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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01353170
Other study ID # Basile calcium
Secondary ID
Status Completed
Phase N/A
First received May 9, 2011
Last updated May 11, 2011
Start date January 2010
Est. completion date September 2010

Study information

Verified date December 2010
Source Miulli General Hospital
Contact n/a
Is FDA regulated No
Health authority Italy: diocesi di Bari
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- bicarbonate hd since 6 months

- uncomplicated hd sessions

Exclusion Criteria:

- Incident patients

- unstable hd patients

- patients aged less than 18 years

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Calcium Mass Balances and Serum Calcium Profiling in hd Patients

Intervention

Other:
Dialysate calcium concentration
Calcium dialysate concentrations: 1.25, 1.35 and 1.5 mmol/l

Locations

Country Name City State
Italy Nephrology and dialysis unit Miulli General Hospital Acquaviva delle Fonti Bari

Sponsors (1)

Lead Sponsor Collaborator
Miulli General Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 4 hours No