Treating the Most Critically Ill Patients With COVID-19

MacLaren, Graeme; Fisher, Dale; Brodie, Daniel

doi:10.1001/jama.2021.22580

Cited by 27 publications

(10 citation statements)

References 9 publications

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“…It should be noted that 29 of the 31 patients were treated with vvECMO therapy for COVID-19 related respiratory failure. Our patient cohort may differ from non-COVID vvECMO patients with regard to the haemodynamic state and the need for vasopressor therapy 31 . Our results may thus not be generalizable to patients treated with vvECMO for respiratory failure of different aetiology.…”

Section: Discussionmentioning

confidence: 71%

“…Our patient cohort may differ from non-COVID vvECMO patients with regard to the haemodynamic state and the need for vasopressor therapy. 31 Our results may thus not be generalizable to patients treated with vvECMO for respiratory failure of different aetiology. However, it seems reasonable to assume that the measurement performance of PRAM-CO would be similar in other vvECMO populations.…”

Section: Discussionmentioning

confidence: 75%

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Agreement between cardiac output measurements by pulse wave analysis using the Pressure Recording Analytical Method and transthoracic echocardiography in patients with veno-venous extracorporeal membrane oxygenation therapy

Greiwe

Flick

Hapfelmeier

et al. 2023

European Journal of Anaesthesiology

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BACKGROUNDMeasuring cardiac output (CO) is important in patients treated with veno-venous extracorporeal membrane oxygenation (vvECMO) because vvECMO flow and CO need to be balanced. Uncalibrated pulse wave analysis with the Pressure Recording Analytical Method (PRAM) may be suitable to measure CO in patients with vvECMO therapy.OBJECTIVETo assess the agreement between CO measured by PRAM (PRAM-CO; test method) and CO measured by transthoracic echocardiography (TTE-CO; reference method).DESIGNA prospective observational method comparison study.SETTINGThe ICU of a German university hospital between March and December 2021.PATIENTSThirty one adult patients with respiratory failure requiring vvECMO therapy: 29 of the 31 patients (94%) were treated for COVID-19 related respiratory failure.MAIN OUTCOME MEASURESPRAM-CO and TTE-CO were measured simultaneously at two time points in each patient with at least 20 min between measurements. A radial or femoral arterial catheter-derived blood pressure waveform was used for PRAM-CO measurements. TTE-CO measurements were conducted using the pulsed wave Doppler-derived velocity time integral of the left ventricular outflow tract (LVOT) and the corresponding LVOT diameter. PRAM-CO and TTE-CO were compared using Bland–Altman analysis and the percentage error (PE). We defined a PE of <30% as clinically acceptable.RESULTSMean ± SD PRAM-CO was 6.86 ± 1.49 l min−1 and mean TTE-CO was 6.94 ± 1.58 l min−1. The mean of the differences between PRAM-CO and TTE-CO was 0.09 ± 0.73 l min−1 with a lower 95% limit of agreement of −1.34 l min−1 and an upper 95% limit of agreement of 1.51 l min−1. The PE was 21%.CONCLUSIONSThe agreement between PRAM-CO and TTE-CO is clinically acceptable in adult patients with vvECMO therapy.

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Section: Discussionmentioning

confidence: 71%

Section: Discussionmentioning

confidence: 75%

Agreement between cardiac output measurements by pulse wave analysis using the Pressure Recording Analytical Method and transthoracic echocardiography in patients with veno-venous extracorporeal membrane oxygenation therapy

Greiwe

Flick

Hapfelmeier

et al. 2023

European Journal of Anaesthesiology

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“…Second, stopping of adaptive trials without pre-specified sample sizes was considered early stopping; so was reaching sample sizes that had been changed after trial initiation. 43,44 Third, the BOX and REMAP-CAP trials were included three [45][46][47] and six [48][49][50][51][52][53] times, respectively, because they yielded the same numbers of principal reports with distinct foci.…”

Section: Deviations From the Protocol And Post-hoc Design Decisionsmentioning

confidence: 99%

“…Thirty-eight trials (15% of 246 trials, see 'Deviations from protocol' above) used some kind of predictive enrichment, and despite some clear-cut examples, 57,58 most were not. REMAP-CAP, for example, excluded anticoagulated patients from domains studying anticoagulation 48,53 and immunocompromised patients from the steroid domain. 50…”

Section: Secondary-data Causal Evidence For Predictive Enrichmentmentioning

confidence: 99%

Real‐world causal evidence for planned predictive enrichment in critical care trials: A scoping review

Kaas‐Hansen,

Granholm,

Sivapalan

et al. 2023

Acta Anaesthesiol Scand

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BackgroundRandomised clinical trials in critical care are prone to inconclusiveness due, in part, to undue optimism about effect sizes and suboptimal accounting for heterogeneous treatment effects. Although causal evidence from rich real‐world critical care can help overcome these challenges by informing predictive enrichment, no overview exists.MethodsWe conducted a scoping review, systematically searching 10 general and speciality journals for reports published on or after 1 January 2018, of randomised clinical trials enrolling adult critically ill patients. We collected trial metadata on 22 variables including recruitment period, intervention type and early stopping (including reasons) as well as data on the use of causal evidence from secondary data for planned predictive enrichment.ResultsWe screened 9020 records and included 316 unique RCTs with a total of 268,563 randomised participants. One hundred seventy‐three (55%) trials tested drug interventions, 101 (32%) management strategies and 42 (13%) devices. The median duration of enrolment was 2.2 (IQR: 1.3–3.4) years, and 83% of trials randomised less than 1000 participants. Thirty‐six trials (11%) were restricted to COVID‐19 patients. Of the 55 (17%) trials that stopped early, 23 (42%) used predefined rules; futility, slow enrolment and safety concerns were the commonest stopping reasons. None of the included RCTs had used causal evidence from secondary data for planned predictive enrichment.ConclusionWork is needed to harness the rich multiverse of critical care data and establish its utility in critical care RCTs. Such work will likely need to leverage methodology from interventional and analytical epidemiology as well as data science.

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“…COVID-19 has had an enormous effect on healthcare resources worldwide, leading to the mass resignation of healthcare workers in some regions. As parts of the world now labor under new waves of multiple respiratory viruses, including new variants of COVID-19, it is imperative that the pediatric intensive care community continue to work collaboratively to meet the needs of critically ill children in their region and continually reexamine the role of ECMO in children with COVID-19 in order to provide rational and equitable care (14,15).…”

mentioning

confidence: 99%

Outcomes After Extracorporeal Membrane Oxygenation in Children With COVID-19*

MacLaren

Barbaro

Nardo³

2023

Pediatric Critical Care Medicine

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A s the COVID-19 pandemic spread across the globe, it became rapidly apparent that elderly patients were at the greatest risk of death and the young seemed inherently protected (1). However, as successive waves hit large population centers, the initial impression that children could not be seriously affected by the disease became untenable, particularly for those with preexisting health problems. COVID-19 can cause pediatric acute respiratory distress syndrome (PARDS), myocarditis, or multisystem inflammatory syndrome in children (MIS-C) (2, 3). Clinicians have employed extracorporeal membrane oxygenation (ECMO) support in the most severe cases, but the precise indications and treatment effect remain unclear.ECMO has been used far more extensively in adults than children throughout the pandemic, yet only very recently has evidence emerged that ECMO may confer a survival advantage in selected adult patients with COVID-19 (4-6). Outcomes have also changed over time as different treatments, viral variants, and vaccination have evolved (7,8). The evidence supporting the use of ECMO in non-neonatal children with respiratory failure of any cause is not particularly well established, let alone in those with COVID-19 (9). Consequently, physicians consider initiating ECMO for PARDS refractory to standard management when the risks of life-threatening hypoxemia, ventilator-induced lung injury, respiratory acidosis, and multiple organ failure are judged to be higher than the risks of bleeding, thrombosis, and other potential complications related to ECMO. Wide practice variations thus exist among centers regarding patient selection and more evidence on when to start ECMO, the risk factors for mortality, and general outcome data are needed.In this issue of Pediatric Critical Care Medicine, Watanabe et al (10) addressed some of these gaps by conducting a systematic review of 44 studies of 110 children supported on ECMO for COVID-19. Overall mortality was 27%. Of note, mortality appeared higher in children with MIS-C than with PARDS, even though the majority (82%) of children with MIS-C were previously healthy. While the study by Watanabe et al (10) was not designed to evaluate any potential survival benefit of ECMO over conventional therapy in pediatric COVID-19 patients or to assess when to initiate ECMO, several important details can be gleaned, nonetheless. First, ECMO survival of patients with PARDS from COVID-19 was higher than that of patients with PARDS from other causes, although this may have been affected by publication bias and other confounders. Second, survival in children was higher and complication rates were generally lower than those of adults receiving ECMO for . Third, the use of both corticosteroids *See also p. 406.

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Treating the Most Critically Ill Patients With COVID-19

Cited by 27 publications

References 9 publications

Agreement between cardiac output measurements by pulse wave analysis using the Pressure Recording Analytical Method and transthoracic echocardiography in patients with veno-venous extracorporeal membrane oxygenation therapy

Agreement between cardiac output measurements by pulse wave analysis using the Pressure Recording Analytical Method and transthoracic echocardiography in patients with veno-venous extracorporeal membrane oxygenation therapy

Real‐world causal evidence for planned predictive enrichment in critical care trials: A scoping review

Outcomes After Extracorporeal Membrane Oxygenation in Children With COVID-19*

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