A922 Sequential measurement of 1 hour creatinine clearance (1-CRCL) in critically ill patients at risk of acute kidney injury (AKI)

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Goal directed fluid removal with furosemide versus placebo in intensive care patients with fluid overload: a trial protocol for a randomised, blinded trial (GODIF Trial)

BACKGROUNDFluid overload is a risk factor for mortality in intensive care unit (ICU) patients. Administration of loop diuretics is the predominant treatment of fluid overload, but evidence for its benefit is very uncertain when assessed in a systematic review of randomised clinical trials. The GODIF trial will assess the benefits and harms of goal directed fluid removal with furosemide versus placebo in ICU patients with fluid overload.METHODSAn investigator-initiated, international, randomised, stratified, blinded, parallel-group trial allocating 1000 adult ICU patients with fluid overload to infusion of furosemide versus placebo. The goal is to achieve a neutral fluid balance. The primary outcome is days alive and out of hospital 90 days after randomisation. Secondary outcomes are all-cause mortality at day 90 and 1-year after randomisation; days alive at day 90 without life support; number of participants with one or more serious adverse events or reactions; health-related quality of life; and cognitive function at 1-year follow-up. A sample size of 1000 participants is required to detect an improvement of 8% in days alive and out of hospital 90 days after randomisation with a power of 90% and a risk of type 1 error of 5%. The conclusion of the trial will be based on the point estimate and 95% confidence interval; dichotomisation will not be used.\ngov identifier: NCT04180397.PERSPECTIVEThe GODIF trial will provide important evidence of possible benefits and harms of fluid removal with furosemide in adult ICU patients with fluid overload. This article is protected by copyright. All rights reserved.</p

Existing Data Sources in Clinical Epidemiology: Database of Community Acquired Infections Requiring Hospital Referral in Eastern Denmark (DCAIED) 2018&ndash;2021

Jon Gitz Holler,1 Jens Ulrik Stæhr Jensen,2– 4 Frederik Neess Engsig,5 Morten H Bestle,3,6 Birgitte Lindegaard,1,3,7 Jens Henning Rasmussen,8 Henning Bundgaard,3,9 Finn Erland Nielsen,8 Kasper Karmark Iversen,3,10 Jesper Juul Larsen,11 Barbara Juliane Holzknecht,3,12 Jonas Boel,12,13 Pradeesh Sivapalan,2,3 Theis Skovsgaard Itenov3,14 1Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital - North Zealand, Hilleroed, Denmark; 2Department of Medicine, Section of Respiratory Medicine, Copenhagen University Hospital - Herlev and Gentofte Hospital, Copenhagen, Denmark; 3Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark; 4PERSIMUNE & CHIP: Department of Infectious Diseases, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark; 5Department of Emergency Medicine, Copenhagen University Hospital – Amager and Hvidovre, Copenhagen, Denmark; 6Department of Anesthesia and Intensive Care Medicine, Copenhagen University Hospital – North Zealand, Hilleroed, Denmark; 7Centre for Physical Activity, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark; 8Department of Emergency Medicine, Copenhagen University Hospital – Bispebjerg and Frederiksberg, Copenhagen, Denmark; 9Department of Cardiology, The Capital Region’s Unit of Inherited Cardiac Diseases, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark; 10Department of Emergency Medicine, Copenhagen University Hospital – Herlev and Gentofte, Copenhagen, Denmark; 11Department of Emergency Medicine, Copenhagen University Hospital - North Zealand, Hilleroed, Denmark; 12Department of Clinical Microbiology, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark; 13Copenhagen University Hospital - Capital Region Pharmacy, Copenhagen, Denmark; 14Department of Anesthesiology and Intensive Care Medicine, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, DenmarkCorrespondence: Jon Gitz Holler, Department of Pulmonary and Infectious Diseases, Copenhagen University Hospital - North Zealand, Copenhagen, Denmark, Tel +45-48292578, Fax +45-48293935, Email [email protected]: Infectious diseases are major health care challenges globally and a prevalent cause of admission to emergency departments. Epidemiologic characteristics and outcomes based on population level data are limited. The Database of Community Acquired Infections in Eastern Denmark (DCAIED) 2018– 2021 was established with the aim to explore and estimate the population characteristics, and outcomes of patients suffering from community acquired infections at the emergency departments in the Capital Region and the Zealand Region of Denmark using data from electronic medical records. Adult patients (≥ 18 years) presenting to the emergency department with suspected or confirmed infection are included in the cohort. Presence of sepsis and organ failure are assessed using modified criteria from the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). During the inclusion period from January 2018 to January 2022, 2,241,652 adult emergency department visits have been registered. Of these, 451,825 were unique encounters of which 60,316 fulfilled criteria of suspected infection and 28,472 fulfilled sepsis criteria and 8,027 were defined as septic shock. The database covers the entire Capital and Zealand Region of Denmark with an uptake area of 2.6 million inhabitants and includes demographic, laboratory and outcome indicators, with complete follow-up. The database is well-suited for epidemiological research for future national and international collaborations.Keywords: emergency department, infectious diseases, sepsis, shock, database, epidemiology, community acquire

Phase-3 trial of recombinant human alkaline phosphatase for patients with sepsis-associated acute kidney injury (REVIVAL).

PURPOSE: Ilofotase alfa is a human recombinant alkaline phosphatase with reno-protective effects that showed improved survival and reduced Major Adverse Kidney Events by 90 days (MAKE90) in sepsis-associated acute kidney injury (SA-AKI) patients. REVIVAL, was a phase-3 trial conducted to confirm its efficacy and safety. METHODS: In this international double-blinded randomized-controlled trial, SA-AKI patients were enrolled < 72 h on vasopressor and < 24 h of AKI. The primary endpoint was 28-day all-cause mortality. The main secondary endpoint was MAKE90, other secondary endpoints were (i) days alive and free of organ support through day 28, (ii) days alive and out of the intensive care unit (ICU) through day 28, and (iii) time to death through day 90. Prior to unblinding, the statistical analysis plan was amended, including an updated MAKE90 definition. RESULTS: Six hundred fifty patients were treated and analyzed for safety; and 649 for efficacy data (ilofotase alfa n = 330; placebo n = 319). The observed mortality rates in the ilofotase alfa and placebo groups were 27.9% and 27.9% at 28 days, and 33.9% and 34.8% at 90 days. The trial was stopped for futility on the primary endpoint. The observed proportion of patients with MAKE90A and MAKE90B were 56.7% and 37.4% in the ilofotase alfa group vs. 64.6% and 42.8% in the placebo group. Median [interquartile range (IQR)] days alive and free of organ support were 17 [0-24] and 14 [0-24], number of days alive and discharged from the ICU through day 28 were 15 [0-22] and 10 [0-22] in the ilofotase alfa and placebo groups, respectively. Adverse events were reported in 67.9% and 75% patients in the ilofotase and placebo group. CONCLUSION: Among critically ill patients with SA-AKI, ilofotase alfa did not improve day 28 survival. There may, however, be reduced MAKE90 events. No safety concerns were identified