Contrast-induced Nephropathy — Contrast-Induced Nephropathy After Revision of the Prophylaxis Threshold
Citation(s)
Centraal BegeleidingsOrgaan (CBO) CBO richtlijnen contrast. 2007 Available from: www.cbo.nl/product/richtlijnen/folder20021023121843/rl_jodium_2007
Nijssen EC, Rennenberg RJ, Nelemans PJ, Essers BA, Janssen MM, Vermeeren MA, Ommen VV, Wildberger JE Prophylactic hydration to protect renal function from intravascular iodinated contrast material in patients at high risk of contrast-induced nephropathy (AMACING): a prospective, randomised, phase 3, controlled, open-label, non-inferiority trial. Lancet. 2017 Apr 1;389(10076):1312-1322. doi: 10.1016/S0140-6736(17)30057-0. Epub 2017 Feb 21.
Veligheids Management Systeem VMS veiligheidsprogramma. Voorkomen van nierinsufficiëntie bij intravasculair gebruik van jodiumhoudende contrastmiddelen. September 2009. 2009 [cited; Available from: http:/www.vmszorg.nl/10- Themas/Nierinsufficientie/Praktijkgids-Nierinsufficientie
Contrast-Induced Nephropathy After Revision of the Prophylaxis Threshold
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
