دورية أكاديمية
Potassium Supplementation and Prevention of Atrial Fibrillation After Cardiac Surgery: The TIGHT K Randomized Clinical Trial.
| العنوان: | Potassium Supplementation and Prevention of Atrial Fibrillation After Cardiac Surgery: The TIGHT K Randomized Clinical Trial. |
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| المؤلفون: | O'Brien B; Deutsches Herzzentrum der Charité, Charité - Universitätsmedizin Berlin, Germany.; St Bartholomew's Hospital, Barts Health NHS Trust, London, United Kingdom.; Outcomes Research Consortium, Cleveland, Ohio., Campbell NG; University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.; Manchester University NHS Foundation Trust, Manchester, United Kingdom., Allen E; London School of Hygiene & Tropical Medicine, London, United Kingdom., Jamal Z; London School of Hygiene & Tropical Medicine, London, United Kingdom., Sturgess J; London School of Hygiene & Tropical Medicine, London, United Kingdom., Sanders J; St Bartholomew's Hospital, Barts Health NHS Trust, London, United Kingdom.; King's College London, London, United Kingdom., Opondo C; London School of Hygiene & Tropical Medicine, London, United Kingdom., Roberts N; St Bartholomew's Hospital, Barts Health NHS Trust, London, United Kingdom., Aron J; St George's University Hospital NHS Foundation Trust, London, United Kingdom., Maccaroni MR; Basildon University Hospital NHS Trust, Basildon, United Kingdom., Gould R; Leeds General Infirmary, Leeds, United Kingdom., Kirmani BH; Liverpool Heart and Chest Hospital, Liverpool, United Kingdom., Gibbison B; University of Bristol, Bristol, United Kingdom.; University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, United Kingdom., Kunst G; King's College London, London, United Kingdom.; King's College Hospital NHS Foundation Trust, London, United Kingdom., Zarbock A; University Hospital Münster, Münster, Germany., Kleine-Brüggeney M; Deutsches Herzzentrum der Charité, Charité - Universitätsmedizin Berlin, Germany., Stoppe C; Deutsches Herzzentrum der Charité, Charité - Universitätsmedizin Berlin, Germany.; University Hospital, Würzburg, Würzburg, Germany., Pearce K; Manchester University NHS Foundation Trust, Manchester, United Kingdom., Hughes M; London School of Hygiene & Tropical Medicine, London, United Kingdom.; King's College London, London, United Kingdom., Van Dyck L; London School of Hygiene & Tropical Medicine, London, United Kingdom., Evans R; London School of Hygiene & Tropical Medicine, London, United Kingdom., Montgomery HE; University College London, London, United Kingdom., Elbourne D; London School of Hygiene & Tropical Medicine, London, United Kingdom. |
| مؤلفون مشاركون: | TIGHT K investigators |
| المصدر: | JAMA [JAMA] 2024 Sep 24; Vol. 332 (12), pp. 979-988. |
| نوع المنشور: | Equivalence Trial; Journal Article; Multicenter Study |
| اللغة: | English |
| بيانات الدورية: | Publisher: American Medical Association Country of Publication: United States NLM ID: 7501160 Publication Model: Print Cited Medium: Internet ISSN: 1538-3598 (Electronic) Linking ISSN: 00987484 NLM ISO Abbreviation: JAMA Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Chicago : American Medical Association, 1960- |
| مواضيع طبية MeSH: | Atrial Fibrillation*/blood , Atrial Fibrillation*/epidemiology , Atrial Fibrillation*/etiology , Atrial Fibrillation*/prevention & control , Coronary Artery Bypass*/adverse effects , Postoperative Complications*/blood , Postoperative Complications*/epidemiology , Postoperative Complications*/etiology , Postoperative Complications*/prevention & control , Potassium*/administration & dosage , Potassium*/blood, Aged ; Female ; Humans ; Male ; Middle Aged ; Dietary Supplements ; United Kingdom/epidemiology ; Germany/epidemiology ; Prospective Studies ; Incidence ; Intention to Treat Analysis |
| مستخلص: | Importance: Supplementing potassium in an effort to maintain high-normal serum concentrations is a widespread strategy used to prevent atrial fibrillation after cardiac surgery (AFACS), but is not evidence-based, carries risks, and is costly. Objective: To determine whether a lower serum potassium concentration trigger for supplementation is noninferior to a high-normal trigger. Design, Setting, and Participants: This open-label, noninferiority, randomized clinical trial was conducted at 23 cardiac surgical centers in the United Kingdom and Germany. Between October 20, 2020, and November 16, 2023, patients with no history of atrial dysrhythmias scheduled for isolated coronary artery bypass grafting (CABG) surgery were enrolled. The last study patient was discharged from the hospital on December 11, 2023. Interventions: Patients were randomly assigned to a strategy of tight or relaxed potassium control (only supplementing if serum potassium concentration fell below 4.5 mEq/L or 3.6 mEq/L, respectively). Patients wore an ambulatory heart rhythm monitor, which was analyzed by a core laboratory masked to treatment assignment. Main Outcomes and Measures: The prespecified primary end point was clinically detected and electrocardiographically confirmed new-onset AFACS in the first 120 hours after CABG surgery or until hospital discharge, whichever occurred first. All primary outcome events were validated by an event validation committee, which was masked to treatment assignment. Noninferiority of relaxed potassium control was defined as a risk difference for new-onset AFACS with associated upper bound of a 1-sided 97.5% CI of less than 10%. Secondary outcomes included other heart rhythm-related events, clinical outcomes, and cost related to the intervention. Results: A total of 1690 patients (mean age, 65 years; 256 [15%] females) were randomized. The primary end point occurred in 26.2% of patients (n = 219) in the tight group and 27.8% of patients (n = 231) in the relaxed group, which is a risk difference of 1.7% (95% CI, -2.6% to 5.9%). There was no difference between the groups in the incidence of at least 1 AFACS episode detected by any means or by ambulatory heart rhythm monitor alone, non-AFACS dysrhythmias, in-patient mortality, or length of stay. Per-patient cost for purchasing and administering potassium was significantly lower in the relaxed group (mean difference, $111.89 [95% CI, $103.60-$120.19]; P <.001). Conclusions and Relevance: For AFACS prophylaxis, supplementation only when serum potassium concentration fell below 3.6 mEq/L was noninferior to the current widespread practice of supplementing potassium to maintain a serum potassium concentration greater than or equal to 4.5 mEq/L. The lower threshold of supplementation was not associated with any increase in dysrhythmias or adverse clinical outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT04053816. |
| فهرسة مساهمة: | Investigator: R Henderson; J Desai; D Keane; K Ruetzler; S Stevenson; R Duncker; R Magboo; NA Barrett; PM Jones; LM Yu; B Kiaii; T Lobban; J Sanders; N Roberts; S Welch; C Williams; G Hughes; V Baker; F Garcia; C Sfakianakis; M Baldey; C Chan; JC de Sousa; H Abbass; N Campbell; L Kimani; L Szentgyorgyi; L Rankin; E Athanasakis; A Muthuswamy; A Allanson; A Lewis; A Finch; F Fowe; L Paulus; BC Singh; P Mathew; RD Sunil; J Mathews; S Crasta; S Ferguson; S Allen; S Pokharel; A Nicholas; A Pailing; G Kunst; H Noble; S Saha; K O'Reilly; C Spooner; E Clarey; C Finney; A Broderick; MT Depante; D Meeks; P Pappa; LA Dymore-Brown; R Samuels; T Sandhar; F Karami; A Axalan; B Vergara; E Corcoran; M Loubani; S Ford; K Rowe; K Dobbs; J Bulemfu; P Harper; J Sanders; G Lip; BH Kirmani; M Baker; L Keogan; A Panda; A Kotalczyk; AM Fawzy; B Harikumar; C Clements; L McQuade; P Widdows; P Winstanley; S Mathew; T Collins; PP Punjabi; A Ross; D Dixit; C Lodge; E Calvelo; L Sefi; M Tuason; M Russell; M Mariveles; RT Lopez; PG Kyriazis; G Liu; J Chacko; R Gould; E Wilby; A Speight; B Ogg; S Watts; S Mathew; S Salada; S Trott; Z Friar; C Brennan; E Rawnsley; K Long; A Bose; P Martinovsky; D Sebastian; V Vasudevan; J Aron; R Handslip; S Farnell-Ward; C Aquino; M Thanasi; M Valcher; N Yun; N Al-Subaie; P Kabungo; S Dangol; V Ventura; L Whittaker; A Luna; E Fernandes; K Lloyd; MM Cordoba; R Kanu; R Juncu; S Sadeque; J Rosser; M Shoeib; A Cheng; A Ford; O Holmes; C Blackwell; M Thompson; J Waspe; J Massey; J Hyde; D Martinez; J Strikaite; L Bennett; N Skipper; S Appasamy; U Trivedi; D Balmforth; M Lewis; G Krasopoulos; L Nixon; J Sawyer; C Joines; K New; A Hartley; D Webster; A Johnson; A Kourliouros; P Sastry; N Walcot; A Proctor; V Srivastaka; C Castro; A Budden; J Park; C McMillan; G Williams; M Eladawy; R Bradbury; S Somarajan; S Jones; M Maccaroni; K Musson; J Ramirez; E Redman; F Benson; K Goodsell; M Eve; SA Matias; G Namjoshi; Y Abouelela; B Nguyen; L Madziva; O Zibdeh; A Turner; E Jones; E May; M Mills; M Mwadeyi; S Cocks; A Downing; R Mansour; H Newman; C McCormick; C England; M Kalita; F Cardinez; H El-Shafei; H Jhala; S Williams; S McDonald; V Jitendra; P Henderson; J Abernethy; M John; M Aduse-Poku; G Colville; MM Patel; M Shaw; T Ali; G Radcliffe; G Lucchese; N Nicou; E Makondo; J Quinn; JG Glizevskaja; P Anderson; L Lavorca; S Smith-Johnson; H Lushpenko-Brown; B Gibbison; E Hopkins; E Bonnick; J Irish; L Joseph; MLMR Gonzalez; P Lambert; S Rose; D Watkins; J Walach; H Vohra; P Alston; V Zamvar; A Campbell; A Geddes; G Tucker; M Callaghan; M Stagg; N Downing-James; M Glenwright; I Adamson; D Ray-Alende; M Kleine-Brueggeney; C Stoppe; D Catena; MK Matschke; N Rau; N Hellner; S Ott; V Tahirovic; A Karekla; J Knierim; A Zarbock; M Meersch-Dini; C Strauss; M Sadjadi; T von Groote; M Wessels; S Hollenborg; K Schützenmeister; G Schedding; C Wempe; N Al-Attar; C Hamilton; E Boyd; C Lythgoe; R Jones; M Parker; J Brennan; S Walsh; A Crossley; O Hamer; S MacDonald; E Butler; J Flemming; GJ Murphy; P Sommer; R Schnabel; V Lamprou; Y Zheng; R Viswesvaraiah; S Barsamyan; J Bedford; A Adlan; M Finlay; A Gibbon; K Sandhu; J Giblett; J Barnes; S Juneja; C Cox; E Akowuah; M Kwok; J Astarci; R Canter; K Potter; L Vale |
| سلسلة جزيئية: | ClinicalTrials.gov NCT04053816 |
| المشرفين على المادة: | RWP5GA015D (Potassium) |
| تواريخ الأحداث: | Date Created: 20240831 Date Completed: 20240924 Latest Revision: 20240925 |
| رمز التحديث: | 20240926 |
| مُعرف محوري في PubMed: | PMC11366075 |
| DOI: | 10.1001/jama.2024.17888 |
| PMID: | 39215972 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1538-3598 |
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| DOI: | 10.1001/jama.2024.17888 |