Randomized Controlled Trial

. 2019 Jun;47(6):765-773.

doi: 10.1097/CCM.0000000000003762.

Quality of Life and 1-Year Survival in Patients With Early Septic Shock: Long-Term Follow-Up of the Australasian Resuscitation in Sepsis Evaluation Trial

Alisa M Higgins¹, Sandra L Peake^{1

2}, Rinaldo Bellomo^{1

3}, D Jamie Cooper^{1

4}, Anthony Delaney^{1

5}, Anthony H Harris⁶, Belinda D Howe¹, Alistair D Nichol^{1

4

7}, Steve A Webb^{1

8}, Patricia J Williams^{1

2}; Australasian Resuscitation in Sepsis Evaluation (ARISE) Investigators and the ANZICS Clinical Trials Group

Collaborators, Affiliations

Collaborators

Australasian Resuscitation in Sepsis Evaluation (ARISE) Investigators and the ANZICS Clinical Trials Group:
A M Higgins, S Peake, R Bellomo, A Delaney, D J Cooper, A Harris, B D Howe, S A R Webb, P Williams, P A Cameron, A Cross, C Gomersall, C Graham, A Holdgate, I Jacobs, S Johanson, P Jones, P Kruger, C McArthur, J Myburgh, A Nichol, V Pettilä, D Rajbhandari, A Williams, J Williams, C Baigent, B Cuthbertson, J Benger, J Emberson, M Bailey, G Bives, A Jovanovska, L Lam, L Little, L Newby, V Bennett, J Board, P McCracken, S McGloughlin, V Nanjayya, E Hill, E O’Brien, F Sawtell, K Schimanski, D Wilson, S Bolch, G Eastwood, F Kerr, L Peak, H Young, J Edington, J Fletcher, J Smith, D Ghelani, K Nand, T Sara, D Flemming, M Grummisch, A Purdue, E Fulton, K Grove, A Harney, K Milburn, R Millar, I Mitchell, H Rodgers, S Scanlon, T Coles, H Connor, J Dennett, A Van Berke, S Barrington-Onslow, S Henderson, J Mehrtens, J Dryburgh, A Tankel, G Braitberg, B O’Bree, K Shepherd, S Vij, S Allsop, D Haji, K Haji, J Vuat, A Bone, T Elderkin, N Orford, M Ragg, S Kelly, D Stewart, N Woodward, V P Harjola, M Okkonen, V Pettilä, S Sutinen, E Wilkman, J Fratzia, J Halkhoree, S Treloar, K Ryan, T Sandford, J Walsham, C Jenkins, D Williamson, J Burrows, D Hawkins, C Tang, A Dimakis, A Holdgate, S Micallef, M Parr, H White, L Morrison, K Sosnowski, R Ramadoss, N Soar, J Wood, M Franks, A Williams, C Hogan, R Song, A Tilsley, D Rainsford, R Wells, J Dowling, P Galt, T Lamac, D Lightfoot, C Walker, K Braid, T DeVillecourt, H S Tan, I Seppelt, L F Chang, W S Cheung, S K Fok, P K Lam, S M Lam, H M So, W W Yan, A Altea, B Lancashire, C D Gomersall, C A Graham, P Leung, S Arora, F Bass, Y Shehabi, J Isoardi, K Isoardi, D Powrie, S Lawrence, A Ankor, L Chester, M Davies, S O’Connor, A Poole, T Soulsby, K Sundararajan, J H Greenslade, C MacIsaac, K Gorman, A Jordan, L Moore, S Ankers, S Bird, A Delaney, J Dowling, T Fogg, E Hickson, T Jewell, K Kyneur, A O’Connor, J Townsend, E Yarad, S Brown, J Chamberlain, J Cooper, E Jenkinson, E McDonald, S Webb, H Buhr, J Coakley, J Cowell, D Hutch, D Gattas, M Keir, D Rajbhandari, C Rees, S Baker, B Roberts, E Farone, J Holmes, J Santamaria, C Winter, A Finckh, S Knowles, J McCabe, P Nair, C Reynolds, B Ahmed, D Barton, E Meaney, A Nichol, R Harris, L Shields, K Thomas, S Karlsson, A Kuitunen, A Kukkurainen, J Tenhunen, S Varila, J Burrows, N Ryan, C Trethewy, J Crosdale, J C Smith, M Vellaichamy, J Furyk, G Gordon, L Jones, S Senthuran, S Bates, J Butler, C French, A Tippett, J Kelly, J Kwans, M Murphy, D O’Flynn, C Kurenda, T Otto, S Peake, V Raniga, H F Ho, A Leung, H Wu

Affiliations

¹ Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
² Department of Intensive Care Medicine, The Queen Elizabeth Hospital, University of Adelaide, Adelaide, SA, Australia.
³ Department of Intensive Care, Austin Health, Melbourne, VIC, Australia.
⁴ Department of Intensive Care and Hyperbaric Medicine, The Alfred, Melbourne, VIC, Australia.
⁵ Department of Intensive Care, Royal North Shore Hospital and University of Sydney, Sydney, NSW, Australia.
⁶ Centre for Health Economics, Monash University, Melbourne, VIC, Australia.
⁷ School of Medicine and Medical Sciences, University College Dublin, Dublin, Ireland.
⁸ Department of Intensive Care, Royal Perth Hospital and University of Western Australia, Perth, WA, Australia.

PMID: 30985391
DOI: 10.1097/CCM.0000000000003762

Randomized Controlled Trial

Quality of Life and 1-Year Survival in Patients With Early Septic Shock: Long-Term Follow-Up of the Australasian Resuscitation in Sepsis Evaluation Trial

Alisa M Higgins et al. Crit Care Med. 2019 Jun.

. 2019 Jun;47(6):765-773.

doi: 10.1097/CCM.0000000000003762.

Authors

Collaborators

Australasian Resuscitation in Sepsis Evaluation (ARISE) Investigators and the ANZICS Clinical Trials Group:
A M Higgins, S Peake, R Bellomo, A Delaney, D J Cooper, A Harris, B D Howe, S A R Webb, P Williams, P A Cameron, A Cross, C Gomersall, C Graham, A Holdgate, I Jacobs, S Johanson, P Jones, P Kruger, C McArthur, J Myburgh, A Nichol, V Pettilä, D Rajbhandari, A Williams, J Williams, C Baigent, B Cuthbertson, J Benger, J Emberson, M Bailey, G Bives, A Jovanovska, L Lam, L Little, L Newby, V Bennett, J Board, P McCracken, S McGloughlin, V Nanjayya, E Hill, E O’Brien, F Sawtell, K Schimanski, D Wilson, S Bolch, G Eastwood, F Kerr, L Peak, H Young, J Edington, J Fletcher, J Smith, D Ghelani, K Nand, T Sara, D Flemming, M Grummisch, A Purdue, E Fulton, K Grove, A Harney, K Milburn, R Millar, I Mitchell, H Rodgers, S Scanlon, T Coles, H Connor, J Dennett, A Van Berke, S Barrington-Onslow, S Henderson, J Mehrtens, J Dryburgh, A Tankel, G Braitberg, B O’Bree, K Shepherd, S Vij, S Allsop, D Haji, K Haji, J Vuat, A Bone, T Elderkin, N Orford, M Ragg, S Kelly, D Stewart, N Woodward, V P Harjola, M Okkonen, V Pettilä, S Sutinen, E Wilkman, J Fratzia, J Halkhoree, S Treloar, K Ryan, T Sandford, J Walsham, C Jenkins, D Williamson, J Burrows, D Hawkins, C Tang, A Dimakis, A Holdgate, S Micallef, M Parr, H White, L Morrison, K Sosnowski, R Ramadoss, N Soar, J Wood, M Franks, A Williams, C Hogan, R Song, A Tilsley, D Rainsford, R Wells, J Dowling, P Galt, T Lamac, D Lightfoot, C Walker, K Braid, T DeVillecourt, H S Tan, I Seppelt, L F Chang, W S Cheung, S K Fok, P K Lam, S M Lam, H M So, W W Yan, A Altea, B Lancashire, C D Gomersall, C A Graham, P Leung, S Arora, F Bass, Y Shehabi, J Isoardi, K Isoardi, D Powrie, S Lawrence, A Ankor, L Chester, M Davies, S O’Connor, A Poole, T Soulsby, K Sundararajan, J H Greenslade, C MacIsaac, K Gorman, A Jordan, L Moore, S Ankers, S Bird, A Delaney, J Dowling, T Fogg, E Hickson, T Jewell, K Kyneur, A O’Connor, J Townsend, E Yarad, S Brown, J Chamberlain, J Cooper, E Jenkinson, E McDonald, S Webb, H Buhr, J Coakley, J Cowell, D Hutch, D Gattas, M Keir, D Rajbhandari, C Rees, S Baker, B Roberts, E Farone, J Holmes, J Santamaria, C Winter, A Finckh, S Knowles, J McCabe, P Nair, C Reynolds, B Ahmed, D Barton, E Meaney, A Nichol, R Harris, L Shields, K Thomas, S Karlsson, A Kuitunen, A Kukkurainen, J Tenhunen, S Varila, J Burrows, N Ryan, C Trethewy, J Crosdale, J C Smith, M Vellaichamy, J Furyk, G Gordon, L Jones, S Senthuran, S Bates, J Butler, C French, A Tippett, J Kelly, J Kwans, M Murphy, D O’Flynn, C Kurenda, T Otto, S Peake, V Raniga, H F Ho, A Leung, H Wu

Affiliations

¹ Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
² Department of Intensive Care Medicine, The Queen Elizabeth Hospital, University of Adelaide, Adelaide, SA, Australia.
³ Department of Intensive Care, Austin Health, Melbourne, VIC, Australia.
⁴ Department of Intensive Care and Hyperbaric Medicine, The Alfred, Melbourne, VIC, Australia.
⁵ Department of Intensive Care, Royal North Shore Hospital and University of Sydney, Sydney, NSW, Australia.
⁶ Centre for Health Economics, Monash University, Melbourne, VIC, Australia.
⁷ School of Medicine and Medical Sciences, University College Dublin, Dublin, Ireland.
⁸ Department of Intensive Care, Royal Perth Hospital and University of Western Australia, Perth, WA, Australia.

PMID: 30985391
DOI: 10.1097/CCM.0000000000003762

Abstract

Objectives: To examine long-term survival and quality of life of patients with early septic shock.

Design: Prospective, randomized, parallel-group trial.

Setting: Fifty-one hospitals in Australia, New Zealand, Finland, Hong Kong, and the Republic of Ireland.

Patients: One-thousand five-hundred ninety-one patients who presented to the emergency department with early septic shock between October 2008 and April 2014, and were enrolled in the Australasian Resuscitation in Sepsis Evaluation trial.

Interventions: Early goal-directed therapy versus usual care.

Measurements and main results: Long-term survival was measured up to 12 months postrandomization. Health-related quality of life was measured using the EuroQoL-5D-3L, Short Form 36 and Assessment of Quality of Life 4D at baseline, and at 6 and 12 months following randomization. Mortality data were available for 1,548 patients (97.3%) and 1,515 patients (95.2%) at 6 and 12 months, respectively. Health-related quality of life data were available for 85.1% of survivors at 12 months. There were no significant differences in mortality between groups at either 6 months (early goal-directed therapy 21.8% vs usual care 22.6%; p = 0.70) or 12 months (early goal-directed therapy 26.4% vs usual care 27.9%; p = 0.50). There were no group differences in health-related quality of life at either 6 or 12 months (EuroQoL-5D-3L utility scores at 12 mo early goal-directed therapy 0.65 ± 0.33 vs usual care 0.64 ± 0.34; p = 0.50), with the health-related quality of life of both groups being significantly lower than population norms.

Conclusions: In patients presenting to the emergency department with early septic shock, early goal-directed therapy compared with usual care did not reduce mortality nor improve health-related quality of life at either 6 or 12 months.

Trial registration: ClinicalTrials.gov NCT00975793.

PubMed Disclaimer

Publication types

Actions
Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Associated data

Actions
- Search in PubMed
- Search in ClinicalTrials.gov

LinkOut - more resources

Full Text Sources
- Ovid Technologies, Inc.
- Wolters Kluwer
Medical
- ClinicalTrials.gov
Miscellaneous
- NCI CPTAC Assay Portal

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Quality of Life and 1-Year Survival in Patients With Early Septic Shock: Long-Term Follow-Up of the Australasian Resuscitation in Sepsis Evaluation Trial

Collaborators

Affiliations

Quality of Life and 1-Year Survival in Patients With Early Septic Shock: Long-Term Follow-Up of the Australasian Resuscitation in Sepsis Evaluation Trial

Authors

Collaborators

Affiliations

Abstract

Publication types

MeSH terms

Associated data

LinkOut - more resources

Full Text Sources

Medical

Miscellaneous