Sodium Bicarbonate for the prevention of Contrast Induced Nephropathy in patients undergoing CTPA - The Nephros Study
- Conditions
- The prevention of Contrast Induced Nephropathy is under investigation.Contrast induced nephropathy (CIN) can occur after injecting radiographic iso osmolair contrast media. Patients with a renal impairment or a decreased renal function and aspecially in combination with diabetis mellitus are at risk for developing CIN.MedDRA version: 12.0Level: LLTClassification code 10037790Term: Radiocontrast nephropathy
- Registration Number
- EUCTR2009-013547-11-NL
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
-estimated glomerular filtration rate (eGFR) < 60 ml/min
- clinical suspected acute pulmonary embolism with an indication for CTPA with intravenous administration of iso osmolar contrast media.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- Age < 18 years
- Exposure to radiographic contrast media within 7 days
- Pregnancy
- Systolic bloodpressure < 100 mmHg
- Allergy for contrast media
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): - Mean increase in serum creatinine 2-4 days after CTPA;Main Objective: -Evaluation of the mean increase in serum creatinine following CTPA (CT- pulmonary angiography) without prehydration compaired to a short prehydration regime with sodium bicarbonate during one hour.;Secondary Objective: -Evaluation of the incidence of CIN following CTPA without prehydration compaired to a short prehydration regime with sodium bicarbonate during one hour.<br>-Furthermore, the risk of developing CIN after CTPA with iso-osmolair contrast media is studied for both patient groups
- Secondary Outcome Measures
Name Time Method