of 0.33 L/h for a healthy neonate of similar age and weight. By introducing TH as a binary covariate on clearance, the additional impact of TH on mannitol clearance was quantified (60% decrease).
conclusionsMannitol clearance was decreased by approximately 60% in neonates undergoing TH, although this is likely confounded with asphyxia severity.
trial registrationClinicalTrials.gov identifier NCT03162653.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.