Dataset Information

Lower versus higher oxygenation targets in ICU patients with haematological malignancy - insights from the HOT-ICU trial.

ABSTRACT:

Background

Patients admitted to an intensive care unit (ICU) with active haematological malignancy and hypoxaemic respiratory failure have a high mortality. Oxygen supplementation is essential, but limited information exists on the optimum oxygenation targets in these patients.

Methods

This subgroup analysis was specified before completion of the Handling Oxygenation Targets in the ICU (HOT-ICU) trial. The trial investigated the effects of a lower (8 kPa) vs a higher (12 kPa) arterial oxygenation target and was stratified for active haematological malignancy, chronic obstructive pulmonary disease, and site. We here report the primary outcome (90-day mortality) and selected secondary outcomes in the subgroup of patients with active haematological malignancy.

Results

The HOT-ICU trial included 168 patients with active haematological malignancy; 82 were randomly allocated to an arterial oxygenation target of 8 kPa, and 86 to 12 kPa. At 90 days, 53/81 patients (65%) in the lower-oxygenation group and 47/86 patients (55%) in the higher-oxygenation group had died: adjusted relative risk 1.22 (95% confidence interval 0.95-1.56); at 1 year, the numbers were 58/81 (72%) vs 56/86 (65%): adjusted relative risk 1.11 (95% confidence interval 0.90-1.36). No statistically significant differences were found for any secondary outcomes.

Conclusion

In ICU patients with active haematological malignancies and hypoxaemic respiratory failure, we found a high mortality at 90 days and 1 year. Our results did not preclude clinically relevant benefits or harms of a lower oxygenation target in patients with active haematological malignancy. A randomised trial may, therefore, be worthwhile for these patients.

Clinical trial registration

NCT03174002.

SUBMITTER: Klitgaard TL

PROVIDER: S-EPMC10430820 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Publications

Lower versus higher oxygenation targets in ICU patients with haematological malignancy - insights from the HOT-ICU trial.

Klitgaard Thomas L TL Schjørring Olav L OL Severinsen Marianne T MT Perner Anders A Rasmussen Bodil S BS

BJA open 20220923

<h4>Background</h4>Patients admitted to an intensive care unit (ICU) with active haematological malignancy and hypoxaemic respiratory failure have a high mortality. Oxygen supplementation is essential, but limited information exists on the optimum oxygenation targets in these patients.<h4>Methods</h4>This subgroup analysis was specified before completion of the Handling Oxygenation Targets in the ICU (HOT-ICU) trial. The trial investigated the effects of a lower (8 kPa) <i>vs</i> a higher (12 kP ...[more]

PMID: 37588787

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Project description:BackgroundOxygen therapy is a common treatment in the intensive care unit (ICU) with both potentially desirable and undesirable long-term effects. This systematic review aimed to assess the long-term outcomes of lower versus higher oxygenation strategies in adult ICU survivors.MethodsWe included randomised clinical trials (RCTs) comparing lower versus higher oxygen supplementation or oxygenation strategies in adults admitted to the ICU. We searched major electronic databases and trial registers. We included all non-mortality long-term outcomes. Prespecified co-primary outcomes were the long-term cognitive function measures, the overall score of any valid health-related quality of life (HRQoL) evaluation, standardised 6-min walk test, and lung diffusion capacity. The protocol was published and prospectively registered in the PROSPERO database (CRD42021223630).ResultsThe review included 17 RCTs comprising 6592 patients, and six trials with 825 randomised patients reported one or more outcomes of interest. We observed no difference in cognitive evaluation via Telephone Interview for Cognitive Status (one trial, 409 patients) (mean score: 30.6 ± 4.5 in the lower oxygenation group vs. 30.4 ± 4.3 in the higher oxygenation group). The trial was judged at overall high risk of bias and the certainty of evidence was very low. Any difference was neither observed in HRQoL measured via EuroQol 5 dimensions 5 level questionnaire and EQ Visual Analogue Score (one trial, 499 patients) (mean score: 70.1 ± 22 in the lower oxygenation group vs. 67.6 ± 22.4 in the higher oxygenation group). The trial was judged as having high risk of bias, the certainty of evidence was very low. No trial reported neither the standardised 6-min walk test nor lung diffusion test.ConclusionThe evidence is very uncertain about the effect of a lower versus a higher oxygenation strategy on both the cognitive function and HRQoL. A lower versus a higher oxygenation strategy may have a little to no effect on both outcomes but the certainty of evidence is very low. No evidence was found for the effects on the standardised 6-min walking test and diffusion capacity test.

Project description:ImportanceSupplemental oxygen is ubiquitously used in patients with COVID-19 and severe hypoxemia, but a lower dose may be beneficial.ObjectiveTo assess the effects of targeting a Pao2 of 60 mm Hg vs 90 mm Hg in patients with COVID-19 and severe hypoxemia in the intensive care unit (ICU).Design, setting, and participantsMulticenter randomized clinical trial including 726 adults with COVID-19 receiving at least 10 L/min of oxygen or mechanical ventilation in 11 ICUs in Europe from August 2020 to March 2023. The trial was prematurely stopped prior to outcome assessment due to slow enrollment. End of 90-day follow-up was June 1, 2023.InterventionsPatients were randomized 1:1 to a Pao2 of 60 mm Hg (lower oxygenation group; n = 365) or 90 mm Hg (higher oxygenation group; n = 361) for up to 90 days in the ICU.Main outcomes and measuresThe primary outcome was the number of days alive without life support (mechanical ventilation, circulatory support, or kidney replacement therapy) at 90 days. Secondary outcomes included mortality, proportion of patients with serious adverse events, and number of days alive and out of hospital, all at 90 days.ResultsOf 726 randomized patients, primary outcome data were available for 697 (351 in the lower oxygenation group and 346 in the higher oxygenation group). Median age was 66 years, and 495 patients (68%) were male. At 90 days, the median number of days alive without life support was 80.0 days (IQR, 9.0-89.0 days) in the lower oxygenation group and 72.0 days (IQR, 2.0-88.0 days) in the higher oxygenation group (P = .009 by van Elteren test; supplemental bootstrapped adjusted mean difference, 5.8 days [95% CI, 0.2-11.5 days]; P = .04). Mortality at 90 days was 30.2% in the lower oxygenation group and 34.7% in the higher oxygenation group (risk ratio, 0.86 [98.6% CI, 0.66-1.13]; P = .18). There were no statistically significant differences in proportion of patients with serious adverse events or in number of days alive and out of hospital.Conclusion and relevanceIn adult ICU patients with COVID-19 and severe hypoxemia, targeting a Pao2 of 60 mm Hg resulted in more days alive without life support in 90 days than targeting a Pao2 of 90 mm Hg.Trial registrationClinicalTrials.gov Identifier: NCT04425031.

Dataset Information

Lower versus higher oxygenation targets in ICU patients with haematological malignancy - insights from the HOT-ICU trial.

Background

Methods

Results

Conclusion

Clinical trial registration

Publications

Lower versus higher oxygenation targets in ICU patients with haematological malignancy - insights from the HOT-ICU trial.

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