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PurposePatients receiving venoarterial extracorporeal membrane oxygenation (VA-ECMO) frequently develop arterial hyperoxaemia, which may be harmful. However, lower oxygen saturation targets may also lead to harmful episodes of hypoxaemia.MethodsIn this registry-embedded, multicentre trial, we randomly assigned adult patients receiving VA-ECMO in an intensive care unit (ICU) to either a conservative (target SaO2 92–96%) or to a liberal oxygen strategy (target SaO2 97–100%) through controlled oxygen administration via the ventilator and ECMO gas blender. The primary outcome was the number of ICU-free days to day 28. Secondary outcomes included ICU-free days to day 60, mortality, ECMO and ventilation duration, ICU and hospital lengths of stay, and functional outcomes at 6 months.ResultsFrom September 2019 through June 2023, 934 patients who received VA-ECMO were reported to the EXCEL registry, of whom 300 (192 cardiogenic shock, 108 refractory cardiac arrest) were recruited. We randomised 149 to a conservative and 151 to a liberal oxygen strategy. The median number of ICU-free days to day 28 was similar in both groups (conservative: 0 days [interquartile range (IQR) 0–13.7] versus liberal: 0 days [IQR 0–13.3], median treatment effect: 0 days [95% confidence interval (CI) – 3.1 to 3.1]). Mortality at day 28 (59/149 [39.6%] vs 59/151 [39.1%]) and at day 60 (64/149 [43%] vs 62/151 [41.1%] were similar in conservative and liberal groups, as were all other secondary outcomes and adverse events. The conservative group experienced 44 (29.5%) major protocol deviations compared to 2 (1.3%) in the liberal oxygen group (P < 0.001).ConclusionsIn adults receiving VA-ECMO in ICU, a conservative compared to a liberal oxygen strategy, did not affect the number of ICU-free days to day 28.

Background Nutrition interventions commenced in ICU and continued through to hospital discharge have not been definitively tested in critical care to date. To commence a program of research, we aimed to determine if a tailored nutrition intervention delivered for the duration of hospitalisation delivers more energy than usual care to patients initially admitted to the Intensive Care Unit (ICU). Methods A multicentre, unblinded, parallel-group, phase II trial was conducted in twenty-two hospitals in Australia and New Zealand. Adult patients, requiring invasive mechanical ventilation (MV) for 72–120 h within ICU, and receiving < 80% estimated energy requirements from enteral nutrition (EN) were included. The intervention (tailored nutrition) commenced in ICU and included EN and supplemental parenteral nutrition (PN), and EN, PN, and/or oral nutrition after liberation from MV, and was continued until hospital discharge or study day 28. The primary outcome was daily energy delivery from nutrition (kcal). Secondary outcomes included duration of hospital stay, ventilator free days at day 28 and total blood stream infection rate. Main results The modified intention to treat analysis included 237 patients (n = 119 intervention and n = 118 usual care). Baseline characteristics were balanced; the median [interquartile range] intervention period was 19 [14–35] and 19 [13–32] days in the tailored nutrition and usual care groups respectively. Energy delivery was 1796 ± 31 kcal/day (tailored nutrition) versus 1482 ± 32 kcal/day (usual care)—adjusted mean difference 271 kcal/day, 95% CI 189–354 kcal. No differences were observed in any secondary outcomes. Conclusions A tailored nutrition intervention commenced in the ICU and continued until hospital discharge achieved a significant increase in energy delivery over the duration of hospitalisation for patients initially admitted to the ICU. Trial registration ClinicalTrials.gov Identifier NCT03292237 . First registered 25th September 2017. Last updated 10th Feb 2023.

PurposeTo investigate the impact of hydrocortisone treatment and illness severity on health-related quality of life (HRQoL) at 6 months in septic shock survivors from the ADRENAL trial.MethodsUsing the EuroQol questionnaire (EQ-5D-5L) at 6 months after randomization we assessed HRQoL in patient subgroups defined by hydrocortisone or placebo treatment, gender, illness severity (APACHE II < or ≥ 25), and severity of shock (baseline peak catecholamine doses < or ≥ 15 mcg/min). Additionally, in subgroups defined by post-randomisation variables; time to shock reversal (days), treatment with renal replacement therapy (RRT), and presence of bacteremia.ResultsAt 6 months, there were 2521 survivors. Of these 2151 patients (85.3%-1080 hydrocortisone and 1071 placebo) completed 6-month follow-up. Overall, at 6 months the mean EQ-5D-5L visual analogue scale (VAS) was 70.8, mean utility score 59.4. Between 15% and 30% of patients reported moderate to severe problems in any given HRQoL domain. There were no differences in any EQ-5D-5L domain in patients who received hydrocortisone vs. placebo, nor in the mean VAS (p = 0.6161), or mean utility score (p = 0.7611). In all patients combined, males experienced lower pain levels compared to females [p = 0.0002). Neither higher severity of illness or shock impacted reported HRQoL. In post-randomisation subgroups, longer time to shock reversal was associated with increased problems with mobility (p = < 0.0001]; self-care (p = 0.0.0142), usual activities (p = <0.0001] and pain (p = 0.0384). Amongst those treated with RRT, more patients reported increased problems with mobility (p = 0.0307) and usual activities (p = 0.0048) compared to those not treated. Bacteraemia was not associated with worse HRQoL in any domains of the EQ-5D-5L.ConclusionsApproximately one fifth of septic shock survivors report moderate to extreme problems in HRQoL domains at 6 months. Hydrocortisone treatment for septic shock was not associated with improved HRQoL at 6 months. Female gender was associated with worse pain at 6 months.

Background The optimal transfusion threshold for patients undergoing venoarterial extracorporeal membrane oxygenation (VA-ECMO) remains uncertain. Methods We used data from OBLEX (ClinicalTrials.gov: NCT03714048), an international, prospective, observational study conducted across 12 centres in Australia, Europe, and North America between 2019 and 2022. The study collected information on patient demographics, bleeding risk factors, transfusion practices during the first seven days of ECMO, and in-hospital mortality. Using these data, we emulated a target trial comparing the effects of liberal transfusion practice (transfusion initiated at Hb ≥ 90 g/L) and restrictive transfusion practice (transfusion initiated at Hb ≤ 70 g/L) on hospital mortality within seven days of ECMO initiation. Sequential trials approach was used to estimate the causal contrast. Results A total of 534 patients were included, with 46% dying during hospitalisation. After accounting for potential confounders, the liberal transfusion practice demonstrated a modest survival benefit within the first two days of ECMO, with differences in survival probabilities of 12% (95% CI 3% to 21%) at day 2 and 13% (95% CI 2% to 25%) at day 3, corresponding to the number needed to treat (NNT) of 8 and 7 respectively. No differences in survival benefit were found after day 3. These results were consistent across sensitivity and exploratory analyses. Conclusion This target trial emulation study suggests that a liberal transfusion threshold may provide a modest survival benefit during the early course of VA-ECMO, but no benefit afterwards. Prospective studies are needed to confirm these findings, assess clinical adoption, and investigate underlying mechanism.