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- DOI: 10.1001/jama.2014.5305
- PMID: 24842135
- UKPMCID: 24842135
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Effect of a perioperative, cardiac output-guided hemodynamic therapy algorithm on outcomes following major gastrointestinal surgery: a randomized clinical trial and systematic review.
Pearse, Rupert M; Harrison, David A; MacDonald, Neil; Gillies, Michael A; Blunt, Mark; Ackland, Gareth; Grocott, Michael P W; Ahern, Aoife; Griggs, Kathryn; Scott, Rachael; Hinds, Charles; Rowan, Kathryn
JAMA. 2014;311(21):2181-90.
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Full-text held externally
- DOI: 10.1001/jama.2014.5305
- PMID: 24842135
- UKPMCID: 24842135
Abstract
IMPORTANCE: Small trials suggest that postoperative outcomes may be improved by the use of cardiac output monitoring to guide administration of intravenous fluid and inotropic drugs as part of a hemodynamic therapy algorithm. OBJECTIVE: To evaluate the clinical effectiveness of a perioperative, cardiac output-guided hemodynamic therapy algorithm. DESIGN, SETTING, AND PARTICIPANTS: OPTIMISE was a pragmatic, multicenter, randomized, observer-blinded trial of 734 high-risk patients aged 50 years or older undergoing major gastrointestinal surgery at 17 acute care hospitals in the United Kingdom. An updated systematic review and meta-analysis were also conducted including randomized trials published from 1966 to February 2014. INTERVENTIONS: Patients were randomly assigned to a cardiac output-guided hemodynamic therapy algorithm for intravenous fluid and inotrope (dopexamine) infusion during and 6 hours following surgery (n=368) or to usual care (n=366). MAIN OUTCOMES AND MEASURES: The primary outcome was a composite of predefined 30-day moderate or major complications and mortality. Secondary outcomes were morbidity on day 7; infection, critical care-free days, and all-cause mortality at 30 days; all-cause mortality at 180 days; and length of hospital stay. RESULTS: Baseline patient characteristics, clinical care, and volumes of intravenous fluid were similar between groups. Care was nonadherent to the allocated treatment for less than 10% of patients in each group. The primary outcome occurred in 36.6% of intervention and 43.4% of usual care participants (relative risk [RR], 0.84 [95% CI, 0.71-1.01]; absolute risk reduction, 6.8% [95% CI, -0.3% to 13.9%]; P = .07). There was no significant difference between groups for any secondary outcomes. Five intervention patients (1.4%) experienced cardiovascular serious adverse events within 24 hours compared with none in the usual care group. Findings of the meta-analysis of 38 trials, including data from this study, suggest that the intervention is associated with fewer complications (intervention, 488/1548 [31.5%] vs control, 614/1476 [41.6%]; RR, 0.77 [95% CI, 0.71-0.83]) and a nonsignificant reduction in hospital, 28-day, or 30-day mortality (intervention, 159/3215 deaths [4.9%] vs control, 206/3160 deaths [6.5%]; RR, 0.82 [95% CI, 0.67-1.01]) and mortality at longest follow-up (intervention, 267/3215 deaths [8.3%] vs control, 327/3160 deaths [10.3%]; RR, 0.86 [95% CI, 0.74-1.00]). CONCLUSIONS AND RELEVANCE: In a randomized trial of high-risk patients undergoing major gastrointestinal surgery, use of a cardiac output-guided hemodynamic therapy algorithm compared with usual care did not reduce a composite outcome of complications and 30-day mortality. However, inclusion of these data in an updated meta-analysis indicates that the intervention was associated with a reduction in complication rates. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN04386758.
Bibliographic metadata
- MacDonald, Neil
- Parnell, Wendy
- Niebrzegowska, Edyta
- Bodger, Phoebe
- Gallego, Laura
- McAlees, Eleanor
- Januszewska, Marta
- Smith, Amanda
- Pearse, Rupert
- Gillies, Michael
- Antonelli, Jean
- Beattie, Craig
- McCulloch, Corienne
- Young, Neil
- Cameron, David
- McKeown, Dermot
- Walsh, Timothy
- Wilson, Elizabeth
- Hope, David
- Hay, Alasdair
- Beatty, Monika
- Parks, Rowan
- Blunt, Mark
- Young, Peter
- Moondi, Parvez
- Gibson, John
- Carter, Joseph
- Watson, Beverley
- Hobbinger, Helen
- Abdy, Sue
- Pretorius, Robert
- Shafeek, Sherif
- Wong, Kate
- Gent, Emma
- Wolf, Rebecca
- Wijewardena, Gayathri
- Young, Ben
- Irvine, Michael
- Steel, Alistair
- Elliot, Stuart
- Griffiths, Karen
- Beardow, Zoe
- Breen, Andrew
- Howell, Simon
- Birch, Sian
- Berridge, John
- Ackland, Gareth
- Gallego, Laura
- Reyes, Anna
- Stephens, Rob
- Mohr, Otto
- Reynolds, Toby
- Fawcett, Erik
- Baytug, Beki
- Hester, Natalie
- Sothisrihari, Saranga
- Cronin, James
- Mullenheim, Jost
- Clarkson, Rachel
- Dark, Paul
- Kershaw, Melanie
- Stubbs, Clare
- Walsh, Angela
- Baldwin, Jackie
- Owen, Tom
- Rice, Leslie
- Tricklebank, Stephen
- Smith, John
- Lei, Katie
- Sanderson, Barnaby
- Pearce, Adrian
- Ostermann, Marlies
- Wan, Ruth
- McKenzie, Cathy
- Berry, William
- Kirk-Bayley, Justin
- Clements, Debbie
- Dickinson, Matt
- Shankar, Shiny
- Carvalho, Peter
- Kelliher, Lee
- Jones, Chris
- Maddison, Ben
- Wright, Chris
- McNeela, Fiona
- Swan, Karen
- Topliffe, Joanne
- Williams, Sarah
- Smolen, Sue
- Kunst, Gudrun
- Parsons, Georgina
- Dunsire, Fraser
- Wade-Smith, Fiona
- Hadfield, Daniel
- Cottam, Simon
- Pittman, James
- Johnston, Darryl
- Potter, Alison
- Hutchings, Melanie
- Grice, Alex
- Daugherty, Mark
- Hellewell, Alastair
- Moppett, Iain
- Chikhani, Marc
- Evley, Rachel
- Bolger, Clare
- Piper, Jess
- Jonas, Max
- Linford, Karen
- Peach, Jennifer
- Redman, Jonathan
- Milner, Helen
- Taylor, Gail
- Wilson, Jonathan
- Yates, David
- Coats, Tim
- Pearse, Rupert
- Hinds, Charles
- Rowan, Kathryn
- Harrison, David
- Bennett, David
- Bellingan, Geoff
- Lobo, Dileep
- Hinton, Lisa
- Pearse, Rupert
- Rowan, Kathryn
- Ahern, Aoife
- Corlett, Sarah
- Scott, Rachael
- Harvey, Sheila
- Tan, Jermaine
- Harrison, David
- Griggs, Kathryn
- Grocott, Michael
- Pearse, Rupert
- Ahmad, Tahania
- Rowan, Kathryn
- Harrison, David
- Pearse, Rupert
- Hinds, Charles
- Bennett, David
- Beale, Richard
- Boyd, Owen
- Rowan, Kathryn
- Harrison, David
- Gates, Simon
- McAuley, Danny
- Treasure, Tom