|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
26 October 2015 |
|
Main ID: |
NCT02225431 |
|
Date of registration:
|
24/08/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Personalized Versus Standard Hydration for Prevention of CI-AKI: a Randomized Trial With Bioimpedance Analysis
|
|
Scientific title:
|
Personalized Versus Standard Hydration for Prevention of Contrast Induced Acute Kidney Injury. A Randomized Trial With Bioimpedance Analysis. |
|
Date of first enrolment:
|
September 2012 |
|
Target sample size:
|
296 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02225431 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Italy
| | | | | | | |
|
Contacts
|
|
Name:
|
Mauro Maioli, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Ospedale S. Stefano - Prato - Italy |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- consecutive patients admitted in Cardiology Unit for coronary or peripheral
angiography with "lower fluid status" defined on the basis bio-impedance analysis
(Male with resistance/height ratio > 315 Ohm/meter and Female > 380 Ohm/meter).
Exclusion Criteria:
- contrast medium administration within the 10 days
- end stage renal failure requiring dialysis
- refused to give informed consent
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Acute Kidney Injury
|
|
Intervention(s)
|
|
Drug: sodium chloride infusion
|
|
Primary Outcome(s)
|
|
Incidence of contrast-induced acute kidney injury
[Time Frame: 1 day]
|
|
Secondary Outcome(s)
|
|
Adverse clinical events
[Time Frame: 1 month]
|
|
Secondary ID(s)
|
|
Prato0706
|
|
2013/1
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|