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Clinical Trials/NCT03119818
NCT03119818
Completed
Not Applicable

Intracellular Phosphate and Adenosine Triphosphate (ATP) Concentration Evolution by Magnetic Resonance (MR) Spectroscopy in Patients During Hemodialysis

Hospices Civils de Lyon1 site in 1 country11 target enrollmentJune 14, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
End-Stage Renal Disease (ESRD)
Sponsor
Hospices Civils de Lyon
Enrollment
11
Locations
1
Primary Endpoint
Change in phosphate intracellular concentration
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

End-stage renal disease is associated with hyperphosphatemia due to a decrease of renal phosphate excretion. This hyperphosphatemia is associated with an increase of cardiovascular risk and mortality. Thus, three therapeutic options have been developed: dietary restriction, administration of phosphate binders and phosphorus clearance by hemodialysis (HD).

During a standard HD session, around 600 to 700mg phosphate is removed from the plasma, whereas it contains only 90 mg inorganic phosphate (Pi); 85% of phosphate is stored in bones and teeth in hydroxyapatite form, 14% is stored in the intracellular space (90% organic phosphate and 10% Pi), and 1% remains in the extracellular space.

Currently, the source of Pi cleared during HD remains to be determined. Phosphorus (31P) magnetic resonance spectroscopy allows reliable, dynamic and non-invasive measurements of phosphate intracellular concentration. The investigator's team recently published data obtained in anephric pigs, suggesting that phosphate intracellular concentration increases during a HD session. In parallel, we showed that ATP intracellular concentration decreased. These results suggest that the source of Pi cleared during HD could be located inside the cell.

In this study, investigators will measure intracellular phosphate and ATP concentrations and intracellular potential of hydrogen (pH) evolution during hemodialysis in 12 patients suffering from end-stage renal disease by MR spectroscopy.

If these results were confirmed in humans, it could explain, at least in part, HD intolerance in some patients and would lead to modify therapeutic approaches of hyperphosphatemia, for example, by modifying HD sessions time.

Registry
clinicaltrials.gov
Start Date
June 14, 2017
End Date
July 29, 2017
Last Updated
4 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient suffering from end-stage renal disease, treated by chronic hemodialysis since at less 6 months
  • Phosphatemia (at the start of the session) ≥ 1,5 mmol/L and ≤ 3 mmol/L
  • written consent signed

Exclusion Criteria

  • Major subject protected by law
  • Prisoners or subjects who are involuntarily incarcerated
  • Denutrition (weight loss ≥ 5 kg in one months/10 kg in 6 months, Body Mass Index (BMI) ≤ 21 kg/m2, albuminemia ≤ 35 g/L)
  • Obesity (BMI ≥ 30 kg/m2)
  • Phosphatemia at the start of the dialysis \< 1,5 mmol/L or \> 3 mmol/L
  • Secondary hyperparathyroidism with parathormone (PTH) ≥ 1000 pg/mL
  • Adynamic osteopathy (PTH ≤ 50 pg/mL)
  • Hypoparathyroidism with a history of parathyroidectomy
  • Hemoglobin ≤ 100 g/L
  • Contraindication to heparin

Outcomes

Primary Outcomes

Change in phosphate intracellular concentration

Time Frame: Baseline, at start of HD, every 160 seconds during HD, at the end of HD and 30 minutes after HD

Measurement of phosphate intracellular concentration evolution during a 4 hours hemodialysis (HD) session using phosphorus magnetic resonance spectroscopy.

Secondary Outcomes

  • Change in ATP intracellular concentration(Baseline, at start of HD, every 160 seconds during HD, at the end of HD and 30 minutes after HD)
  • Change in intracellular pH(Baseline, at start of HD, every 160 seconds during HD, at the end of HD and 30 minutes after HD)
  • Change in phosphatemia(At start of HD, every 15 minutes during first hour of HD, then every hour during HD, at the end of HD and 30 minutes after HD)
  • Calcium balance(At the end of a 4 hours HD session)

Study Sites (1)

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