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1.
Trials ; 24(1): 693, 2023 Oct 26.
Artigo em Inglês | MEDLINE | ID: mdl-37885026

RESUMO

BACKGROUND: Postoperative anaemia is common in older cardiac surgery patients and often caused by iron deficiency. Anaemia may negatively affect recovery after cardiac surgery. This study aims to determine the efficacy of treatment of postoperative iron deficiency anaemia (IDA) with intravenous iron (IVI) on disability 90 days after cardiac surgery in older patients. METHODS: This is a randomized placebo-controlled double-blind multi-centre trial. In total, 310 patients aged ≥ 70 years with moderate IDA on postoperative day 1 (haemoglobin 85-110 g/L and ferritin concentration < 100 µg/L or iron saturation < 20%) after uncomplicated elective cardiac surgery (aortic valve repair or coronary artery bypass graft surgery) will be included. Patients will be randomly allocated to receive either IVI (ferric derisomaltose) or placebo (sodium chloride 0.9%) on postoperative day 1 in a 1:1 ratio, stratified by centre and type of cardiac surgery. The primary outcome is disability measured by the 12-item World Health Organization Disability Assessment score 2.0 after 90 days. Secondary outcome measures are the number of postoperative red blood cell (RBC) transfusions, change in reticulocyte haemoglobin content (pg) from randomization to hospital discharge, Hb levels at discharge, hospital complications, dyspnoea (assessed with the Rose Dyspnoea Scale) and health-related quality of life (HRQL) (assessed with The Older Persons and Informal Caregivers-Short Form (TOPICS-SF) questionnaire) after 90 days and days alive and out of hospital after 90 days. Lastly, the functional outcomes (e.g. steep ramp or 6-min walk test) and Hb level after 90 days will be assessed as an exploratory endpoint. DISCUSSION: The results of this study will demonstrate whether early treatment of postoperative IDA with IVI improves disability at 90 days in older cardiac surgery patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT04913649. Registered on June 4, 2021.


Assuntos
Anemia Ferropriva , Anemia , Procedimentos Cirúrgicos Cardíacos , Humanos , Idoso , Idoso de 80 Anos ou mais , Ferro , Qualidade de Vida , Anemia/diagnóstico , Anemia/tratamento farmacológico , Anemia/etiologia , Anemia Ferropriva/diagnóstico , Anemia Ferropriva/tratamento farmacológico , Anemia Ferropriva/etiologia , Hemoglobinas/análise , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Dispneia , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como Assunto
2.
Ned Tijdschr Geneeskd ; 1642020 05 04.
Artigo em Holandês | MEDLINE | ID: mdl-32395969

RESUMO

Aneurysm of the abdominal aorta is common and can be treated with endovascular repair, open surgical repair or conservative treatment. Risk-stratification and treatment decision-making can be complex in frail patients and depends largely on anatomy, life-expectancy and functional capacity. Currently, risk-stratification in the Netherlands is primarily based on comorbidities and age. Insight in a patient's resilience could provide important additional information. For this reason, St. Antonius hospital has implemented an Anaesthesia Geriatric Evaluation (AGE) to screen for frailty in high risk vascular surgery patients. Results of frailty-screening are discussed in a multi-disciplinary team (MDT) to assess perioperative risk and compose a personal treatment plan. This paper presents a case-series of three patients to illustrate the additional value of MDT care and frailty-screening in a high-risk vascular surgery population.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Fragilidade/diagnóstico , Avaliação Geriátrica , Idoso , Aneurisma da Aorta Abdominal/complicações , Fragilidade/complicações , Humanos , Equipe de Assistência ao Paciente , Cuidados Pré-Operatórios , Medição de Risco , Fatores de Risco , Procedimentos Cirúrgicos Vasculares
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