Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT02106234
Eligibility Criteria:
Inclusion criteria
* ≥18 years of age
* referred for an elective procedure with intravascular iodinated contrast material administration
* at risk of developing CIN according to the CBO prevention guidelines and referred for prophylactic intravenous hydration. \[the 4 high risk groups according to the guidelines are: 1. Kahler's disease (multiple myeloma) or Waldenström's macroglobulinemia with small chain proteinuria irrespective of eGFR; 2. eGFR \<45 ml/min/1.73m2; 3. eGFR \<60 ml/min/1.73m2 \& diabetes mellitus; 4. eGFR \<60 ml/min/1.73m2 \& ≥2 of the following risk factors: age\>75, anaemia, use of nephrotoxic medication such as diuretics or nonsteroidal anti-inflammatory drugs, cardiac /peripheral vascular disease.\]
Exclusion criteria
* No prophylactic treatment prescribed by referring physician
* Intensive care or emergency patient
* Patient receiving or having received renal replacement therapy
* Patients with severely decreased renal function (i.e. eGFR\<30ml/min/1.73m2)
No repeat inclusion will occur. We restrict our study to procedures where monomeric non-ionic low-osmolar iodinated contrast material is used.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02106234
Study Brief:
Protocol Section:
NCT02106234