RESUMEN
Objective: To describe the relative importance of health concerns reported by survivors of critical illness treated in the intensive care unit (ICU), their estimate of time to achieve recovery, and their reported randomised clinical trial participation willingness. Design: A multicentre survey. Setting: Six Australian ICUs. Participants: Adult patients who had received mechanical ventilation, vasopressor support or renal replacement therapy for more than 24 h were likely to be discharged from ICU within 24 h. Interventions: Survey administration was verbal and occurred in the ICU. Main outcome measures: A numeric rating of eight ICU survivor-related health concerns developed with consumer input (disability requiring ongoing care, prolonged hospitalisation, repeated hospitalisation, impaired activity level, pain, low mood, inability to return home, and dying). Zero indicated no concern and ten extreme concern. Respondents were also asked to estimate their expected recovery time and their willingness to participate in a randomised clinical trial. Results: Of 584 eligible participants, 286 (49.0%) respondents had a mean age of 62.3 years (standard deviation (SD) 14.8) and 178 (62.2%) were male. The median ICU length of stay at the time of survey was 4 days (interquartile range (IQR) 3-7). Respondents reported high levels of concern for all health outcomes with the highest median scores being for survival with severe disability and requirement for ongoing care scoring 8 (IQR 3-10), and never being able to return home needing assisted living or a nursing home scoring 8 (IQR 1-10). The median expected recovery time was 23 days (IQR 10-33). Higher concerns were associated with an increased likelihood of trial participation willingness. Conclusion: Survivors reported high and varied health concerns of which severe disability requiring care and inability to return home were the highest. Respondents anticipated a relatively short recovery.
RESUMEN
Objective: To determine the feasibility of a pivotal randomised clinical trial of intravenous (IV) iron and erythropoietin in adult survivors of critical illness with anaemia requiring treatment in the intensive care unit. Design: An investigator-initiated, parallel group, placebo-controlled, randomised feasibility trial. Setting: A tertiary intensive care unit (ICU) in Perth, Western Australia. Participants: Adults with anaemia (haemoglobin <100 g/L), requiring ICU-level care for more than 48 h, and likely to be ready for ICU discharge within 24 h. Interventions: A single dose of IV ferric carboxymaltose and Epoetin alfa (active group) or an equal volume of 0.9% saline (placebo group). Main outcome measures: Study feasibility was considered met if the pilot achieved a recruitment rate of ≥2 participants per site per month, ≥90% of participants received their allocated study treatment, and≥ 90% of participants were followed up for the proposed pivotal trial primary outcome - days alive and at home to day 90 (DAH90). Results: The 40-participant planned sample size included twenty in each group and was enrolled between 1/9/2021 and 2/3/2022. Participants spent a median of 3.4 days (interquartile range 2.8-5.1) in the ICU prior to enrolment and had a mean baseline haemoglobin of 83.7 g/L (standard deviation 6.7). The recruitment rate was 6.7 participants per month [95% confidence interval (CI) 4.8-9.0], DAH90 follow-up was 100% (95% CI 91.2%-100%), and 39 (97.5%, 95% CI 86.8%-99.9%) participants received the allocated study intervention. No serious adverse events were reported. Conclusion: The iron and erythropoietin to heal and recover after intensive care (ITHRIVE) pilot demonstrated feasibility based on predefined participant recruitment, study drug administration, and follow-up thresholds.