Hydroxyethyl starch or saline for fluid resuscitation in intensive care

John A Myburgh, Simon Finfer, Rinaldo Bellomo, Laurent Billot, Alan Cass, David Gattas, Parisa Glass, Jeffrey Lipman, Bette Liu, Colin McArthur, Shay McGuinness, Dorrilyn Rajbhandari, Colman B Taylor, Steven A R Webb, CHEST Investigators, Australian and New Zealand Intensive Care Society Clinical Trials Group, John Myburgh, Simon Finfer, Rinaldo Bellomo, Laurent Billot, Alan Cass, David Gattas, Parisa Glass, Bette Liu, Jeff Lipman, Colin McArthur, Shay McGuinness, Dorrilyn Rajbhandari, Colman Taylor, Steve Webb, John Myburgh, Rinaldo Bellomo, Alan Cass, Maryam Correa, Simon Finfer, David Gattas, Parisa Glass, Julie Harland, Joanne Lee, Bette Liu, Jeff Lipman, Colin McArthur, Shay McGuinness, Maryanne Ng, Dorrilyn Rajbhandari, Colman Taylor, Steve Webb, Duncan Young, Deborah Cook, Ian Roberts, Jodi Brown, Eileen Gilder, Shay McGuinness, Rachael Parke, Rinaldo Bellomo, Glenn Eastwood, Leah Peck, Stephen Warrillow, Helen Young, Catherine Boschert, Emma Broadfield, John Edington, Jason Fletcher, Gary Koch, Sanjay Porwal, Julie Smith, Kiran Nand, Latesh Poojara, Graham Reece, Treena Sara, Katrina Ellem, Suzanna Vale, Sean Chan, Elisha Fulton, Anne Leditschke, Imogen Mitchell, Katrina Sowiak, Josie Russell-Brown, Helen Rodgers, Elise Taylor, Frank van Haren, Rachel Whyte, David Bowie, Alastair Gibson, Seton Henderson, Louise Hitchings, David Knight, Jan Mehrtens, Sascha Noble, David Sugden, Geoff Shaw, Winston Cheung, Peter Lawrence, David Milliss, Govindasamy Thanakrishnan, Helen Wong, Benno Ihle, Lavan Padayachee, Vasantha Pather, Megan Robertson, Sharon Allsop, John Botha, Kavi Haji, Kate Jones, David Blythe, Vivienne Butler, Bart De Keulenaer, Annamaria Palermo, Allison Bone, Claire Cattigan, Tania Elderkin, Melissa Fraser, Neil Orford, Tania Salerno, Miranda Hardie, Peter Harrigan, Anders Aneman, Amjed Aziz, Sharon Micallef, Sharyn Parker, Michael Parr, Tracy Parrish, Victor Tam, Benoj Varghese, John Morgan, Jeff Presneill, Joanne Sutton, Robyn Bond, Louise Cole, Cheryl Cuzner, Rebecca Gresham, Maria Nikas, Phoebe Palejs, Ian Seppelt, Leonie Weisbrodt, Sarah Whereat, Jeanette Bell, Annette Flanagan, Umit Holland, Ywain Lawrey, Janet Liang, Graeme Duke, John Green, Mary Park, Michael Reade, Jasmin Sungkar, Frances Bass, David Bihari, Pam Edhouse, Maryam Sana, Yahya Shehabi, Alison Walker, Rob Boots, Renae Deans, Rachel Dunlop, Paul Jarrett, Melissa Lassig-Smith, Jeffrey Lipman, Therese Starr, Janine Stuart, Lisa Wang, Allan Beswick, David Cooper, Rick McAllister, David Rigg, Andrew Turner, Frances Bass, Simon Bird, Celia Bradford, Anthony Delaney, Simon Finfer, Carol Foote, Roger Harris, Naomi Hammond, Richard Lee, Lewis Macken, Grainne McEvoy, Anne O'Connor, Julie Potter, Raymond Raper, Elizabeth Steel, Elizabeth Yarad, Heidi Buhr, Jodie Cowell, Mark Daley, David Gattas, Spoorthi Gowda, Robert Herkes, Robert Hislop, Liarna Honeysett, Heike Koelzow, Mark Lucey, Michael O'Leary, Paul Phipps, Dorrilyn Rajbhandari, Caitlin Rees, Richard Totaro, Clive Woolfe, Deb Inskip, Jennene Miller, John Myburgh, Manoj Saxena, Rebecca Sidoli, Jennifer Holmes, John Santamaria, Roger Smith, Antony Tobin, Troy Browne, Denise Bryers, Jennifer Goodson, James Houghton, Shirley Nelson, John Durning, Annette Forrest, Mary La Pine, Geoffrey McCracken, Helen Terlesk, Frank van Haren, Lynn Andrews, Ben Barry, Richard Dinsdale, Helen Golds, Peter Hicks, Diane Mackle, Jessica Ongley, Tania Phillips, Chris Poynter, Alex Psirides, Shawn Sturland, Robert Ure, Bronwyn Williams, Paul Young, Amy Partanen, Ranald Pascoe, Brenda Rosser, Amanda Stanton, Ashley Trehane, Bala Venkatesh, Samantha Bates, Jenie Butler, Lyndal Keen, Forbes McGain, Anna Tippett, Ashoke Banerjee, Peter Clark, Jing Kong, Maridy Morrison, Vineet Nayyar, Christina Skelly, Edward Stachowski, Rinaldo Bellomo, Alan Cass, Arina Dan, Simon Finfer, David Gattas, Parisa Glass, Naomi Hammond, Stephen Jan, Bette Liu, Stephen MacMahon, John Myburgh, Robyn Norton, Vlado Perkovic, Colman Taylor, Maryam Correa, Donna Goldsmith, Ann Gould, Dijlah Hannah, Meg Harward, Louise Ham, Julie Harland, Joanne Lee, Ashleigh Myburgh, Maryanne Ng, Dorrilyn Rajbhandari, Suzie Ryan, Kelly Thompson, Bala Vijayan, Lynsey Willenberg, Laurent Billot, Severine Bompoint, Stephane Heritier, Qiang Li, Jayanthi Mysore, Ross Bidencope, Joanne Cole, Richard Fisher, Dan Kramer, Tim Regan, Jean-Francois Baron, Frank Bepperling, Thomas Gottwald, Martin Holler, Cornelius Jungheinrich, Hrishikesh Kulkarni, Marc Maltas, Bernard Ott, Martin Westphal, Geoff Godfrey, David Marando, Sue Miles, Andrew Minton, Jeremy Simpson, John A Myburgh, Simon Finfer, Rinaldo Bellomo, Laurent Billot, Alan Cass, David Gattas, Parisa Glass, Jeffrey Lipman, Bette Liu, Colin McArthur, Shay McGuinness, Dorrilyn Rajbhandari, Colman B Taylor, Steven A R Webb, CHEST Investigators, Australian and New Zealand Intensive Care Society Clinical Trials Group, John Myburgh, Simon Finfer, Rinaldo Bellomo, Laurent Billot, Alan Cass, David Gattas, Parisa Glass, Bette Liu, Jeff Lipman, Colin McArthur, Shay McGuinness, Dorrilyn Rajbhandari, Colman Taylor, Steve Webb, John Myburgh, Rinaldo Bellomo, Alan Cass, Maryam Correa, Simon Finfer, David Gattas, Parisa Glass, Julie Harland, Joanne Lee, Bette Liu, Jeff Lipman, Colin McArthur, Shay McGuinness, Maryanne Ng, Dorrilyn Rajbhandari, Colman Taylor, Steve Webb, Duncan Young, Deborah Cook, Ian Roberts, Jodi Brown, Eileen Gilder, Shay McGuinness, Rachael Parke, Rinaldo Bellomo, Glenn Eastwood, Leah Peck, Stephen Warrillow, Helen Young, Catherine Boschert, Emma Broadfield, John Edington, Jason Fletcher, Gary Koch, Sanjay Porwal, Julie Smith, Kiran Nand, Latesh Poojara, Graham Reece, Treena Sara, Katrina Ellem, Suzanna Vale, Sean Chan, Elisha Fulton, Anne Leditschke, Imogen Mitchell, Katrina Sowiak, Josie Russell-Brown, Helen Rodgers, Elise Taylor, Frank van Haren, Rachel Whyte, David Bowie, Alastair Gibson, Seton Henderson, Louise Hitchings, David Knight, Jan Mehrtens, Sascha Noble, David Sugden, Geoff Shaw, Winston Cheung, Peter Lawrence, David Milliss, Govindasamy Thanakrishnan, Helen Wong, Benno Ihle, Lavan Padayachee, Vasantha Pather, Megan Robertson, Sharon Allsop, John Botha, Kavi Haji, Kate Jones, David Blythe, Vivienne Butler, Bart De Keulenaer, Annamaria Palermo, Allison Bone, Claire Cattigan, Tania Elderkin, Melissa Fraser, Neil Orford, Tania Salerno, Miranda Hardie, Peter Harrigan, Anders Aneman, Amjed Aziz, Sharon Micallef, Sharyn Parker, Michael Parr, Tracy Parrish, Victor Tam, Benoj Varghese, John Morgan, Jeff Presneill, Joanne Sutton, Robyn Bond, Louise Cole, Cheryl Cuzner, Rebecca Gresham, Maria Nikas, Phoebe Palejs, Ian Seppelt, Leonie Weisbrodt, Sarah Whereat, Jeanette Bell, Annette Flanagan, Umit Holland, Ywain Lawrey, Janet Liang, Graeme Duke, John Green, Mary Park, Michael Reade, Jasmin Sungkar, Frances Bass, David Bihari, Pam Edhouse, Maryam Sana, Yahya Shehabi, Alison Walker, Rob Boots, Renae Deans, Rachel Dunlop, Paul Jarrett, Melissa Lassig-Smith, Jeffrey Lipman, Therese Starr, Janine Stuart, Lisa Wang, Allan Beswick, David Cooper, Rick McAllister, David Rigg, Andrew Turner, Frances Bass, Simon Bird, Celia Bradford, Anthony Delaney, Simon Finfer, Carol Foote, Roger Harris, Naomi Hammond, Richard Lee, Lewis Macken, Grainne McEvoy, Anne O'Connor, Julie Potter, Raymond Raper, Elizabeth Steel, Elizabeth Yarad, Heidi Buhr, Jodie Cowell, Mark Daley, David Gattas, Spoorthi Gowda, Robert Herkes, Robert Hislop, Liarna Honeysett, Heike Koelzow, Mark Lucey, Michael O'Leary, Paul Phipps, Dorrilyn Rajbhandari, Caitlin Rees, Richard Totaro, Clive Woolfe, Deb Inskip, Jennene Miller, John Myburgh, Manoj Saxena, Rebecca Sidoli, Jennifer Holmes, John Santamaria, Roger Smith, Antony Tobin, Troy Browne, Denise Bryers, Jennifer Goodson, James Houghton, Shirley Nelson, John Durning, Annette Forrest, Mary La Pine, Geoffrey McCracken, Helen Terlesk, Frank van Haren, Lynn Andrews, Ben Barry, Richard Dinsdale, Helen Golds, Peter Hicks, Diane Mackle, Jessica Ongley, Tania Phillips, Chris Poynter, Alex Psirides, Shawn Sturland, Robert Ure, Bronwyn Williams, Paul Young, Amy Partanen, Ranald Pascoe, Brenda Rosser, Amanda Stanton, Ashley Trehane, Bala Venkatesh, Samantha Bates, Jenie Butler, Lyndal Keen, Forbes McGain, Anna Tippett, Ashoke Banerjee, Peter Clark, Jing Kong, Maridy Morrison, Vineet Nayyar, Christina Skelly, Edward Stachowski, Rinaldo Bellomo, Alan Cass, Arina Dan, Simon Finfer, David Gattas, Parisa Glass, Naomi Hammond, Stephen Jan, Bette Liu, Stephen MacMahon, John Myburgh, Robyn Norton, Vlado Perkovic, Colman Taylor, Maryam Correa, Donna Goldsmith, Ann Gould, Dijlah Hannah, Meg Harward, Louise Ham, Julie Harland, Joanne Lee, Ashleigh Myburgh, Maryanne Ng, Dorrilyn Rajbhandari, Suzie Ryan, Kelly Thompson, Bala Vijayan, Lynsey Willenberg, Laurent Billot, Severine Bompoint, Stephane Heritier, Qiang Li, Jayanthi Mysore, Ross Bidencope, Joanne Cole, Richard Fisher, Dan Kramer, Tim Regan, Jean-Francois Baron, Frank Bepperling, Thomas Gottwald, Martin Holler, Cornelius Jungheinrich, Hrishikesh Kulkarni, Marc Maltas, Bernard Ott, Martin Westphal, Geoff Godfrey, David Marando, Sue Miles, Andrew Minton, Jeremy Simpson

Abstract

Background: The safety and efficacy of hydroxyethyl starch (HES) for fluid resuscitation have not been fully evaluated, and adverse effects of HES on survival and renal function have been reported.

Methods: We randomly assigned 7000 patients who had been admitted to an intensive care unit (ICU) in a 1:1 ratio to receive either 6% HES with a molecular weight of 130 kD and a molar substitution ratio of 0.4 (130/0.4, Voluven) in 0.9% sodium chloride or 0.9% sodium chloride (saline) for all fluid resuscitation until ICU discharge, death, or 90 days after randomization. The primary outcome was death within 90 days. Secondary outcomes included acute kidney injury and failure and treatment with renal-replacement therapy.

Results: A total of 597 of 3315 patients (18.0%) in the HES group and 566 of 3336 (17.0%) in the saline group died (relative risk in the HES group, 1.06; 95% confidence interval [CI], 0.96 to 1.18; P=0.26). There was no significant difference in mortality in six predefined subgroups. Renal-replacement therapy was used in 235 of 3352 patients (7.0%) in the HES group and 196 of 3375 (5.8%) in the saline group (relative risk, 1.21; 95% CI, 1.00 to 1.45; P=0.04). In the HES and saline groups, renal injury occurred in 34.6% and 38.0% of patients, respectively (P=0.005), and renal failure occurred in 10.4% and 9.2% of patients, respectively (P=0.12). HES was associated with significantly more adverse events (5.3% vs. 2.8%, P<0.001).

Conclusions: In patients in the ICU, there was no significant difference in 90-day mortality between patients resuscitated with 6% HES (130/0.4) or saline. However, more patients who received resuscitation with HES were treated with renal-replacement therapy. (Funded by the National Health and Medical Research Council of Australia and others; CHEST ClinicalTrials.gov number, NCT00935168.).

Source: PubMed

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