Trace Elements Concentration in Dialysis

NCT05031013 | Unknown

• 1 other identifier: 021ACR-EMTDialyse
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In hemodialysis population the study team finds high concentrations of toxic trace elements (2 times higher than the general population for cadmium 4 to 13 times for lead). Several recent studies suggest a role of chronic exposure to cadmium in the loss of residual renal function, osteoporosis, graft failure, arteriosclerosis, as well as in excess cardiovascular mortality. Moreover, in hemodialysis population, a deficit of certain essential trace elements (manganese, selenium, zinc) is observed. For example, in the population undergoing chronic hemodialysis, a zinc deficiency is found in 40 to 78% of cases. Zinc is a cofactor of more than 70 enzymes. In this observational cohort, the study team seeks to understand the impact of HD and HDF on the serum concentrations of heavy metals and also oligometals, by studying their concentrations in the dialysate during dialysis sessions by inductive coupled plasma mass-spectrometry (ICP-MS).

Conditions

Dialysis

Keywords

dialysis; trace elements concentration; cadmium; lead

Outcome Measures

Primary Outcomes (1)

• Trace elements concentration

  Trace elements concentration in the dialysate during dialysis sessions by inductive coupled plasma mass-spectrometry (ICP-MS).

  5 months

Study Arms (1)

Dialysis patients

Dialysis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Dialysis patients

You may qualify if:

• Age over 18;
• End-stage chronic renal failure in chronic dialysis;
• Duration of dialysis session ≥3h;
• Vascular approach: arteriovenous fistula;
• Affiliation to a social security scheme or entitled.

You may not qualify if:

• Opposition to participate to the study;
• Daily dialysis;
• Duration of dialysis session \< 3h and \> 8h;
• Vascular approach: venous catheter; Weekly dialysis session ≤3; Patient under french AME health system.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• laboratoire ILM - Université Lyon 1 CNRS, UMR 5306 UCBL: collaborator
• MEXBrain 13 avenue Albert Einstein 69100 Villeurbanne: collaborator

Study Sites (1)

Nephrology Department and Dialysis Unit

Boulogne-Billancourt, 92100, France

Location

Related Publications (9)

• Tonelli M, Wiebe N, Bello A, Field CJ, Gill JS, Hemmelgarn BR, Holmes DT, Jindal K, Klarenbach SW, Manns BJ, Thadhani R, Kinniburgh D; Alberta Kidney Disease Network. Concentrations of Trace Elements in Hemodialysis Patients: A Prospective Cohort Study. Am J Kidney Dis. 2017 Nov;70(5):696-704. doi: 10.1053/j.ajkd.2017.06.029. Epub 2017 Aug 31.

  PMID: 28838766 BACKGROUND

• Prodanchuk M, Makarov O, Pisarev E, Sheiman B, Kulyzkiy M. Disturbances of trace element metabolism in ESRD patients receiving hemodialysis and hemodiafiltration. Cent European J Urol. 2014;66(4):472-6. doi: 10.5173/ceju.2013.04.art23. Epub 2014 Jan 27.

  PMID: 24757548 BACKGROUND

• Orr SE, Bridges CC. Chronic Kidney Disease and Exposure to Nephrotoxic Metals. Int J Mol Sci. 2017 May 12;18(5):1039. doi: 10.3390/ijms18051039.

  PMID: 28498320 BACKGROUND

• Messner B, Knoflach M, Seubert A, Ritsch A, Pfaller K, Henderson B, Shen YH, Zeller I, Willeit J, Laufer G, Wick G, Kiechl S, Bernhard D. Cadmium is a novel and independent risk factor for early atherosclerosis mechanisms and in vivo relevance. Arterioscler Thromb Vasc Biol. 2009 Sep;29(9):1392-8. doi: 10.1161/ATVBAHA.109.190082. Epub 2009 Jun 25.

  PMID: 19556524 BACKGROUND

• Lee CC, Weng CH, Huang WH, Yen TH, Lin JL, Lin-Tan DT, Chen KH, Hsu CW. Association Between Blood Cadmium Levels and Mortality in Peritoneal Dialysis. Medicine (Baltimore). 2016 May;95(19):e3717. doi: 10.1097/MD.0000000000003717.

  PMID: 27175714 BACKGROUND

• Sotomayor CG, Groothof D, Vodegel JJ, Eisenga MF, Knobbe TJ, IJmker J, Lammerts RGM, de Borst MH, Berger SP, Nolte IM, Rodrigo R, Slart RHJA, Navis GJ, Touw DJ, Bakker SJL. Plasma cadmium is associated with increased risk of long-term kidney graft failure. Kidney Int. 2021 May;99(5):1213-1224. doi: 10.1016/j.kint.2020.08.027. Epub 2020 Sep 14.

  PMID: 32941876 BACKGROUND

• Larsson SC, Wolk A. Urinary cadmium and mortality from all causes, cancer and cardiovascular disease in the general population: systematic review and meta-analysis of cohort studies. Int J Epidemiol. 2016 Jun;45(3):782-91. doi: 10.1093/ije/dyv086. Epub 2015 May 20.

  PMID: 25997435 BACKGROUND

• Satarug S, C Gobe G, A Vesey D, Phelps KR. Cadmium and Lead Exposure, Nephrotoxicity, and Mortality. Toxics. 2020 Oct 13;8(4):86. doi: 10.3390/toxics8040086.

  PMID: 33066165 BACKGROUND

• Roozbeh J, Sharifian M, Sagheb MM, Shabani S, Hamidian Jahromi A, Afshariani R, Pakfetrat M, Salehi O. Comment on: does zinc supplementation affect inflammatory markers in hemodialysis patients? Ren Fail. 2011;33(4):466-7. doi: 10.3109/0886022X.2011.568144. No abstract available.

  PMID: 21529280 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

dialysat samples

Study Officials

• Aymeric Couturier, MD

  Service néphrologie et dialyse, hôpital Ambroise Paré

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aymeric Couturier, MD

CONTACT

+33171167685; aymeric.couturier@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 1, 2021
• Study Start: September 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: February 1, 2022
• Last Updated: September 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)