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CompletedNCT01353170Updated May 12, 2011

Calcium Concentration in Bicarbonate Hemodialysis (HD)

An interventional study of Dialysate calcium concentration in Calcium Mass Balances and Serum Calcium Profiling in hd Patients, sponsored by Miulli General Hospital. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-12.

Sponsored by Miulli General Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The study was designed in order to investigate the effects of 3 different dialysate calcium concentrations may exert on mineral metabolism and hemodynamic stability in standard hemodialysis (hd).

02

Conditions studied

  • Calcium Mass Balances and Serum Calcium Profiling in hd Patients

Keywords

  • Serum calcium
  • Dialysate
  • Mass balance
  • Blood pressure
03

In context

Lead sponsor

Miulli General Hospital is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • bicarbonate hd since 6 months
  • uncomplicated hd sessions

Exclusion criteria

Exclusion Criteria:

  • Incident patients
  • unstable hd patients
  • patients aged less than 18 years
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Prevalent hd patients

    Patients undergoing three consecutive cross-over hd session with 3 different dialysate calcium concentrations

    Other: Dialysate calcium concentration

Interventions

  • OtherDialysate calcium concentration

    Calcium dialysate concentrations: 1.25, 1.35 and 1.5 mmol/l

06

What researchers measure

Primary outcomes

  1. Serum calcium concentrations

    Evaluation of calcium mass balances and ionized calcium serum concentrations profiling during three hd sessions with different calcium concentrations in the dialysate

    Time frame: 4 hours

07

Study locations

1 site
  • Nephrology and dialysis unit Miulli General Hospital
    Acquaviva delle Fonti, Bari 70100, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01353170
Lead sponsor
Miulli General Hospital
First posted
May 12, 2011
Start date
Jan 2010
Primary completion
Sep 2010
Completion
Sep 2010
Last update
May 12, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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