No abstract

OBJECTIVES: Although the current coronavirus disease 2019 pandemic demonstrates the urgent need for the integration of tele-ICUs, there is still a lack of uniform regulations regarding the level of authority. We conducted a systematic review and meta-analysis to evaluate the impact of the level of authority in tele-ICU care on patient outcomes. DATA SOURCES: We searched MEDLINE, EMBASE, CENTRAL, and Web of Science from inception until August 30, 2020. STUDY SELECTION: We searched for randomized controlled trials and observational studies comparing standard care plus tele-ICU care with standard care alone in critically ill patients. DATA EXTRACTION: Two authors performed data extraction and risk of bias assessment. Mean differences and risk ratios were calculated using a random-effects model. DATA SYNTHESIS: A total of 20 studies with 477,637 patients (n tele-ICU care = 292,319, n control = 185,318) were included. Although “decision-making authority” as the level of authority was associated with a significant reduction in ICU mortality (pooled risk ratio, 0.82; 95% CI, 0.71–0.94; p = 0.006), we found no advantage of tele-ICU care in studies with “expert tele-consultation” as the level of authority. With regard to length of stay, “decision-making authority” resulted in an advantage of tele-ICU care (ICU length of stay: pooled mean difference, –0.78; 95% CI, –1.46 to –0.10; p = 0.14; hospital length of stay: pooled mean difference, –1.54; 95% CI, –3.13 to 0.05; p = 0.06), whereas “expert tele-consultation” resulted in an advantage of standard care (ICU length of stay: pooled mean difference, 0.31; 95% CI, 0.10–0.53; p = 0.005; hospital length of stay: pooled mean difference, 0.58; 95% CI, –0.04 to 1.21; p = 0.07). CONCLUSIONS: In contrast to expert tele-consultations, decision-making authority during tele-ICU care reduces mortality and length of stay in the ICU. This work confirms the urgent need for evidence-based ICU telemedicine guidelines and reveals potential benefits of uniform regulations regarding the level of authority when providing tele-ICU care.

Ivabradine as adjuvant treatment for chronic heart failure (Review)

Background Peritonitis is responsible for thousands of deaths annually in Germany alone. Even source control (SC) and antibiotic treatment often fail to prevent severe sepsis or septic shock, and this situation has hardly improved in the past two decades. Most experimental immunomodulatory therapeutics for sepsis have been aimed at blocking or dampening a specific pro-inflammatory immunological mediator. However, the patient collective is large and heterogeneous. There are therefore grounds for investigating the possibility of developing personalized therapies by classifying patients into groups according to biomarkers. This study aims to combine an assessment of the efficacy of treatment with a preparation of human immunoglobulins G, A, and M (IgGAM) with individual status of various biomarkers (immunoglobulin level, procalcitonin, interleukin 6, antigen D-related human leucocyte antigen (HLA-DR), transcription factor NF-κB1, adrenomedullin, and pathogen spectrum). Methods/design A total of 200 patients with sepsis or septic shock will receive standard-of-care treatment (SoC). Of these, 133 patients (selected by 1:2 randomization) will in addition receive infusions of IgGAM for 5 days. All patients will be followed for approximately 90 days and assessed by the multiple-organ failure (MOF) score, by the EQ QLQ 5D quality-of-life scale, and by measurement of vital signs, biomarkers (as above), and survival. Discussion This study is intended to provide further information on the efficacy and safety of treatment with IgGAM and to offer the possibility of correlating these with the biomarkers to be studied. Specifically, it will test (at a descriptive level) the hypothesis that patients receiving IgGAM who have higher inflammation status (IL-6) and poorer immune status (low HLA-DR, low immunoglobulin levels) have a better outcome than patients who do not receive IgGAM. It is expected to provide information that will help to close the knowledge gap concerning the association between the effect of IgGAM and the presence of various biomarkers, thus possibly opening the way to a personalized medicine. Trial registration EudraCT, 2016–001788-34; ClinicalTrials.gov, NCT03334006 . Registered on 17 Nov 2017. Trial sponsor: RWTH Aachen University, represented by the Center for Translational & Clinical Research Aachen (contact Dr. S. Isfort). Electronic supplementary material The online version of this article (10.1186/s13063-019-3244-4) contains supplementary material, which is available to authorized users.