A long-term follow-up study investigating health-related quality of life and resource use in survivors of severe sepsis: comparison of recombinant human activated protein C with standard care.
BACKGROUND
Recombinant human activated protein C (APC) therapy has been shown to reduce short-term mortality in patients with severe sepsis. However, survivors of sepsis may have long-term complications affecting health-related quality of life (HRQoL) and resource utilization. The objective of this study was to evaluate prospectively the effect of APC on long-term HRQoL and resource utilization compared with a nonrandomized control group that received standard care.


METHODS
This was an observational cohort study at nine Canadian intensive care units. Patients with severe sepsis who survived to 28 days were recruited. Patients who received APC formed the treatment group and those that did not formed the standard care group. Patients who did not receive APC because of central nervous system bleeding risk were excluded from the standard care group. HRQoL (determined using the 36-item Short Form) and resource use were recorded at 28 days, and 3, 5 and 7 months.


RESULTS
One hundred patients were enrolled (64 in the standard care group and 36 in the APC group), with 70 patients completing all follow-up visits. Over the 6 months of follow up, APC-treated patients exhibited statistically significantly better scores for the physical component score (P = 0.04) and trends toward improvements in physical functioning (P = 0.12), role physical (P = 0.10) and bodily pain (P = 0.14) as compared with standard care patients. Shorter hospital length of stay was observed for the APC group (36 days versus 48 days; P = 0.05).


CONCLUSIONS
These findings challenge earlier assumptions suggesting equivalent HRQoL and resource use in APC-treated and standard care patients who survive severe sepsis.
Longo
Christopher J
CJ
McMaster University, Main Street West, Hamilton, Ontario, Canada, L8S 4M4. cjlongo@mcmaster.ca
Heyland
Daren K
DK
Fisher
Harold N
HN
Fowler
Robert A
RA
Martin
Claudio M
CM
Day
Andrew G
AG
D000328:Adult; D000368:Aged; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D010342:Patient Acceptance of Health Care; D011486:Protein C / Q000627:therapeutic use*; D011788:Quality of Life; D011994:Recombinant Proteins / Q000627:therapeutic use*; D018805:Sepsis / Q000401:mortality / Q000628:therapy*; D015996:Survival Rate / Q000639:trends
D011486:Protein C; D011994:Recombinant Proteins; C421124:drotrecogin alfa activated