المؤلفون: Vine, Jacob, Mehta, Shivani, Balaji, Lakshman, Berg, Katherine M, Berlin, Noa, Liu, Xiaowen, Ngo, Long, Shea, Meredith, Moskowitz, Ari, Donnino, Michael W, Grossestreuer, Anne V

مصطلحات موضوعية: Intensive care

الوصف: Introduction Diabetic ketoacidosis (DKA) is a potentially life-threatening diabetic complication. Despite the high prevalence of DKA and the substantial associated healthcare burden, limited research on strategies to improve outcomes currently exists. Thiamine (vitamin B1) is a cofactor of pyruvate dehydrogenase, which plays a key role in aerobic glucose metabolism. Thiamine deficiency is common in patients with DKA, resulting in a shift to anaerobic metabolism and hyperlactatemia, which can prolong and complicate recovery. Therefore, we hypothesise that thiamine administration will improve aerobic metabolism and lead to faster resolution of acidemia in patients with DKA. Methods and analysis In this single centre, double-blind, randomised, placebo-controlled, parallel group interventional trial, 100 patients admitted to the hospital with DKA will be randomised to receive either intravenous thiamine (200 mg in 50 mL 0.9% saline) or placebo (0.9% saline identical in appearance and volume) two times per day for 2 days. The primary outcome will be the change in bicarbonate level over 24 hours as compared between the two treatment groups. Additional secondary outcomes include the change over time in anion gap, lactate levels, oxygen consumption by circulating mononuclear cells, intensive care unit and hospital length-of-stay and hospital resource usage when comparing the two study arms. Ethics and dissemination This trial was approved by the Committee on Clinical Investigations, the institutional review board of Beth Israel Deaconess Medical Center (protocol number 2018P000475). Findings will be disseminated through peer-reviewed publications and professional conference presentations. Trial registration number NCT03717896 ; clinicaltrials.gov.

وصف الملف: text/html

العلاقة: http://bmjopen.bmj.com/cgi/content/short/14/2/e077586Test; http://dx.doi.org/10.1136/bmjopen-2023-077586Test

الإتاحة: https://doi.org/10.1136/bmjopen-2023-077586Test
http://bmjopen.bmj.com/cgi/content/short/14/2/e077586Test

المؤلفون: Vine, Jacob, Lee, John H., Kravitz, Max S., Grossestreuer, Anne V., Balaji, Lakshman, Leland, Shannon B., Berlin, Noa, Moskowitz, Ari, Donnino, Michael W.

المساهمون: National Heart, Lung, and Blood Institute, National Institute of General Medical Sciences, National Center for Complementary and Integrative Health

المصدر: Critical Care ; volume 28, issue 1 ; ISSN 1364-8535

مصطلحات موضوعية: Critical Care and Intensive Care Medicine

الوصف: Background This is a post hoc analysis of combined cohorts from two previous Phase II clinical trials to assess the effect of thiamine administration on kidney protection and mortality in patients with septic shock. Methods Patient-level data from the Thiamine in Septic Shock Trial (NCT01070810) and the Thiamine for Renal Protection in Septic Shock Trial (NCT03550794) were combined in this analysis. The primary outcome for the current study was survival without the receipt of renal replacement therapy (RRT). Analyses were performed on the overall cohort and the thiamine-deficient cohort (thiamine < 8 nmol/L). Results Totally, 158 patients were included. Overall, thiamine administration was associated with higher odds of being alive and RRT-free (adjusted odds ratio [aOR]: 2.05 [95% confidence interval (CI) 1.08–3.90]) and not needing RRT (aOR: 2.59 [95% CI 1.01–6.62]). In the thiamine-deficient group, thiamine administration was associated with higher odds of being alive and RRT-free (aOR: 8.17 [95% CI 1.79–37.22]) and surviving to hospital discharge (aOR: 6.84 [95% CI 1.54–30.36]). There was a significant effect modification by baseline thiamine deficiency for alive and RRT-free (interaction, p = 0.016) and surviving to hospital discharge ( p = 0.019). Conclusion In the combined analysis of two previous randomized trials, thiamine administration was associated with higher odds of being alive and RRT-free at hospital discharge in patients with septic shock. This signal was stronger in patients with thiamine deficiency.

الإتاحة: https://doi.org/10.1186/s13054-024-04818-1Test

المؤلفون: Vine, Jacob, Berlin, Noa, Moskowitz, Ari, Berg, Katherine M., Liu, Xiaowen, Balaji, Lakshman, Donnino, Michael W., Grossestreuer, Anne V.

المساهمون: National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, National Heart, Lung, and Blood Institute

المصدر: Contemporary Clinical Trials ; volume 139, page 107486 ; ISSN 1551-7144

مصطلحات موضوعية: Pharmacology (medical), General Medicine

الإتاحة: https://doi.org/10.1016/j.cct.2024.107486Test
https://api.elsevier.com/content/article/PII:S1551714424000600?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S1551714424000600?httpAccept=text/plainTest

المؤلفون: Moskowitz, Ari, Andrea, Luke, Shiloh, Ariel L., Cardasis, John, Carty, Colleen, Kim, Mimi, Xie, Xianhong, McAllen, Susan, Esses, David, Lutz, Carlo, Takematsu, Mai, Romero, Jose, Schimmrich, Kristen, Fein, Daniel G., Dodi, Amos E., Rednor, Samuel, Bangar, Maneesha, Mohamed, Amira, Eisen, Lewis A., Wang, Henry E., Donnino, Michael W., Gong, Michelle Ng

المساهمون: National Heart, Lung, and Blood Institute

المصدر: Resuscitation Plus ; volume 17, page 100512 ; ISSN 2666-5204

مصطلحات موضوعية: Cardiology and Cardiovascular Medicine, Emergency Nursing, Emergency Medicine

الإتاحة: https://doi.org/10.1016/j.resplu.2023.100512Test
https://api.elsevier.com/content/article/PII:S2666520423001558?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S2666520423001558?httpAccept=text/plainTest

المؤلفون: Hotchkiss, Richard S, Colston, Elizabeth, Yende, Sachin, Crouser, Elliott D, Martin, Greg S, Albertson, Timothy, Bartz, Raquel R, Brakenridge, Scott C, Delano, Matthew J, Park, Pauline K, Donnino, Michael W, Tidswell, Mark, Mayr, Florian B, Angus, Derek C, Coopersmith, Craig M, Moldawer, Lyle L, Catlett, Ian M, Girgis, Ihab G, Ye, June, Grasela, Dennis M

المصدر: Intensive Care Medicine. 45(10)

مصطلحات موضوعية: Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Immunology, Sepsis, Clinical Research, Hematology, Clinical Trials and Supportive Activities, Prevention, Infectious Diseases, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Infection, Inflammatory and immune system, Adult, Aged, Biomarkers, Double-Blind Method, Female, HLA-DR Antigens, Humans, Immunologic Factors, Male, Middle Aged, Nivolumab, Programmed Cell Death 1 Receptor, Anti-PD-1, Immunosuppression, Phase 1, Immune checkpoint inhibition, Public Health and Health Services, Emergency & Critical Care Medicine, Clinical sciences

الوصف: PurposeSepsis-associated immunosuppression increases hospital-acquired infection and viral reactivation risk. A key underlying mechanism is programmed cell death protein-1 (PD-1)-mediated T-cell function impairment. This is one of the first clinical safety and pharmacokinetics (PK) assessments of the anti-PD-1 antibody nivolumab and its effect on immune biomarkers in sepsis.MethodsRandomized, double-blind, parallel-group, Phase 1b study in 31 adults at 10 US hospital ICUs with sepsis diagnosed ≥ 24 h before study treatment, ≥ 1 organ dysfunction, and absolute lymphocyte count ≤ 1.1 × 103 cells/μL. Participants received one nivolumab dose [480 mg (n = 15) or 960 mg (n = 16)]; follow-up was 90 days. Primary endpoints were safety and PK parameters.ResultsTwelve deaths occurred [n = 6 per study arm; 40% (480 mg) and 37.5% (960 mg)]. Serious AEs occurred in eight participants [n = 1, 6.7% (480 mg); n = 7, 43.8% (960 mg)]. AEs considered by the investigator to be possibly drug-related and immune-mediated occurred in five participants [n = 2, 13.3% (480 mg); n = 3, 18.8% (960 mg)]. Mean ± SD terminal half-life was 14.7 ± 5.3 (480 mg) and 15.8 ± 7.9 (960 mg) days. All participants maintained > 90% receptor occupancy (RO) 28 days post-infusion. Median (Q1, Q3) mHLA-DR levels increased to 11,531 (6528, 19,495) and 11,449 (6225, 16,698) mAbs/cell in the 480- and 960-mg arms by day 14, respectively. Pro-inflammatory cytokine levels did not increase.ConclusionsIn this sepsis population, nivolumab administration did not result in unexpected safety findings or indicate any 'cytokine storm'. The PK profile maintained RO > 90% for ≥ 28 days. Further efficacy and safety studies are warranted. TRIAL REGISTRATION NUMBER (CLINICALTRIALS.GOV): NCT02960854.

وصف الملف: application/pdf

الوصول الحر: https://escholarship.org/uc/item/5mr522btTest

المؤلفون: Wyckoff, Myra H., Greif, Robert, Morley, Peter T., Ng, Kee-Chong, Olasveengen, Theresa M., Singletary, Eunice M., Soar, Jasmeet, Cheng, Adam, Drennan, Ian R., Liley, Helen G., Scholefield, Barnaby R., Smyth, Michael A., Welsford, Michelle, Zideman, David A., Acworth, Jason, Aickin, Richard, Andersen, Lars W., Atkins, Diane, Berry, David C., Bhanji, Farhan, Bierens, Joost, Borra, Vere, Boettiger, Bernd W., Bradley, Richard N., Bray, Janet E., Breckwoldt, Jan, Callaway, Clifton W., Carlson, Jestin N., Cassan, Pascal, Castren, Maaret, Chang, Wei-Tien, Charlton, Nathan P., Chung, Sung Phil, Considine, Julie, Costa-Nobre, Daniela T., Couper, Keith, Couto, Thomaz Bittencourt, Dainty, Katie N., Davis, Peter G., de Almeida, Maria Fernanda, de Caen, Allan R., Deakin, Charles D., Djarv, Therese, Donnino, Michael W., Douma, Matthew J., Duff, Jonathan P., Dunne, Cody L., Eastwood, Kathryn, El-Naggar, Walid, Fabres, Jorge G., Fawke, Joe, Finn, Judith, Foglia, Elizabeth E., Folke, Fredrik, Gilfoyle, Elaine, Goolsby, Craig A., Granfeldt, Asger, Guerguerian, Anne-Marie, Guinsburg, Ruth, Hirsch, Karen G., Holmberg, Mathias J., Hosono, Shigeharu, Hsieh, Ming-Ju, Hsu, Cindy H., Ikeyama, Takanari, Isayama, Tetsuya, Johnson, Nicholas J., Kapadia, Vishal S., Kawakami, Mandira Daripa, Kim, Han-Suk, Kleinman, Monica, Kloeck, David A., Kudenchuk, Peter J., Lagina, Anthony T., Lauridsen, Kasper G., Lavonas, Eric J., Lee, Henry C., Lin, Yiqun (Jeffrey), Lockey, Andrew S., Maconochie, Ian K., Madar, R. John, Hansen, Carolina Malta, Masterson, Siobhan, Matsuyama, Tasuku, McKinlay, Christopher J. D., Meyran, Daniel, Morgan, Patrick, Morrison, Laurie J., Nadkarni, Vinay, Nakwa, Firdose L., Nation, Kevin J., Nehme, Ziad, Nemeth, Michael, Neumar, Robert W., Nicholson, Tonia, Nikolaou, Nikolaos, Nishiyama, Chika, Norii, Tatsuya, Nuthall, Gabrielle A., O'Neill, Brian J., Ong, Yong-Kwang Gene, Orkin, Aaron M., Paiva, Edison F., Parr, Michael J., Patocka, Catherine, Pellegrino, Jeffrey L., Perkins, Gavin D., Perlman, Jeffrey M., Rabi, Yacov, Reis, Amelia G., Reynolds, Joshua C., Ristagno, Giuseppe, Rodriguez-Nunez, Antonio, Roehr, Charles C., Ruediger, Mario, Sakamoto, Tetsuya, Sandroni, Claudio, Sawyer, Taylor L., Schexnayder, Steve M., Schmolzer, Georg M., Schnaubelt, Sebastian, Semeraro, Federico, Skrifvars, Markus B., Smith, Christopher M., Sugiura, Takahiro, Tijssen, Janice A., Trevisanuto, Daniele, Van de Voorde, Patrick, Wang, Tzong-Luen, Weiner, Gary M., Wyllie, Jonathan P., Yang, Chih-Wei, Yeung, Joyce, Nolan, Jerry P., Berg, Katherine M.

المساهمون: HUS Emergency Medicine and Services, Department of Diagnostics and Therapeutics, Clinicum

مصطلحات موضوعية: AHA Scientific Statements, Advanced life support, Basic life support, Cardiac arrest, First aid, Infant, Newborn, Pediatrics, Resuscitation, 3126 Surgery, anesthesiology, intensive care, radiology

الوصف: This is the sixth annual summary of the International Liaison Committee on Resuscitation International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. This summary addresses the most recently published resuscitation evidence reviewed by International Liaison Committee on Resuscitation Task Force science experts. Topics covered by systematic reviews include cardiopulmonary resuscitation during transport; approach to resuscitation after drowning; passive ventilation; minimising pauses during cardiopulmonary resuscitation; temperature management after cardiac arrest; use of diagnostic point-of-care ultrasound during cardiac arrest; use of vasopressin and corticosteroids during cardiac arrest; coronary angiography after cardiac arrest; public-access defibrillation devices for children; pediatric early warning systems; maintaining normal temperature immediately after birth; suctioning of amniotic fluid at birth; tactile stimulation for resuscitation immediately after birth; use of continuous positive airway pressure for respiratory distress at term birth; respiratory and heart rate monitoring in the delivery room; supraglottic airway use in neonates; prearrest prediction of in-hospital cardiac arrest mortality; basic life support training for likely rescuers of high-risk populations; effect of resuscitation team training; blended learning for life support training; training and recertification for resuscitation instructors; and recovery position for maintenance of breathing and prevention of cardiac arrest. Members from 6 task forces have assessed, discussed, and debated the quality of the evidence using Grading of Recommendations Assessment, Development, and Evaluation criteria and generated consensus treatment recommendations. Insights into the deliberations of the task forces are provided in the Justification and Evidence-to-Decision Framework Highlights sections, and priority knowledge gaps for future research are listed. ; Peer reviewed

وصف الملف: application/pdf

العلاقة: Wyckoff , M H , Greif , R , Morley , P T , Ng , K-C , Olasveengen , T M , Singletary , E M , Soar , J , Cheng , A , Drennan , I R , Liley , H G , Scholefield , B R , Smyth , M A , Welsford , M , Zideman , D A , Acworth , J , Aickin , R , Andersen , L W , Atkins , D , Berry , D C , Bhanji , F , Bierens , J , Borra , V , Boettiger , B W , Bradley , R N , Bray , J E , Breckwoldt , J , Callaway , C W , Carlson , J N , Cassan , P , Castren , M , Chang , W-T , Charlton , N P , Chung , S P , Considine , J , Costa-Nobre , D T , Couper , K , Couto , T B , Dainty , K N , Davis , P G , de Almeida , M F , de Caen , A R , Deakin , C D , Djarv , T , Donnino , M W , Douma , M J , Duff , J P , Dunne , C L , Eastwood , K , El-Naggar , W , Fabres , J G , Fawke , J , Finn , J , Foglia , E E , Folke , F , Gilfoyle , E , Goolsby , C A , Granfeldt , A , Guerguerian , A-M , Guinsburg , R , Hirsch , K G , Holmberg , M J , Hosono , S , Hsieh , M-J , Hsu , C H , Ikeyama , T , Isayama , T , Johnson , N J , Kapadia , V S , Kawakami , M D , Kim , H-S , Kleinman , M , Kloeck , D A , Kudenchuk , P J , Lagina , A T , Lauridsen , K G , Lavonas , E J , Lee , H C , Lin , Y , Lockey , A S , Maconochie , I K , Madar , R J , Hansen , C M , Masterson , S , Matsuyama , T , McKinlay , C J D , Meyran , D , Morgan , P , Morrison , L J , Nadkarni , V , Nakwa , F L , Nation , K J , Nehme , Z , Nemeth , M , Neumar , R W , Nicholson , T , Nikolaou , N , Nishiyama , C , Norii , T , Nuthall , G A , O'Neill , B J , Ong , Y-K G , Orkin , A M , Paiva , E F , Parr , M J , Patocka , C , Pellegrino , J L , Perkins , G D , Perlman , J M , Rabi , Y , Reis , A G , Reynolds , J C , Ristagno , G , Rodriguez-Nunez , A , Roehr , C C , Ruediger , M , Sakamoto , T , Sandroni , C , Sawyer , T L , Schexnayder , S M , Schmolzer , G M , Schnaubelt , S , Semeraro , F , Skrifvars , M B , Smith , C M , Sugiura , T , Tijssen , J A , Trevisanuto , D , Van de Voorde , P , Wang , T-L , Weiner , G M , Wyllie , J P , Yang , C-W , Yeung , J , Nolan , J P & Berg , K M 2022 , ' 2022 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations : Summary From the Basic Life Support; Advanced Life Support; Pediatric Life Support; Neonatal Life Support; Education, Implementation, and Teams; and First Aid Task Forces ' , Resuscitation , vol. 181 , pp. 208-288 . https://doi.org/10.1016/j.resuscitation.2022.10.005Test; 1079f422-51b2-48fe-b660-43e11f5bc2f8; http://hdl.handle.net/10138/568259Test; 001072601200001

الإتاحة: http://hdl.handle.net/10138/568259Test

المؤلفون: Malley, Brian E., Yabes, Jonathan G., Gimbel, Elizabeth, Chang, Chung-Chou H., Yealy, Donald M., Fine, Michael J., Angus, Derek C., Huang, David T., Doi, Yohei, Eaton, Tammy L., Gimbel, Elizabeth A., Peck Palmer, Octavia M., Pike, Francis, Ryman, Ashley M., Weissfeld, Lisa A., Wofford, Kourtney A., Xu, Tianyuan, Donnino, Michael W., Aisiku, Imoigele P., Hou, Peter C., Seethala, Raghu R., Sherwin, Robert L., Holst, John M., Fischer, Michelle A., Rafferty, Colleen M., Dachman, William D., LoVecchio, Frank, Filbin, Michael R., Mansour, Michael K., Fine, Jonathan M., Hammel, Jean M., Exline, Matthew J., Southerland, Lauren T., Terndrup, Thomas E., Kurz, Michael C., McCullum, David L., Wang, Henry E., Amin, Alpesh N., Lotfipour, Shahram, Khan, Feras H., Gentry Wilkerson, R., Prunty, Heather A., Suffoletto, Brian, Brown, Aaron M., Jovin, Franziska F.

المساهمون: National Institute of General Medical Sciences

المصدر: BMC Infectious Diseases ; volume 23, issue 1 ; ISSN 1471-2334

مصطلحات موضوعية: Infectious Diseases

الوصف: Background The Procalcitonin Antibiotic Consensus Trial (ProACT) found provision of a procalcitonin antibiotic prescribing guideline to hospital-based clinicians did not reduce antibiotic use. Possible reasons include clinician reluctance to follow the guideline, with an observed 64.8% adherence rate. In this study we sought to determine the threshold adherence rate for reduction in antibiotic use, and to explore opportunities to increase adherence. Methods This study is a retrospective analysis of ProACT data. ProACT randomized 1656 patients presenting to 14 U.S. hospitals with suspected lower respiratory tract infection to usual care or provision of procalcitonin assay results and an antibiotic prescribing guideline to the treating clinicians. We simulated varying adherence to guideline recommendations for low procalcitonin levels and determined which threshold adherence rate could have resulted in rejection of the null hypothesis of no difference between groups at alpha = 0.05. We also performed sensitivity analyses within specific clinical settings and grouped patients initially prescribed antibiotics despite low procalcitonin into low, medium, and high risk of illness severity or bacterial infection. Results Our primary outcome was number of antibiotic-days by day 30 using an intention-to-treat approach and a null hypothesis of no difference in antibiotic use. We determined that an 84% adherence rate in the hospital setting (emergency department and inpatient) for low procalcitonin could have allowed rejection of the null hypothesis (3.7 vs 4.3 antibiotic-days, p = 0.048). The threshold adherence rate was 76% for continued guideline adherence after discharge. Even 100% adherence in the emergency department alone failed to reduce antibiotic-days. Of the 218 patients prescribed antibiotics in the emergency department despite low procalcitonin, 153 (70.2%) were categorized as low or medium risk. Conclusions High adherence in the hospital setting to a procalcitonin antibiotic prescribing guideline is ...

الإتاحة: https://doi.org/10.1186/s12879-022-07923-0Test

المؤلفون: Berlin, Noa, Pawar, Rahul D, Liu, Xiaowen, Balaji, Lakshman, Morton, Andrea C, Silverman, Jeremy, Li, Franklin, Issa, Mahmoud S, Roessler, Lara L, Holmberg, Mathias J, Shekhar, Aditya C, Donnino, Michael W, Moskowitz, Ari, Grossestreuer, Anne V

المصدر: Resuscitation ; volume 190, page 109911 ; ISSN 0300-9572

مصطلحات موضوعية: Cardiology and Cardiovascular Medicine, Emergency Nursing, Emergency Medicine

الإتاحة: https://doi.org/10.1016/j.resuscitation.2023.109911Test
https://api.elsevier.com/content/article/PII:S0300957223002241?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S0300957223002241?httpAccept=text/plainTest

المؤلفون: Pester, Bethany, Yamin, Jolin B., Cabrera, Maria J., Mehta, Shivani, Silverman, Jeremy, Grossestreuer, Anne V., Howard, Patricia, Edwards, Robert R., Donnino, Michael W.

المصدر: The Journal of Pain ; volume 24, issue 4, page 91 ; ISSN 1526-5900

مصطلحات موضوعية: Anesthesiology and Pain Medicine, Neurology (clinical), Neurology

الإتاحة: https://doi.org/10.1016/j.jpain.2023.02.261Test
https://api.elsevier.com/content/article/PII:S1526590023003000?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S1526590023003000?httpAccept=text/plainTest

المؤلفون: Ross, Catherine E., Lehmann, Sonja, Hayes, Margaret M., Yamin, Jolin B., Berg, Robert A., Kleinman, Monica E., Donnino, Michael W., Sullivan, Amy M.

المساهمون: National Institutes of Health, National Heart, Lung, and Blood Institute

المصدر: Resuscitation Plus ; volume 13, page 100355 ; ISSN 2666-5204

مصطلحات موضوعية: Cardiology and Cardiovascular Medicine, Emergency Nursing, Emergency Medicine

الإتاحة: https://doi.org/10.1016/j.resplu.2022.100355Test
https://api.elsevier.com/content/article/PII:S2666520422001552?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S2666520422001552?httpAccept=text/plainTest