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A randomized trial to increase the efficiency of the prevention of contrast induced acute kidney injury. The Compass trial

Phase 4
Completed
Conditions
contrast induced nephropathy
10029149
contrast induced acute kidney injury
Registration Number
NL-OMON39573
Lead Sponsor
eids Universitair Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
575
Inclusion Criteria

- patients with an eGFR (estimated glomerular filtration rate 30-45 ml/min)
- patients with an eGFR 45-60 ml/min and diabetes mellitus (either type 1 or 2)
- patients with an eGFR 45-60 ml/min and at least two of the following: peripheral artery disease, congestive heart failure, age > 75 years, anemia, contrastvolumes > 150 cc or the use of nephrotoxic medication
- informed consent

Exclusion Criteria

- eGFR < 30 ml/min
- Age < 18 years
- Patients with other intravenous contrast administrations (including intravenous contrast enhanced MRI) < 7 days of study CT-scan OR in 5 days following study CT-scan
- pregnancy
- renal transplantation in the last 3 years
- previous participation to the Compass trial
- dehydrated patients (systolic blood pressure < 100 mmHg)
- proven instable renal function in the four weeks prior to randomisation (increase or decrease in serum creatinine > 20%)
- known allergy for iodinated contrast media

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>- Mean relative increase in serum creatinine</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>- incidence of CIN<br /><br>- recovery of renal function 2 months after CT in patients who developed CIN<br /><br>- mean relative increase in serum creatinine 7-14 days after contrast<br /><br>administration<br /><br>- acute kidney injury according to the serum creatinine based RIFLE criteria<br /><br>- the need for dialysis<br /><br>- (re)hospitalisation, duration of hospitalisation in the two months following<br /><br>randomisation<br /><br>- visits to the outpatient clinic in the two months following randomisation</p><br>
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