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Calcium Concentration in Bicarbonate Hemodialysis (HD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01353170
First Posted: May 12, 2011
Last Update Posted: May 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Miulli General Hospital
  Purpose
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 Intervention
Calcium Mass Balances and Serum Calcium Profiling in hd Patients Other: Dialysate calcium concentration

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Miulli General Hospital:

Primary Outcome Measures:
  • 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


Enrollment: 22
Study Start Date: January 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

Responsible Party: Carlo Basile M D, Miulli GH
ClinicalTrials.gov Identifier: NCT01353170     History of Changes
Other Study ID Numbers: Basile calcium
First Submitted: May 9, 2011
First Posted: May 12, 2011
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