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1.
Article in English | MEDLINE | ID: mdl-38581102

ABSTRACT

BACKGROUND: Proton pump inhibitors (PPIs) are the most commonly prescribed drugs for preventing upper gastrointestinal bleeding in critically ill patients. However, concerns have arisen about the possible harms of using PPIs, including potentially increased risk of pneumonia, Clostridioides difficile infection, and more seriously, an increased risk of death in the most severely ill patients. Triggered by the REVISE trial, which is a forthcoming large randomized trial comparing pantoprazole to placebo in invasively mechanically ventilated patients, we will conduct this systematic review to evaluate the efficacy and safety of PPIs versus no prophylaxis for critically ill patients. METHODS: We will systematically search randomized trials that compared gastrointestinal bleeding prophylaxis with PPIs versus placebo or no prophylaxis in adults in the intensive care unit (ICU). Pairs of reviewers will independently screen the literature, and for those eligible trials, extract data and assess risk of bias. We will perform meta-analyses using a random-effects model, and calculate relative risks for dichotomous outcomes and mean differences for continuous outcomes, and the associated 95% confidence intervals. We will conduct subgroup analysis to explore whether the impact of PPIs on mortality differs in more and less severely ill patients. We will assess certainty of evidence using the GRADE approach. DISCUSSION: This systematic review will provide the most up-to-date evidence regarding the merits and limitations of stress ulcer prophylaxis with PPIs in critically ill patients in contemporary practice.

2.
Acta Anaesthesiol Scand ; 68(4): 579-581, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38317635

ABSTRACT

BACKGROUND: Risk prediction models are used for many purposes in emergency surgery, including critical care triage and benchmarking. Several risk prediction models have been developed, and some are used for purposes other than those for which they were developed. We aim to provide an overview of the existing literature on risk prediction models used in emergency surgery and highlight knowledge gaps. METHODS: We will conduct a scoping review on risk prediction models used for patients undergoing emergency surgery in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). We will search Medline, EMBASE, and the Cochrane Library and include all study designs. We aim to answer the following questions: (1) What risk prediction models are used in emergency surgery? (2) Which variables are used in these models? (3) Which surgical specialties are the models used for? (4) Have the models been externally validated? (5) Where have the models been externally validated? (6) What purposes were the models developed for? (7) What are the strengths and limitations of the included models? We will summarize the results descriptively. The certainty of evidence will be evaluated using a modified Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. CONCLUSION: The outlined scoping review will summarize the existing literature on risk prediction models used in emergency surgery and highlight knowledge gaps.


Subject(s)
Benchmarking , Critical Care , Humans , Research Design , Triage , Systematic Reviews as Topic , Review Literature as Topic
3.
Acta Anaesthesiol Scand ; 67(10): 1383-1394, 2023 Nov.
Article in English | MEDLINE | ID: mdl-37737652

ABSTRACT

BACKGROUND: When caring for mechanically ventilated adults with acute hypoxaemic respiratory failure (AHRF), clinicians are faced with an uncertain choice between ventilator modes allowing for spontaneous breaths or ventilation fully controlled by the ventilator. The preferences of clinicians managing such patients, and what motivates their choice of ventilator mode, are largely unknown. To better understand how clinicians' preferences may impact the choice of ventilatory support for patients with AHRF, we issued a survey to an international network of intensive care unit (ICU) researchers. METHODS: We distributed an online survey with 32 broadly similar and interlinked questions on how clinicians prioritise spontaneous or controlled ventilation in invasively ventilated patients with AHRF of different severity, and which factors determine their choice. RESULTS: The survey was distributed to 1337 recipients in 12 countries. Of these, 415 (31%) completed the survey either fully (52%) or partially (48%). Most respondents were identified as medical specialists (87%) or physicians in training (11%). Modes allowing for spontaneous ventilation were considered preferable in mild AHRF, with controlled ventilation considered as progressively more important in moderate and severe AHRF. Among respondents there was strong support (90%) for a randomised clinical trial comparing spontaneous with controlled ventilation in patients with moderate AHRF. CONCLUSIONS: The responses from this international survey suggest that there is clinical equipoise for the preferred ventilator mode in patients with AHRF of moderate severity. We found strong support for a randomised trial comparing modes of ventilation in patients with moderate AHRF.


Subject(s)
Respiratory Insufficiency , Adult , Humans , Respiratory Insufficiency/therapy , Respiration, Artificial , Lung , Intensive Care Units , Respiration
4.
Acta Anaesthesiol Scand ; 67(9): 1194-1201, 2023 10.
Article in English | MEDLINE | ID: mdl-37353882

ABSTRACT

Risk prediction models are frequently used to identify high-risk patients undergoing emergency laparotomy. The National Emergency Laparotomy Audit (NELA) developed a risk prediction model specifically for emergency laparotomy patients, which was recently updated. In this study, we validated the updated NELA model in an external population. Furthermore, we compared it with three other risk prediction models: the original NELA model, the Portsmouth Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity (P-POSSUM) model, and the American Society of Anesthesiologists Physical Status (ASA-PS). We included adult patients undergoing emergency laparotomy at Zealand University Hospital, from March 2017 to January 2019, and Herlev Hospital, from November 2017 to January 2020. Variables included in the risk prediction models were collected retrospectively from the electronic patient records. Discrimination of the risk prediction models was evaluated with area under the curve (AUC) statistics, and calibration was assessed with Cox calibration regression. The primary outcome was 30-day mortality. Out of 1226 included patients, 146 patients (11.9%) died within 30 days. AUC (95% confidence interval) for 30-day mortality was 0.85 (0.82-0.88) for the updated NELA model, 0.84 (0.81-0.87) for the original NELA model, 0.81 (0.77-0.84) for the P-POSSUM model, and 0.76 (0.72-0.79) for the ASA-PS model. Calibration showed underestimation of mortality risk for both the updated NELA, original NELA and P-POSSUM models. The updated NELA risk prediction model performs well in this external validation study and may be used in similar settings. However, the model should only be used to discriminate between low- and high-risk patients, and not for prediction of individual risk due to underestimation of mortality.


Subject(s)
Laparotomy , Adult , Humans , Laparotomy/adverse effects , Retrospective Studies , Risk Assessment , Morbidity
5.
Chest ; 164(4): 892-912, 2023 Oct.
Article in English | MEDLINE | ID: mdl-37142091

ABSTRACT

BACKGROUND: IV fluids are recommended for adults with sepsis. However, the optimal strategy for IV fluid management in sepsis is unknown, and clinical equipoise exists. RESEARCH QUESTION: Do lower vs higher fluid volumes improve patient-important outcomes in adult patients with sepsis? STUDY DESIGN AND METHODS: We updated a systematic review with meta-analysis and trial sequential analysis of randomized clinical trials assessing lower vs higher IV fluid volumes in adult patients with sepsis. The coprimary outcomes were all-cause mortality, serious adverse events, and health-related quality of life. We followed the recommendations from the Cochrane Handbook and used the Grading of Recommendations Assessment, Development and Evaluation approach. Primary conclusions were based on trials with low risk of bias if available. RESULTS: We included 13 trials (N = 4,006) with four trials (n = 3,385) added to this update. The meta-analysis of all-cause mortality in eight trials with low risk of bias showed a relative risk of 0.99 (97% CI, 0.89-1.10; moderate certainty evidence). Six trials with predefined definitions of serious adverse events showed a relative risk of 0.95 (97% CI, 0.83-1.07; low certainty evidence). Health-related quality of life was not reported. INTERPRETATION: Among adult patients with sepsis, lower IV fluid volumes probably result in little to no difference in all-cause mortality compared with higher IV fluid volumes, but the interpretation is limited by imprecision in the estimate, which does not exclude potential benefit or harm. Similarly, the evidence suggests lower IV fluid volumes result in little to no difference in serious adverse events. No trials reported on health-related quality of life. TRIAL REGISTRATION: PROSPERO; No.: CRD42022312572; URL: https://www.crd.york.ac.uk/prospero/.

6.
Acta Anaesthesiol Scand ; 67(7): 925-935, 2023 08.
Article in English | MEDLINE | ID: mdl-37078441

ABSTRACT

BACKGROUND: Abnormal serum levels of magnesium, phosphate, and zinc appear common in intensive care unit (ICU) patients, but the epidemiology, management, and associations with outcomes are less well described. We described these factors and estimated associations with outcomes in a large dataset of Danish ICU patients. METHODS: We included adults who were acutely admitted to 10 general ICUs in Denmark between October 2011 and January 2018. From the dataset, we obtained characteristics of patients who had serum levels measured of magnesium, phosphate, or zinc, including data on supplementation. We used joint models with death as a competing outcome to estimate the associations between abnormal serum levels and time to successful extubation and, for magnesium, also incident tachyarrhythmia. RESULTS: We included 16,517 of 36,514 patients in the dataset. The cumulative probability of hypomagnesemia within 28 days was 64% (95% confidence interval [CI] 62-66); of hypophosphatemia 74% (95% CI 72-75); and of hypozincemia 98% (95% CI 98-98). Supplementation of magnesium was used in 3554 out of 13,506 (26%) patients, phosphate in 2115 out of 14,148 (15%) patients, and zinc in 4465 out of 9869 (45%) patients. During ICU stay, 38% experienced hypermagnesemia, 58% hyperphosphatemia, and 1% hyperzincemia. Low serum levels of magnesium, phosphate, and zinc were associated with shorter time to successful extubation, and high serum magnesium and phosphate and low serum zinc with the competing risk of increased mortality, but too few serum measurements made the results inconclusive. CONCLUSION: In this multicenter cohort study of acutely admitted ICU patients, most experienced low serum levels of magnesium, phosphate, or zinc during ICU stay, many received supplementation, and experiencing both low and high serum levels during ICU stay was not uncommon. Associations between serum levels and clinical outcomes appeared inconclusive because the data proved unfit for these analyses.


Subject(s)
Magnesium , Malnutrition , Adult , Humans , Cohort Studies , Phosphates , Zinc , Critical Illness , Intensive Care Units
7.
Crit Care Med ; 51(6): 717-730, 2023 06 01.
Article in English | MEDLINE | ID: mdl-36951465

ABSTRACT

OBJECTIVES: We aimed to provide an overview of the current evidence on routine versus on-demand blood sampling in critical care. We assessed the reported proportion of patients exposed to daily routine blood sampling, the tests performed, characteristics associated with more frequent blood sampling, and the reported benefits and harms of routine blood sampling compared with on-demand sampling. DATA SOURCES: We systematically searched the Cochrane Library, the Excerpta Medica Database, and the Medical Literature Analysis and Retrieval System Online for studies assessing routine versus on-demand blood testing in critically ill patients from inception to September 2022. STUDY SELECTION: Abstracts and full texts were assessed independently and in duplicate by two reviewers. STUDY EXTRACTION: Data were extracted independently and in duplicate by two reviewers using predefined extraction forms. DATA SYNTHESIS: Of 12,212 records screened, 298 full-text articles were assessed for eligibility. We included 70 studies; 50 nonrandomized interventional studies and 20 observational studies. Exposure to routine blood testing was 52-100% (very low certainty of evidence). Blood testing seemed to occur more frequently in medical intensive care settings with a median of 18 blood tests per patient day (interquartile range, 10-33) (very low certainty of evidence). Mixed biochemistry seemed to be the most frequently performed blood tests across all settings (five tests per patient day; interquartile range, 2-10) (very low certainty of evidence). Reductions in routine blood testing seemed to be associated with reduced transfusion rates and costs without apparent adverse patient outcomes (low certainty of evidence). CONCLUSIONS: In this systematic review, routine blood testing in critically ill patients was common and varied considerably. A reduction in routine blood testing appeared to be associated with reduced transfusion rates and costs without adverse effects, but the evidence was very uncertain.


Subject(s)
Critical Care , Critical Illness , Humans , Patients , Blood Transfusion
8.
Acta Anaesthesiol Scand ; 67(3): 264-276, 2023 03.
Article in English | MEDLINE | ID: mdl-36562170

ABSTRACT

BACKGROUND: Low-serum levels of magnesium, phosphate, and zinc are observed in many intensive care unit (ICU) patients, but clinical equipoise exists regarding supplementation strategies. We aimed to assess the desirable and undesirable effects of supplementation with magnesium, phosphate, or zinc in adult ICU patients. METHODS: We conducted a systematic review with meta-analysis of randomised clinical trials assessing the effects of supplementation with magnesium, phosphate, or zinc in adult ICU patients. Primary outcomes were mortality and duration of mechanical ventilation. We registered the protocol, followed the Preferred Reporting Items for Systematic Review and Meta-Analysis statement, used the Cochrane risk of bias 2 tool, and the grading of recommendations, assessment, development and evaluation (GRADE) approach for assessing the certainty of the evidence. RESULTS: We identified no low risk of bias trials. For magnesium supplementation, we included three trials (n = 235); the relative risk (RR) for mortality was 0.54, 95% confidence interval (CI) 0.30-0.96 compared to no supplementation (very low certainty of evidence). For zinc supplementation, two trials were included (n = 168); the RR for mortality was 0.73, 95% CI 0.41-1.28 compared to control. No trials assessed the effects of phosphate supplementation on mortality. For outcomes other than mortality, only zero or one trial was available. CONCLUSIONS: In adult ICU patients, the certainty of evidence for the effects of supplementation with magnesium, phosphate, or zinc was very low. High-quality trials are needed to assess the value of supplementation strategies in these patients.


Subject(s)
Magnesium , Zinc , Adult , Humans , Zinc/therapeutic use , Phosphates , Critical Care , Intensive Care Units
9.
Crit Care Med ; 50(10): e759-e771, 2022 10 01.
Article in English | MEDLINE | ID: mdl-35894598

ABSTRACT

OBJECTIVES: Randomized clinical trials (RCTs) conducted in adult ICU patients increasingly include patient-important outcomes other than mortality. This comes with challenges regarding outcome choices/definitions, handling of deceased patients and missing data in analyses, and choices of effect measures and statistical methods due to complex distributions. This scoping review aimed to characterize how these challenges are handled in relevant contemporary RCTs. DATA SOURCES: We systematically searched 10 selected journals for RCTs conducted primarily in adult ICU patients published between 1 January 2018 and 5 May 2022 reporting at least one patient-important outcome other than mortality, including "days alive without"…-type outcomes, functional/cognitive/neurologic outcomes, health-related quality of life (HRQoL) outcomes, and ordinal/other outcomes. STUDY SELECTION: Abstracts and full-texts were assessed independently and in duplicate by two reviewers. DATA EXTRACTION: Data were extracted independently and in duplicate by two reviewers using predefined and pilot-tested extraction forms and subsequently categorized to facilitate analysis. DATA SYNTHESIS: We included 687 outcomes from 167 RCTs, with 32% of RCTs using a patient-important outcome other than mortality as a (co-)primary outcome, most frequently "days alive without"…-type outcomes. Many different functional/cognitive/neurologic (103) and HRQoL (29) outcomes were reported. Handling of deceased patients varied, with analyses frequently restricted to survivors only for functional/cognitive/neurologic (62%) and HRQoL (89%) outcomes. Follow-up was generally longer and missing data proportions higher for functional/cognitive/neurologic and HRQoL outcomes. Most outcomes were analyzed using nonparametric tests (31%), linear regression/ t tests (27%), chi-square-like tests (12%), and proportional odds logistic regression (9%), often without presentation of actual treatment effects estimates (38%). CONCLUSIONS: In this sample of RCTs, substantial variation in practice and suboptimal methodological choices were observed. This calls for increased focus on standardizing outcome choices and definitions, adequate handling of missing data and deceased patients in analyses, and use of statistical methods quantifying effect sizes.


Subject(s)
Quality of Life , Survivors , Adult , Humans , Intensive Care Units , Patient Reported Outcome Measures
10.
N Engl J Med ; 386(26): 2459-2470, 2022 06 30.
Article in English | MEDLINE | ID: mdl-35709019

ABSTRACT

BACKGROUND: Intravenous fluids are recommended for the treatment of patients who are in septic shock, but higher fluid volumes have been associated with harm in patients who are in the intensive care unit (ICU). METHODS: In this international, randomized trial, we assigned patients with septic shock in the ICU who had received at least 1 liter of intravenous fluid to receive restricted intravenous fluid or standard intravenous fluid therapy; patients were included if the onset of shock had been within 12 hours before screening. The primary outcome was death from any cause within 90 days after randomization. RESULTS: We enrolled 1554 patients; 770 were assigned to the restrictive-fluid group and 784 to the standard-fluid group. Primary outcome data were available for 1545 patients (99.4%). In the ICU, the restrictive-fluid group received a median of 1798 ml of intravenous fluid (interquartile range, 500 to 4366); the standard-fluid group received a median of 3811 ml (interquartile range, 1861 to 6762). At 90 days, death had occurred in 323 of 764 patients (42.3%) in the restrictive-fluid group, as compared with 329 of 781 patients (42.1%) in the standard-fluid group (adjusted absolute difference, 0.1 percentage points; 95% confidence interval [CI], -4.7 to 4.9; P = 0.96). In the ICU, serious adverse events occurred at least once in 221 of 751 patients (29.4%) in the restrictive-fluid group and in 238 of 772 patients (30.8%) in the standard-fluid group (adjusted absolute difference, -1.7 percentage points; 99% CI, -7.7 to 4.3). At 90 days after randomization, the numbers of days alive without life support and days alive and out of the hospital were similar in the two groups. CONCLUSIONS: Among adult patients with septic shock in the ICU, intravenous fluid restriction did not result in fewer deaths at 90 days than standard intravenous fluid therapy. (Funded by the Novo Nordisk Foundation and others; CLASSIC ClinicalTrials.gov number, NCT03668236.).


Subject(s)
Fluid Therapy , Shock, Septic , Administration, Intravenous , Adult , Critical Care/methods , Fluid Therapy/adverse effects , Fluid Therapy/methods , Humans , Intensive Care Units , Shock, Septic/mortality , Shock, Septic/therapy
11.
Intensive Care Med ; 48(7): 801-810, 2022 07.
Article in English | MEDLINE | ID: mdl-35587274

ABSTRACT

PURPOSE: The aim of this Intensive Care Medicine Rapid Practice Guideline (ICM­RPG) was to formulate evidence­based guidance for the use of dexmedetomidine for sedation in invasively mechanically ventilated adults in the intensive care unit (ICU). METHODS: We adhered to the methodology for trustworthy clinical practice guidelines, including use of the Grading of Recommendations Assessment, Development, and Evaluation approach to assess the certainty of evidence, and the Evidence-to-Decision framework to generate recommendations. The guideline panel comprised 28 international panelists, including content experts, ICU clinicians, methodologists, and patient representatives. Through teleconferences and web­based discussions, the panel provided input on the balance and magnitude of the desirable and undesirable effects, the certainty of evidence, patients' values and preferences, costs and resources, feasibility, acceptability, and research priorities. RESULTS: The ICM­RPG panel issued one weak recommendation (suggestion) based on overall moderate certainty of evidence: "In invasively mechanically ventilated adult ICU patients, we suggest using dexmedetomidine over other sedative agents, if the desirable effects including a reduction in delirium are valued over the undesirable effects including an increase in hypotension and bradycardia". CONCLUSION: This ICM-RPG provides updated evidence-based guidance on the use of dexmedetomidine for sedation in mechanically ventilated adults, and outlines uncertainties and research priorities.


Subject(s)
Anesthesia , Dexmedetomidine , Adult , Dexmedetomidine/therapeutic use , Humans , Hypnotics and Sedatives/therapeutic use , Intensive Care Units , Respiration, Artificial/methods
12.
Acta Anaesthesiol Scand ; 66(5): 636-637, 2022 05.
Article in English | MEDLINE | ID: mdl-35170027

ABSTRACT

The Clinical Practice Committee of the Scandinavian Society of Anaesthesiology and Intensive Care Medicine endorses the Living WHO guideline on therapeutics and COVID-19. This trustworthy continuously updated guideline serves as a highly useful decision aid for Nordic anaesthesiologists caring for patients with COVID-19.


Subject(s)
Anesthesiology , COVID-19 , Critical Care , Humans , Societies, Medical , World Health Organization
15.
Br J Anaesth ; 128(1): 55-64, 2022 Jan.
Article in English | MEDLINE | ID: mdl-34674834

ABSTRACT

BACKGROUND: In the Handling Oxygenation Targets in the Intensive Care Unit (HOT-ICU) trial, a lower (8 kPa) vs a higher (12 kPa) PaO2 target did not affect mortality amongst critically ill adult patients. We used Bayesian statistics to evaluate any heterogeneity in the effect of oxygenation targets on mortality between different patient groups within the HOT-ICU trial. METHODS: We analysed 90-day all-cause mortality using adjusted Bayesian logistic regression models, and assessed heterogeneous treatment effects according to four selected baseline variables using both hierarchical models of subgroups and models with interactions on the continuous scales. Results are presented as mortality probability (%) and relative risk (RR) with 95% credibility intervals (CrI). RESULTS: All 2888 patients in the intention-to-treat cohort of the HOT-ICU trial were included. The adjusted 90-day mortality rates were 43.0% (CrI: 38.3-47.8%) and 42.3% (CrI: 37.7-47.1%) in the lower and higher oxygenation groups, respectively (RR 1.02 [CrI: 0.93-1.11]), with 36.5% probability of an RR <1.00. Analyses of heterogeneous treatment effects suggested a dose-response relationship between baseline norepinephrine dose and increased mortality with the lower oxygenation target, with 95% probability of increased mortality associated with the lower oxygenation target as norepinephrine doses increased. CONCLUSIONS: A lower oxygenation target was unlikely to affect overall mortality amongst critically ill adult patients with acute hypoxaemic respiratory failure. However, our results suggest an increasing mortality risk for patients with a lower oxygen target as the baseline norepinephrine dose increases. These findings warrant additional investigation. CLINICAL TRIAL REGISTRATION: NCT03174002.


Subject(s)
Intensive Care Units , Norepinephrine/administration & dosage , Oxygen/metabolism , Respiratory Insufficiency/therapy , Aged , Bayes Theorem , Critical Illness , Dose-Response Relationship, Drug , Female , Humans , Male , Middle Aged , Probability , Respiratory Insufficiency/mortality , Respiratory Insufficiency/physiopathology , Severity of Illness Index
16.
JAMA ; 326(18): 1807-1817, 2021 11 09.
Article in English | MEDLINE | ID: mdl-34673895

ABSTRACT

Importance: A daily dose with 6 mg of dexamethasone is recommended for up to 10 days in patients with severe and critical COVID-19, but a higher dose may benefit those with more severe disease. Objective: To assess the effects of 12 mg/d vs 6 mg/d of dexamethasone in patients with COVID-19 and severe hypoxemia. Design, Setting, and Participants: A multicenter, randomized clinical trial was conducted between August 2020 and May 2021 at 26 hospitals in Europe and India and included 1000 adults with confirmed COVID-19 requiring at least 10 L/min of oxygen or mechanical ventilation. End of 90-day follow-up was on August 19, 2021. Interventions: Patients were randomized 1:1 to 12 mg/d of intravenous dexamethasone (n = 503) or 6 mg/d of intravenous dexamethasone (n = 497) for up to 10 days. Main Outcomes and Measures: The primary outcome was the number of days alive without life support (invasive mechanical ventilation, circulatory support, or kidney replacement therapy) at 28 days and was adjusted for stratification variables. Of the 8 prespecified secondary outcomes, 5 are included in this analysis (the number of days alive without life support at 90 days, the number of days alive out of the hospital at 90 days, mortality at 28 days and at 90 days, and ≥1 serious adverse reactions at 28 days). Results: Of the 1000 randomized patients, 982 were included (median age, 65 [IQR, 55-73] years; 305 [31%] women) and primary outcome data were available for 971 (491 in the 12 mg of dexamethasone group and 480 in the 6 mg of dexamethasone group). The median number of days alive without life support was 22.0 days (IQR, 6.0-28.0 days) in the 12 mg of dexamethasone group and 20.5 days (IQR, 4.0-28.0 days) in the 6 mg of dexamethasone group (adjusted mean difference, 1.3 days [95% CI, 0-2.6 days]; P = .07). Mortality at 28 days was 27.1% in the 12 mg of dexamethasone group vs 32.3% in the 6 mg of dexamethasone group (adjusted relative risk, 0.86 [99% CI, 0.68-1.08]). Mortality at 90 days was 32.0% in the 12 mg of dexamethasone group vs 37.7% in the 6 mg of dexamethasone group (adjusted relative risk, 0.87 [99% CI, 0.70-1.07]). Serious adverse reactions, including septic shock and invasive fungal infections, occurred in 11.3% in the 12 mg of dexamethasone group vs 13.4% in the 6 mg of dexamethasone group (adjusted relative risk, 0.83 [99% CI, 0.54-1.29]). Conclusions and Relevance: Among patients with COVID-19 and severe hypoxemia, 12 mg/d of dexamethasone compared with 6 mg/d of dexamethasone did not result in statistically significantly more days alive without life support at 28 days. However, the trial may have been underpowered to identify a significant difference. Trial Registration: ClinicalTrials.gov Identifier: NCT04509973 and ctri.nic.in Identifier: CTRI/2020/10/028731.


Subject(s)
COVID-19 Drug Treatment , Dexamethasone/administration & dosage , Glucocorticoids/administration & dosage , Life Support Care , Aged , COVID-19/complications , COVID-19/mortality , Dexamethasone/adverse effects , Dose-Response Relationship, Drug , Female , Glucocorticoids/adverse effects , Humans , Hypoxia/etiology , Hypoxia/therapy , Male , Middle Aged , Mycoses/etiology , Respiration, Artificial , Shock, Septic/etiology , Single-Blind Method
17.
Acta Anaesthesiol Scand ; 65(10): 1355-1364, 2021 11.
Article in English | MEDLINE | ID: mdl-34309830

ABSTRACT

BACKGROUND: After being used for more than a decade the use of hydroxyethyl starch (HES) 130/0.38-0.45 in clinical practice was discouraged because of serious adverse events including bleeding, acute kidney injury and death. But could these adverse effects have been discovered sooner? By comparing the summary effect estimates of the adverse effects of HES 130/0.38-0.45 in different study designs we aimed to disclose any signal of this. METHODS: We systematically searched MEDLINE, EMBASE and Cochrane Library and hand-searched the reference lists of relevant studies to identify studies for inclusion. Eligible trials were randomised clinical trials (RCTs) and observational studies in patients with sepsis and randomised trials in animals with induced sepsis comparing HES 130/0.38-0.45 to any type of crystalloid. Relevant outcomes were all-cause mortality at longest follow-up, renal replacement therapy (RRT), acute kidney injury (AKI) and bleeding. We extracted data, conducted conventional meta-analyses and assessed the risk of bias and the quality of evidence. RESULTS: We included 8 RCTs including 3,273 patients, 1 observational study including 379 patients and 5 randomised animal trials including 94 test animals. There was no suggestion of interaction in subgroup analyses comparing the different study designs for any outcomes (all-cause mortality at longest follow-up p = .33; RRT p = .70; AKI p = .63; bleeding p = .20). CONCLUSIONS: We observed no interaction between the summary effect estimates of RCTs, observational studies in patients and randomised animal trials for any of the outcomes. Accordingly, we found no evidence indicating that the adverse effects of HES 130/0.38-0.45 could have been discovered sooner. SYSTEMATIC REVIEW REGISTRATION: PROSPERO ID: CRD42018103422. PROTOCOL: Johansen JR, Perner A, Brodtkorb JH, Møller MH. Use of hydroxyethyl starch in sepsis research: Protocol for a systematic review. Acta Anaesthesiol Scand. 2019;63:814-818. https://doi.org/10.1111/aas.13345.


Subject(s)
Hydroxyethyl Starch Derivatives , Sepsis , Animals , Crystalloid Solutions , Fluid Therapy , Humans , Hydroxyethyl Starch Derivatives/therapeutic use , Observational Studies as Topic , Randomized Controlled Trials as Topic , Renal Replacement Therapy , Sepsis/drug therapy
18.
Acta Anaesthesiol Scand ; 65(9): 1345-1350, 2021 Oct.
Article in English | MEDLINE | ID: mdl-34086975

ABSTRACT

BACKGROUND: Superinfection following viral infection is a known complication, which may lead to longer hospitalisation and worse outcome. Empirical antibiotic therapy may prevent bacterial superinfections, but may also lead to overuse, adverse effects and development of resistant pathogens. Knowledge about the incidence of superinfections in intensive care unit (ICU) patients with severe Coronavirus Disease 2019 (COVID-19) is limited. METHODS: We will conduct a nationwide cohort study comparing the incidence of superinfections in patients with severe COVID-19 admitted to the ICU compared with ICU patients with influenza A/B in Denmark. We will include approximately 1000 patients in each group from the time period of 1 October 2014 to 30 April 2019 and from 10 March 2020 to 1 March 2021 for patients with influenza and COVID-19, respectively. The primary outcome is any superinfection within 90 days of admission to the ICU. We will use logistic regression analysis comparing COVID-19 with influenza A/B after adjustment for relevant predefined confounders. Secondarily, we will use unadjusted and adjusted logistic regression analyses to assess six potential risk factors (sex, age, cancer [including haematological], immunosuppression and use of life support on day 1 in the ICU) for superinfections and compare outcomes in patients with COVID-19 with/without superinfections, and present descriptive data regarding the superinfections. CONCLUSION: This study will provide important knowledge about superinfections in ICU patients with severe COVID-19.


Subject(s)
COVID-19 , Influenza, Human , Superinfection , Cohort Studies , Denmark/epidemiology , Humans , Influenza, Human/complications , Influenza, Human/epidemiology , Intensive Care Units , SARS-CoV-2 , Superinfection/epidemiology
19.
Acta Anaesthesiol Scand ; 65(9): 1213-1220, 2021 Oct.
Article in English | MEDLINE | ID: mdl-33964017

ABSTRACT

BACKGROUND: Emergency abdominal surgery carries a high mortality, as patients are often frail with significant comorbidity. We aimed to evaluate the association between co-existing ischaemic vascular disease (IVD) and long-term mortality in patients undergoing emergency abdominal surgery. METHODS: We included adult emergency abdominal surgical patients operated on 13 Danish hospitals between 1 January 2009 and 31 December 2010. Appendectomies were excluded. Data were retrieved from the National Patient Registry (NPR) and the Danish Anaesthesia Database. Preoperative IVD status was retrieved from NPR. We used crude and adjusted Cox regression analysis. The primary outcome was mortality within eight years. The secondary outcome was mortality within 30 days. RESULTS: We included 4864 patients, of which 2584 (53.7%) died within 8 years. Some 20.9% (1019/4864) had preoperative IVD. The adjusted association between preoperative IVD and mortality within 8 years was hazard ratio (HR) 1.10 (95% confidence interval [CI], 1.00-1.20; P = .045). At 30 days, this association was HR 0.97 (95% CI, 0.84-1.13). CONCLUSION: In adult major emergency abdominal surgical patients, preoperative IVD was prevalent and associated with a 10% relative increase in long-term mortality, but not in short-term mortality.


Subject(s)
Abdomen , Digestive System Surgical Procedures , Vascular Diseases , Abdomen/surgery , Adult , Cohort Studies , Digestive System Surgical Procedures/mortality , Emergencies , Emergency Medical Services , Humans , Retrospective Studies , Risk Factors
20.
Acta Anaesthesiol Scand ; 65(7): 986-987, 2021 08.
Article in English | MEDLINE | ID: mdl-34048025

ABSTRACT

The Clinical Practice Committee of the Scandinavian Society of Anaesthesiology and Intensive Care Medicine endorses the clinical practice guideline New clinical guidelines on the spinal stabilisation of adult trauma patients-consensus and evidence based. The guideline can serve as a useful decision aid for clinicians caring for patients with traumatic spinal cord injury. However, it is important to acknowledge that the overall certainty of evidence supporting the guideline recommendations was low, implying that further research is likely to have an important impact on the confidence in the estimate of effect.


Subject(s)
Anesthesiology , Adult , Consensus , Critical Care , Humans , Societies, Medical
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