End-Stage Renal Disease — Urgent-start Peritoneal Dialysis in ESRD Patients:A Multi-center Study
Citation(s)
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Ivarsen P, Povlsen JV Can peritoneal dialysis be applied for unplanned initiation of chronic dialysis? Nephrol Dial Transplant. 2014 Dec;29(12):2201-6. doi: 10.1093/ndt/gft487. Epub 2013 Dec 17.
Koch M, Kohnle M, Trapp R, Haastert B, Rump LC, Aker S Comparable outcome of acute unplanned peritoneal dialysis and haemodialysis. Nephrol Dial Transplant. 2012 Jan;27(1):375-80. doi: 10.1093/ndt/gfr262. Epub 2011 May 28.
Liu Y, Zhang L, Lin A, Ni Z, Qian J, Fang W Impact of break-in period on the short-term outcomes of patients started on peritoneal dialysis. Perit Dial Int. 2014 Jan-Feb;34(1):49-56. doi: 10.3747/pdi.2012.00293.
Povlsen JV, Ivarsen P How to start the late referred ESRD patient urgently on chronic APD. Nephrol Dial Transplant. 2006 Jul;21 Suppl 2:ii56-9. doi: 10.1093/ndt/gfl192.
Povlsen JV, Sorensen AB, Ivarsen P Unplanned Start on Peritoneal Dialysis Right after PD Catheter Implantation for Older People with End-Stage Renal Disease. Perit Dial Int. 2015 Nov;35(6):622-4. doi: 10.3747/pdi.2014.00347.
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.