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Calcium Concentration in Bicarbonate Hemodialysis (HD)

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ClinicalTrials.gov Identifier: NCT01353170
Recruitment Status : Completed
First Posted : May 12, 2011
Last Update Posted : May 12, 2011
Sponsor:
Information provided by:
Miulli General Hospital

Brief 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).

Condition or disease Intervention/treatment Phase
Calcium Mass Balances and Serum Calcium Profiling in hd Patients Other: Dialysate calcium concentration Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Among Different Dialysate Calcium Concentrations in Bicarbonate Hemodialysis
Study Start Date : January 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Dialysis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Prevalent hd patients
Patients undergoing three consecutive cross-over hd session with 3 different dialysate calcium concentrations
Other: Dialysate calcium concentration
Calcium dialysate concentrations: 1.25, 1.35 and 1.5 mmol/l



Primary Outcome Measures :
  1. Serum calcium concentrations [ Time Frame: 4 hours ]
    Evaluation of calcium mass balances and ionized calcium serum concentrations profiling during three hd sessions with different calcium concentrations in the dialysate



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • bicarbonate hd since 6 months
  • uncomplicated hd sessions

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01353170


Locations
Italy
Nephrology and dialysis unit Miulli General Hospital
Acquaviva delle Fonti, Bari, Italy, 70100
Sponsors and Collaborators
Miulli General Hospital

Responsible Party: Carlo Basile M D, Miulli GH
ClinicalTrials.gov Identifier: NCT01353170     History of Changes
Other Study ID Numbers: Basile calcium
First Posted: May 12, 2011    Key Record Dates
Last Update Posted: May 12, 2011
Last Verified: December 2010

Keywords provided by Miulli General Hospital:
Serum calcium
Dialysate
Mass balance
Blood pressure

Additional relevant MeSH terms:
Calcium, Dietary
Dialysis Solutions
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmaceutical Solutions