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 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT02643602
Eligibility Criteria:
Inclusion Criteria:
Increased risk for contrast induced nephropathy defined as:
* Serum creatinine level ≥ 1.1 mg/dl OR
* Serum creatinine level ≥ 0.8 mg/dl plus an additional risk factor like diabetes mellitus, renal failure in past medical history or nephrotoxic medication (aminoglycoside, vancomycin, amphotericin B, diuretic)
Exclusion Criteria:
* pre-existing renal replacement therapy
* unstable serum creatinine levels (difference of more than ±0.4 mg/dl within 3 days before contrast application)
* contraindications for theophylline or sodium bicarbonate (allergies, tachycardia, alkalosis, hypokalemia)
* additional interventions that might influence renal function
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02643602
Study Brief:
Protocol Section:
NCT02643602