ProMISe: Protocolised Management In Sepsis

Background

Sepsis is a severe infection in the blood which can damage important organs in the body, such as the heart and lungs. Patients who develop sepsis are at a high risk of dying. A research study in a US hospital emergency department found that patients with sepsis treated using a 6-hour resuscitation protocol (compared with usual treatment) were more likely to survive and to spend less time in hospital. The ProMISe study wanted to find out if the 6-hour resuscitation protocol would work in the UK, compared with usual treatment.

Design

A total of 1260 patients from 56 hospitals across the country took part in the study. Patients were evenly split into two groups to receive either the 6-hour resuscitation protocol or usual treatment. They were followed up for 1 year to see the long-term effects of receiving treatment.

Results

There was no significant difference in the number of patients who died after 90 days or after 1 year of receiving either treatment. The costs of treatment (in hospital and after leaving hospital) were higher for patients who received the 6-hour resuscitation protocol.

Conclusion

The 6-hour resuscitation protocol did not improve survival for patients with sepsis and was more expensive.

Who led the study?

Professor Kathy Rowan, ICNARC

This study was funded by the National Institute for Health Research (NIHR) – Health Technology Assessment (HTA) Programme (Project: 07/37/47)

Publications

Rowan KM, Angus DC, Bailey M, Barnato AE, Bellomo R, Canter R, Coats TJ, Delaney A, Gimbel E, Grieve RD, Harrison DA, Higgins AH, Howe B, Huang DT, Kellum JA, Mouncey PR, Music E, Peake SL, Pike F, Reade MC, Sadique MZ, Singer M, Yealy DM. Early, Goal-Directed Therapy for Septic Shock - A Patient-Level Meta-Analysis. N Engl J Med 2017; . http://dx.doi.org/10.1056/NEJMoa1701380

Mouncey PR, Osborn TM, Power GS, Harrison DA, Sadique MZ, Grieve RD, Jahan R, Tan JC, Harvey SE, Bell D, Bion JF, Coats TJ, Singer M, Young JD, Rowan KM. Protocolised Management In Sepsis (ProMISe): a multicentre randomised controlled trial of the clinical effectiveness and cost-effectiveness of early, goal-directed, protocolised resuscitation for emerging septic shock. Health Technol Assess 2015; 19(97):1-150. http://dx.doi.org/10.3310/hta19970

Mouncey PR, Osborn TM, Power GS, Harrison DA, Sadique MZ, Grieve RD, Jahan R, Harvey SE, Bell D, Bion JF, Coats TJ, Singer M, Young JD, Rowan KM. Trial of early, goal-directed resuscitation for septic shock. N Engl J Med 2015; 372(14):1301-11. http://dx.doi.org/10.1056/NEJMoa1500896

Angus DC, Barnato AE, Bell D, Bellomo R, Chong CR, Coats TJ, Davies A, Delaney A, Harrison DA, Holdgate A, Howe B, Huang DT, Iwashyna T, Kellum JA, Peake SL, Pike F, Reade MC, Rowan KM, Singer M, Webb SA, Weissfeld LA, Yealy DM, Young JD. A systematic review and meta-analysis of early goal-directed therapy for septic shock: the ARISE, ProCESS and ProMISe Investigators. Intensive Care Med 2015; 41(9):1549-60. http://dx.doi.org/10.1007/s00134-015-3822-1

Power GS, Harrison DA, Mouncey PR, Osborn TM, Harvey SE, Rowan KM. The Protocolised Management in Sepsis (ProMISe) trial statistical analysis plan. Crit Care Resusc 2013; 15(4):311-7.

Huang DT, Angus DC, Barnato A, Gunn SR, Kellum JA, Stapleton DK, Weissfeld LA, Yealy DM, Peake SL, Delaney A, Bellomo R, Cameron P, Higgins A, Holdgate A, Howe B, Webb SA, Williams P, Osborn TM, Mouncey PR, Harrison DA, Harvey SE, Rowan KM. Harmonizing international trials of early goal-directed resuscitation for severe sepsis and septic shock: methodology of ProCESS, ARISE, and ProMISe. Intensive Care Med 2013; 39(10):1760-75. http://dx.doi.org/10.1007/s00134-013-3024-7

Reade MC, Delaney A, Bailey MJ, Harrison DA, Yealy DM, Jones PG, Rowan KM, Bellomo R, Angus DC. Prospective meta-analysis using individual patient data in intensive care medicine. Intensive Care Med 2010; 36(1):11-21. http://dx.doi.org/10.1007/s00134-009-1650-x

Delaney A, Angus DC, Bellomo R, Cameron P, Cooper DJ, Finfer S, Harrison DA, Huang DT, Myburgh JA, Peake SL, Reade MC, Webb SA, Yealy DM. Bench-to-bedside review: the evaluation of complex interventions in critical care. Crit Care 2008; 12(2):210. http://dx.doi.org/10.1186/cc6849

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