Calcium Concentration in Bicarbonate Hemodialysis (HD)

This study has been completed.
Sponsor:
Information provided by:
Miulli General Hospital
ClinicalTrials.gov Identifier:
NCT01353170
First received: May 9, 2011
Last updated: May 11, 2011
Last verified: December 2010
  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: 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01353170

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

No publications provided

Responsible Party: Carlo Basile M D, Miulli GH
ClinicalTrials.gov Identifier: NCT01353170     History of Changes
Other Study ID Numbers: Basile calcium
Study First Received: May 9, 2011
Last Updated: May 11, 2011
Health Authority: Italy: diocesi di Bari

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

Additional relevant MeSH terms:
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014