Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery
Paul S Myles, Rinaldo Bellomo, Tomas Corcoran, Andrew Forbes, Philip Peyton, David Story, Chris Christophi, Kate Leslie, Shay McGuinness, Rachael Parke, Jonathan Serpell, Matthew T V Chan, Thomas Painter, Stuart McCluskey, Gary Minto, Sophie Wallace, Australian and New Zealand College of Anaesthetists Clinical Trials Network and the Australian and New Zealand Intensive Care Society Clinical Trials Group, M Mythen, R Gruen, J McNeil, G Ludbrook, K Lee, A Meehan, D McIlroy, M Shulman, D J Cooper, C Farrington, A Ditoro, W Galagher, M Pollock, A Neylan, S Sidiropoulos, S Baulch, A Carter, S Jacups, J L Reynolds, J Rowley, A J Neal, E J Bendall, J R Sutherland, R Bulach, A Wang, N L T Tan, C Osborne, A Marriott, K Ives, B Wakefield, A Quail, J Douglas, I Boden, D Blackford, A Chuan, I Seppelt, A Wu, B Rodriguez, L Siu, R Robinson, L Bulfin, A A Beck, V Wilkinson, B Riedel, A Melville, U Gurunathan, M Bennett, A Duggan, P Sivalingam, B Moser, T Bott, S Sawhney, M Duroux, M Chapman, J Moore, S Lang, J Hayer, R Koronis, N Terblanche, D Cooper, R Turner, R Seale, M Challis, K Gard, R Cotter, T D Phan, P Corcoran, Y Uda, V Nguyen, D Bramley, A M Southcott, J Grant, H Taylor, S Bates, M Towns, A Tippett, F Marshall, J van Vlymen, M Jaeger, D DuMerton Shore, H Sato, T Sato, V Chan, R Jin, N Ayach, M T V Chan, P W Y Chiu, W W K Wu, M Tsang, G Landoni, R Lembo, F Pugh, D McAllister, P Dalley, S Reddy, E Ridgeon, S Hurford, L Navarra, R Sol Cruz, S Harwood, A Patrick, A Pai, A Kaliappan, M Vertue, J Sonksen, R Gidda, A Chishti, C Scott, S Jakkampudi, P Watt, Z Milan, S Birch, G Kunst, D Martin, S James, M Pinto, R C F Sinclair, A Addei, S Cope, H Melsom, L Duncan, A Kurz, D Sessler, S Miller, M Brawley, K O Pryor, S C Marcott, L A Pharmer, Paul S Myles, Rinaldo Bellomo, Tomas Corcoran, Andrew Forbes, Philip Peyton, David Story, Chris Christophi, Kate Leslie, Shay McGuinness, Rachael Parke, Jonathan Serpell, Matthew T V Chan, Thomas Painter, Stuart McCluskey, Gary Minto, Sophie Wallace, Australian and New Zealand College of Anaesthetists Clinical Trials Network and the Australian and New Zealand Intensive Care Society Clinical Trials Group, M Mythen, R Gruen, J McNeil, G Ludbrook, K Lee, A Meehan, D McIlroy, M Shulman, D J Cooper, C Farrington, A Ditoro, W Galagher, M Pollock, A Neylan, S Sidiropoulos, S Baulch, A Carter, S Jacups, J L Reynolds, J Rowley, A J Neal, E J Bendall, J R Sutherland, R Bulach, A Wang, N L T Tan, C Osborne, A Marriott, K Ives, B Wakefield, A Quail, J Douglas, I Boden, D Blackford, A Chuan, I Seppelt, A Wu, B Rodriguez, L Siu, R Robinson, L Bulfin, A A Beck, V Wilkinson, B Riedel, A Melville, U Gurunathan, M Bennett, A Duggan, P Sivalingam, B Moser, T Bott, S Sawhney, M Duroux, M Chapman, J Moore, S Lang, J Hayer, R Koronis, N Terblanche, D Cooper, R Turner, R Seale, M Challis, K Gard, R Cotter, T D Phan, P Corcoran, Y Uda, V Nguyen, D Bramley, A M Southcott, J Grant, H Taylor, S Bates, M Towns, A Tippett, F Marshall, J van Vlymen, M Jaeger, D DuMerton Shore, H Sato, T Sato, V Chan, R Jin, N Ayach, M T V Chan, P W Y Chiu, W W K Wu, M Tsang, G Landoni, R Lembo, F Pugh, D McAllister, P Dalley, S Reddy, E Ridgeon, S Hurford, L Navarra, R Sol Cruz, S Harwood, A Patrick, A Pai, A Kaliappan, M Vertue, J Sonksen, R Gidda, A Chishti, C Scott, S Jakkampudi, P Watt, Z Milan, S Birch, G Kunst, D Martin, S James, M Pinto, R C F Sinclair, A Addei, S Cope, H Melsom, L Duncan, A Kurz, D Sessler, S Miller, M Brawley, K O Pryor, S C Marcott, L A Pharmer
Abstract
Background: Guidelines to promote the early recovery of patients undergoing major surgery recommend a restrictive intravenous-fluid strategy for abdominal surgery. However, the supporting evidence is limited, and there is concern about impaired organ perfusion.
Methods: In a pragmatic, international trial, we randomly assigned 3000 patients who had an increased risk of complications while undergoing major abdominal surgery to receive a restrictive or liberal intravenous-fluid regimen during and up to 24 hours after surgery. The primary outcome was disability-free survival at 1 year. Key secondary outcomes were acute kidney injury at 30 days, renal-replacement therapy at 90 days, and a composite of septic complications, surgical-site infection, or death.
Results: During and up to 24 hours after surgery, 1490 patients in the restrictive fluid group had a median intravenous-fluid intake of 3.7 liters (interquartile range, 2.9 to 4.9), as compared with 6.1 liters (interquartile range, 5.0 to 7.4) in 1493 patients in the liberal fluid group (P<0.001). The rate of disability-free survival at 1 year was 81.9% in the restrictive fluid group and 82.3% in the liberal fluid group (hazard ratio for death or disability, 1.05; 95% confidence interval, 0.88 to 1.24; P=0.61). The rate of acute kidney injury was 8.6% in the restrictive fluid group and 5.0% in the liberal fluid group (P<0.001). The rate of septic complications or death was 21.8% in the restrictive fluid group and 19.8% in the liberal fluid group (P=0.19); rates of surgical-site infection (16.5% vs. 13.6%, P=0.02) and renal-replacement therapy (0.9% vs. 0.3%, P=0.048) were higher in the restrictive fluid group, but the between-group difference was not significant after adjustment for multiple testing.
Conclusions: Among patients at increased risk for complications during major abdominal surgery, a restrictive fluid regimen was not associated with a higher rate of disability-free survival than a liberal fluid regimen and was associated with a higher rate of acute kidney injury. (Funded by the Australian National Health and Medical Research Council and others; RELIEF ClinicalTrials.gov number, NCT01424150 .).
Source: PubMed