Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Assessing Cognitive fUnction and MEasuring the Cerebral circulatioN on HaemoDialysis (ACUMEN-HD)

18 mars 2015 mis à jour par: NHS Greater Glasgow and Clyde

Exploring the Natural History of Cerebrovascular Disease in Patients With End-stage Renal Disease on Haemodialysis

Stroke disease and cognitive impairment are common in patients established on haemodialysis (HD) for end-stage renal disease (ESRD). Further, initiation of HD appears to transiently increase the risk of stroke. The mechanism by which this occurs is not known.

Using ultrasound, patient questionnaires and brain MRI our study will observe changes in cognition and cerebral blood flow whilst receiving HD compared to a non-dialysis day. Transient clinical and ultrasound alterations will be correlated to radiographic changes in cerebral perfusion and structure on MRI to determine the underlying mechanism for the increased stroke risk. The investigators will observe this effect in the immediate and longer term (12 months observation).

A greater understanding will allow development of effective preventive strategies.

Aperçu de l'étude

Description détaillée

Stroke is common in the United Kingdom and a leading cause of adult disability. It has been reported that more than half of all stroke survivors remain dependent on carers for everyday activities. A greater understanding stroke disease has led to improvements in stroke care for the general population.

Patients with ESRD are at increased risk of cerebrovascular disease with a risk approximately 5-10 times higher than the general population yet a relative paucity of data exploring the mechanisms and impact of stroke disease on patients on HD remains. Signs of cerebrovascular disease are common with evidence of early stroke disease (white matter hyperintensities on MRI) having been described in up to 50% of ESRD patients. In addition to this it is now estimated that up to 70% of patients on dialysis aged 55 years and older have moderate to severe cognitive impairment. Previous work has revealed that cognition declines during dialysis - specifically a decrease in executive function has been reported, without significant memory impairment. Such findings are in suggestive of vascular related injury. Mean cerebral blood flow assessed by transcranial Doppler ultrasound is reduced during dialysis, although whether this finding is associated with a clinical outcome is not clear.

In order to generate appropriate preventive strategies for stroke in ESRD the mechanism by which injury occurs must be confirmed. In addition, although a decrease in executive function has been shown during HD it is unclear if long-term HD is associated with progressive decline or if this clinical finding correlates with neuroimaging.

This study is being performed to determine:

  • The impact of long term HD (including indices of cardiovascular instability) on changes on brain MRI and cognitive function.
  • The relationship between intracerebral blood flow rate, brain MRI findings and neurocognitive function
  • The relationship between intracranial blood flow measures (during and post haemodialysis (HD)) and brain perfusion and structure

Following informed written consent patients will be observed over a 12 month period. On the first visit participants will undergo a transcranial ultrasound before and during HD to achieve baseline and intra-dialytic blood flow velocities. During the dialysis sessions a neurocognitive assessment (patient questionnaire) will be performed which will assess multiple cognitive domains. On completion of dialysis a subgroup will undergo a brain MRI. All patients will meet with the investigators within 2 weeks to repeat the neurocognitive assessment on a non-dialysis day. This will allow for comparison of cognitive changes, alterations in cerebral blood flow and (in some) correlation with MRI findings. All participants will repeat this process 12 months later.

Type d'étude

Observationnel

Inscription (Anticipé)

97

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 85 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

All adult patients receiving haemodialysis for end-stage renal disease.

La description

Inclusion Criteria:

  • Adult patients treated with HD at the Glasgow Renal Unit and its satellite units

Exclusion Criteria:

  • Planned live donor transplant is planned during the next 6 months
  • Predicted life expectancy <6 months
  • Inability to give informed consent
  • Contraindications to MRI imaging (pacemaker, extreme claustrophobia),
  • Known clinical or radiological diagnoses of cerebrovascular disease
  • Severe cognitive impairment (MOCA <17)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Patients with ESRD on HD
Adult patients with ESRD on HD. Observing the effect of a single HD session on cerebral blood flow (assessed by transcranial doppler) and cognitive function (assessed by neurocognitive questionnaires). Subgroup to undergo brain MRI.
Observing effect of routine HD via transcranial doppler, neurocognitive questionnaires and (in some) brain MRI

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Progression of white matter hyperintensities on MRI
Délai: 12 months
Use of visual rating scales to quantify white matter burden at time 0 and 12 months
12 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Correlation between alterations in cerebral blood flow and cognition
Délai: Within 4 hour treatment period (of HD)
Statistical correlation determined between a decreased in cerebral blood flow (as measured on transcranial doppler) and reduction in cognitive scores on assessment
Within 4 hour treatment period (of HD)
Correlation between alterations in cerebral blood flow and white matter hyperintensity burden progression
Délai: 12 months
Statistical correlation between reductions in cerebral bloe
12 months
Evidence of transient cognitive impairment during HD
Délai: Within 2 weeks (direct comparison of cognition during dialysis and on non-dialysis day)
Use of multi-domain neurocognitive battery to assess cognition during HD. Baseline cognition will be assessed on a non-dialysis day.
Within 2 weeks (direct comparison of cognition during dialysis and on non-dialysis day)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Mark D Findlay, MBChB, University of Glasgow

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mars 2015

Achèvement primaire (Anticipé)

1 août 2016

Achèvement de l'étude (Anticipé)

1 août 2017

Dates d'inscription aux études

Première soumission

26 février 2015

Première soumission répondant aux critères de contrôle qualité

18 mars 2015

Première publication (Estimation)

19 mars 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

19 mars 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 mars 2015

Dernière vérification

1 mars 2015

Plus d'information

Termes liés à cette étude

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

3
S'abonner