Design and challenges of the Randomized Evaluation of Normal versus Augmented Level Replacement Therapy (RENAL) Trial: high-dose versus standard-dose hemofiltration in acute renal failure
RENAL Study Investigators, Rinaldo Bellomo, Alan Cass, Louise Cole, Simon Finfer, Martin Gallagher, Donna Goldsmith, John Myburgh, Robyn Norton, Carlos Scheinkestel, David Ali, Rinaldo Bellomo, Alan Cass, Louise Cole, Simon Finfer, Martin Gallagher, Donna Goldsmith, Joanne Lee, John Myburgh, Robyn Norton, Carlos Scheinkestel, Ashoke Banarjee, Rinaldo Bellomo, Deepk Bhonagiri, David Blythe, John Botha, John Cade, Louise Cole, Geoff Dobb, John Eddington, Simon Finfer, Arthas Flabouris, Craig French, Peter Carrett, Seton Henderson, Benno Ihle, Chris Joye, Michael Kalkoff, Jeff Lipman, Colin McArthur, Shay McGinness, David Milliss, Imogen Mitchell, John Morgan, John Myburgh, Priya Nair, Neil Orford, Asif Raza, Carlos Scheinkestel, Yahya Shehabi, Antony Tobin, Richard Totaro, Andrew Turner, Christopher Wright, Jelena Gissane, Katya Malchukova, Imogen Mitchell, Jamie Ranse, Asif Raza, Sara Treena, David Millis, Jeff Tan, Elise Crowfoot, Peter Harrigan, Deepak Bhonagiri, Sharon Micallef, Jorge Brieva, Melissa Lintott, Louise Cole, Rebecca Gresham, Maria Nikas, Leonie Weisbrodt, Frances Bass, Michelle Campbell, Yahya Shehabi, Susan Ankers, Simon Finfer, Anne O'Connor, Julie Potter, Dorrilyn Rajbhandari, Richard Totaro, Alina Jovanovska, Francesca Munster, John Myburgh, Jeff Breeding, Claire Burns, Priya Nair, Ashoke Banerjee, Caroline Pfeffercorn, Anne Ritchie, Michelle Ecckleston, Shay McGuinness, Rachael Parke, Jeanette Bell, Colin McArthur, Lynette Newby, Seton Henderson, Jan Mehrtens, Michael Kalkoff, Cathy West, John Morgan, Lorraine Rudder, Joanne Sutton, Peter Garrett, Nicole Groves, Jennifer Palmer, Jean Helyar, Chris Joyce, Benjamin Mackie, Claire Bertenshaw, Renae Deans, Cheryl Fourie, Melissa Lassig-Smith, Jeff Lipman, Jason Edwards, Arthus Flabouris, Stephanie O'Connor, Justine Rivett, Andrew Turner, Tanya Field, Kathryn Marsden, Rinaldo Bellomo, Donna Goldsmith, Kim O'Sullivan, Catherine Boschert, John Edington, Julie Smith, Michael Graan, Samuel Ho, Benno Ihle, John Botha, Nina Fowler, Jodi McInness, Naomi Pratt, Tania Elderkin, Neil Orford, Sue Burton, Carly Culhane, Pauline Galt, Rebecca Rutzou, Christopher Wright, Deborah Barge, Tania Caf, Belinda Howe, Patzy Low, Megan Roberston, Nicole Groves, Jennifer Holmes, Roger Smith, Antony Tobin, Rachael Nevill, Carlos Scheinkestel, Vicki White, Craig French, Lorraine Little, Heike Raunow, David Blythe, Anna Palermo, Melanie Boardman, Jenny Chamberlain, Geoff Dobb, Andree Gould, Geraldine McEntaggart, Samantha Perryman, Linda Thomas, RENAL Study Investigators, Rinaldo Bellomo, Alan Cass, Louise Cole, Simon Finfer, Martin Gallagher, Donna Goldsmith, John Myburgh, Robyn Norton, Carlos Scheinkestel, David Ali, Rinaldo Bellomo, Alan Cass, Louise Cole, Simon Finfer, Martin Gallagher, Donna Goldsmith, Joanne Lee, John Myburgh, Robyn Norton, Carlos Scheinkestel, Ashoke Banarjee, Rinaldo Bellomo, Deepk Bhonagiri, David Blythe, John Botha, John Cade, Louise Cole, Geoff Dobb, John Eddington, Simon Finfer, Arthas Flabouris, Craig French, Peter Carrett, Seton Henderson, Benno Ihle, Chris Joye, Michael Kalkoff, Jeff Lipman, Colin McArthur, Shay McGinness, David Milliss, Imogen Mitchell, John Morgan, John Myburgh, Priya Nair, Neil Orford, Asif Raza, Carlos Scheinkestel, Yahya Shehabi, Antony Tobin, Richard Totaro, Andrew Turner, Christopher Wright, Jelena Gissane, Katya Malchukova, Imogen Mitchell, Jamie Ranse, Asif Raza, Sara Treena, David Millis, Jeff Tan, Elise Crowfoot, Peter Harrigan, Deepak Bhonagiri, Sharon Micallef, Jorge Brieva, Melissa Lintott, Louise Cole, Rebecca Gresham, Maria Nikas, Leonie Weisbrodt, Frances Bass, Michelle Campbell, Yahya Shehabi, Susan Ankers, Simon Finfer, Anne O'Connor, Julie Potter, Dorrilyn Rajbhandari, Richard Totaro, Alina Jovanovska, Francesca Munster, John Myburgh, Jeff Breeding, Claire Burns, Priya Nair, Ashoke Banerjee, Caroline Pfeffercorn, Anne Ritchie, Michelle Ecckleston, Shay McGuinness, Rachael Parke, Jeanette Bell, Colin McArthur, Lynette Newby, Seton Henderson, Jan Mehrtens, Michael Kalkoff, Cathy West, John Morgan, Lorraine Rudder, Joanne Sutton, Peter Garrett, Nicole Groves, Jennifer Palmer, Jean Helyar, Chris Joyce, Benjamin Mackie, Claire Bertenshaw, Renae Deans, Cheryl Fourie, Melissa Lassig-Smith, Jeff Lipman, Jason Edwards, Arthus Flabouris, Stephanie O'Connor, Justine Rivett, Andrew Turner, Tanya Field, Kathryn Marsden, Rinaldo Bellomo, Donna Goldsmith, Kim O'Sullivan, Catherine Boschert, John Edington, Julie Smith, Michael Graan, Samuel Ho, Benno Ihle, John Botha, Nina Fowler, Jodi McInness, Naomi Pratt, Tania Elderkin, Neil Orford, Sue Burton, Carly Culhane, Pauline Galt, Rebecca Rutzou, Christopher Wright, Deborah Barge, Tania Caf, Belinda Howe, Patzy Low, Megan Roberston, Nicole Groves, Jennifer Holmes, Roger Smith, Antony Tobin, Rachael Nevill, Carlos Scheinkestel, Vicki White, Craig French, Lorraine Little, Heike Raunow, David Blythe, Anna Palermo, Melanie Boardman, Jenny Chamberlain, Geoff Dobb, Andree Gould, Geraldine McEntaggart, Samantha Perryman, Linda Thomas
Abstract
Background/aims: The optimal dose of renal replacement therapy (RRT) in acute renal failure (ARF) is uncertain.
Methods: The Randomized Evaluation of Normal versus Augmented Level Replacement Therapy Trial tests the hypothesis that higher dose continuous veno-venous hemodiafiltration (CVVHDF) at an effluent rate of 40 ml/kg/h will increase survival compared to CVVHDF at 25 ml/kg/h of effluent dose.
Results: This trial is currently randomizing critically ill patients in 35 intensive care units in Australia and New Zealand with a planned sample size of 1,500 patients. This trial will be the largest trial ever conducted on acute blood purification in critically ill patients.
Conclusion: A trial of this magnitude and with demanding technical requirements poses design difficulties and challenges in the logistics, conduct, data collection, data analysis and monitoring. Our report will assist in the development of future trials of blood purification in intensive care.
Trial registration: ClinicalTrials.gov NCT00221013.
Source: PubMed