DialysisEMTDialyseNCT05031013
Trace Elements Concentration in Dialysis
An observational study of Dialysis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dialysis
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2021to Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Dialysis patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Nephrology Department and Dialysis Unit
Boulogne-Billancourt, 92100
About this study
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).
Read the detailed description
Primary objective: Evaluate the trace element concentration (heavy metals Cd and Pb and oligometals: Fe, Zn, Cu, Mn and also Se) in the dialysate before and during dialysis session. By studying the variation in concentration between the initial concentration of trace element in the dialysis fluid and the final concentration after membrane in the dialysate (waste pipe).
Method : Prospective study, in dialysis population, inclusion period will be from September 1, 2021 to January 31, 2022, in Ambroise Paré hospital, Paris, France. Duration of follow-up will be 1 day.
Dialysate samples will be taken in the venous injection site before connecting the patient, at 0 and 10 minutes after disinfection.
After connecting the patients, post-membrane dialysis sample (waste pipe) will be taken at 30, 60, 120 and 180minutes. Trace element dosage will be done by ICP-MS.
- Conditions
- Dialysis
- Keywords
- dialysis, trace elements concentration, cadmium, lead
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dialysis patients | Dialysis patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trace elements concentration
Trace elements concentration in the dialysate during dialysis sessions by inductive coupled plasma mass-spectrometry (ICP-MS).
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study startSep 2021 (estimated)
- Primary completion31 Jan 2022 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for DialysisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- laboratoire ILM - Université Lyon 1 CNRS, UMR 5306 UCBL, MEXBrain 13 avenue Albert Einstein 69100 Villeurbanne
- Responsible party
- Sponsor
- Investigators
- Aymeric Couturier, MD, Principal investigator, Service néphrologie et dialyse, hôpital Ambroise Paré
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031013
- Sponsor's protocol ID
- 021ACR-EMTDialyse
- Acronym
- EMTDialyse
- Status last verified
- Aug 2021
- First submitted
- 30 Aug 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28838766Prodanchuk 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.
PubMed 24757548Orr 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.
PubMed 28498320Messner 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.
PubMed 19556524Lee 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.
PubMed 27175714Sotomayor 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.
PubMed 32941876Larsson 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.
PubMed 25997435Satarug 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.
PubMed 33066165Roozbeh 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.
PubMed 21529280
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trace Elements Concentration in Dialysis
- ClinicalTrials.gov ID
- NCT05031013
- Acronym / sponsor ID
- EMTDialyse / 021ACR-EMTDialyse
- Conditions
- Dialysis
- Keywords
- dialysis, trace elements concentration, cadmium, lead
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- laboratoire ILM - Université Lyon 1 CNRS, UMR 5306 UCBL, MEXBrain 13 avenue Albert Einstein 69100 Villeurbanne
- Study start
- Sep 2021 (estimated)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Primary objective: Evaluate the trace element concentration (heavy metals Cd and Pb and oligometals: Fe, Zn, Cu, Mn and also Se) in the dialysate before and during dialysis session. By studying the variation in concentration between the initial concentration of trace element in the dialysis fluid and the final concentration after membrane in the dialysate (waste pipe).
Method : Prospective study, in dialysis population, inclusion period will be from September 1, 2021 to January 31, 2022, in Ambroise Paré hospital, Paris, France. Duration of follow-up will be 1 day.
Dialysate samples will be taken in the venous injection site before connecting the patient, at 0 and 10 minutes after disinfection.
After connecting the patients, post-membrane dialysis sample (waste pipe) will be taken at 30, 60, 120 and 180minutes. Trace element dosage will be done by ICP-MS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dialysis patients | – | –Dialysis patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Dialysis patients
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Trace elements concentration
Time frame: 5 months
Trace elements concentration in the dialysate during dialysis sessions by inductive coupled plasma mass-spectrometry (ICP-MS).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Background: PubMed 28838766Tonelli 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.
- Background: PubMed 24757548Prodanchuk 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.
- Background: PubMed 28498320Orr 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.
- Background: PubMed 19556524Messner 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.
- Background: PubMed 27175714Lee 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.
- Background: PubMed 32941876Sotomayor 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.
- Background: PubMed 25997435Larsson 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.
- Background: PubMed 33066165Satarug 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.
- Background: PubMed 21529280Roozbeh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aymeric Couturier, MD principal investigator
Service néphrologie et dialyse, hôpital Ambroise Paré
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dialysis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aymeric Couturier, MD (+33171167685, aymeric.couturier@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trace elements concentration (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05031013, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.