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1.
N Engl J Med ; 389(26): 2446-2456, 2023 Dec 28.
Artigo em Inglês | MEDLINE | ID: mdl-37952133

RESUMO

BACKGROUND: A strategy of administering a transfusion only when the hemoglobin level falls below 7 or 8 g per deciliter has been widely adopted. However, patients with acute myocardial infarction may benefit from a higher hemoglobin level. METHODS: In this phase 3, interventional trial, we randomly assigned patients with myocardial infarction and a hemoglobin level of less than 10 g per deciliter to a restrictive transfusion strategy (hemoglobin cutoff for transfusion, 7 or 8 g per deciliter) or a liberal transfusion strategy (hemoglobin cutoff, <10 g per deciliter). The primary outcome was a composite of myocardial infarction or death at 30 days. RESULTS: A total of 3504 patients were included in the primary analysis. The mean (±SD) number of red-cell units that were transfused was 0.7±1.6 in the restrictive-strategy group and 2.5±2.3 in the liberal-strategy group. The mean hemoglobin level was 1.3 to 1.6 g per deciliter lower in the restrictive-strategy group than in the liberal-strategy group on days 1 to 3 after randomization. A primary-outcome event occurred in 295 of 1749 patients (16.9%) in the restrictive-strategy group and in 255 of 1755 patients (14.5%) in the liberal-strategy group (risk ratio modeled with multiple imputation for incomplete follow-up, 1.15; 95% confidence interval [CI], 0.99 to 1.34; P = 0.07). Death occurred in 9.9% of the patients with the restrictive strategy and in 8.3% of the patients with the liberal strategy (risk ratio, 1.19; 95% CI, 0.96 to 1.47); myocardial infarction occurred in 8.5% and 7.2% of the patients, respectively (risk ratio, 1.19; 95% CI, 0.94 to 1.49). CONCLUSIONS: In patients with acute myocardial infarction and anemia, a liberal transfusion strategy did not significantly reduce the risk of recurrent myocardial infarction or death at 30 days. However, potential harms of a restrictive transfusion strategy cannot be excluded. (Funded by the National Heart, Lung, and Blood Institute and others; MINT ClinicalTrials.gov number, NCT02981407.).


Assuntos
Anemia , Transfusão de Sangue , Infarto do Miocárdio , Humanos , Anemia/sangue , Anemia/etiologia , Anemia/terapia , Transfusão de Sangue/métodos , Transfusão de Eritrócitos/efeitos adversos , Transfusão de Eritrócitos/métodos , Hemoglobinas/análise , Infarto do Miocárdio/sangue , Infarto do Miocárdio/complicações , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/terapia , Recidiva
3.
Am Heart J ; 259: 87-96, 2023 05.
Artigo em Inglês | MEDLINE | ID: mdl-36754105

RESUMO

BACKGROUND: Perioperative atrial fibrillation (AF) and myocardial injury after noncardiac surgery (MINS) are common complications after noncardiac surgery. Inflammation has been implicated in the pathogenesis of both disorders. The COP-AF trial tests the hypothesis that colchicine reduces the incidence of perioperative AF and MINS in patients undergoing major noncardiac thoracic surgery. METHODS AND RESULTS: The 'COlchicine for the Prevention of Perioperative Atrial Fibrillation' (COP-AF) trial is an international, blinded, randomized trial that compares colchicine to placebo in patients aged at least 55 years and undergoing major noncardiac thoracic surgery with general anesthesia. Exclusion criteria include a history of AF and a contraindication to colchicine (eg, severe renal dysfunction). Oral colchicine at a dose of 0.5 mg or matching placebo is given within 4 hours before surgery. Thereafter, patients receive colchicine 0.5 mg or placebo twice daily for a total of 10 days. The 2 independent co-primary outcomes are clinically important perioperative AF (including atrial flutter) and MINS during 14 days of follow-up. The main safety outcomes are sepsis or infection and non-infectious diarrhea. We aim to enroll 3,200 patients from approximately 40 sites across 11 countries to have at least 80% power for the independent evaluation of the 2 co-primary outcomes. The COP-AF main results are expected in 2023. CONCLUSIONS: COP-AF is a large randomized and blinded trial designed to determine whether colchicine reduces the risk of perioperative AF or MINS in patients who have major noncardiac thoracic surgery.


Assuntos
Fibrilação Atrial , Cirurgia Torácica , Humanos , Fibrilação Atrial/prevenção & controle , Fibrilação Atrial/complicações , Colchicina/uso terapêutico , Incidência , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/prevenção & controle , Complicações Pós-Operatórias/tratamento farmacológico
8.
Pilot Feasibility Stud ; 6: 104, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32699643

RESUMO

BACKGROUND: Surgical bleeding is associated with postoperative cardiovascular complications. The efficacy and safety of tranexamic acid (TXA) in noncardiac surgery are still uncertain. Statins may prevent perioperative cardiovascular complications. We conducted a pilot to assess the feasibility of a perioperative trial of TXA and rosuvastatin. METHODS: Using a factorial design, we randomized patients at cardiovascular risk undergoing noncardiac surgery to intravenous TXA (1 g at the start and end of surgery) or placebo, and oral rosuvastatin (40 mg before and 20 mg daily for 30 days after surgery) or placebo. Feasibility outcomes included recruitment rates, follow-up, and compliance to interventions. Clinical outcomes were secondarily explored. RESULTS: After 3 months, we changed the design to a partial factorial due to the difficult recruitment of statin-naive patients. Over 6 months, 100 patients were randomized in the TXA trial (49 TXA, 51 placebo), 34 in the rosuvastatin trial (18 rosuvastatin, 16 placebo). Ninety-two percent (95% CI 80-98) of TXA and 86% (95% CI 74-94) of TXA-placebo patients received the 2 study doses. Thirty-three percent (95% CI 13-59) of rosuvastatin patients and 37% (95% CI 15-65) of rosuvastatin-placebo patients discontinued the study drug. A major cardiovascular complication occurred at 30 days in 1 TXA and 6 TXA-placebo patients, and 1 rosuvastatin and no rosuvastatin-placebo patients. CONCLUSIONS: Our pilot study supports the feasibility of a perioperative TXA trial in noncardiac surgery. Feasibility of a perioperative rosuvastatin trial is uncertain because of a high prevalence of statin use in the target population and concerns about compliance. TRIAL REGISTRATION: ClinicalTrials.govNCT02546648.

9.
Can J Neurol Sci ; 47(3): 289-300, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32029015

RESUMO

Cannabidiol (CBD) has been generating increasing interest in medicine due to its therapeutic properties and an apparent lack of negative side effects. Research has suggested that high dosages of CBD can be taken acutely and chronically with little to no risk. This review focuses on the neuroprotective effects of a CBD, with an emphasis on its implications for recovering from a mild traumatic brain injury (TBI) or concussion. CBD has been shown to influence the endocannabinoid system, both by affecting cannabinoid receptors and other receptors involved in the endocannabinoid system such as vanilloid receptor 1, adenosine receptors, and 5-hydroxytryptamine via cannabinoid receptor-independent mechanisms. Concussions can result in many physiological consequences, potentially resulting in post-concussion syndrome. While impairments in cerebrovascular and cardiovascular physiology following concussion have been shown, there is unfortunately still no single treatment available to enhance recovery. CBD has been shown to influence the blood brain barrier, brain-derived neurotrophic factors, cognitive capacity, the cerebrovasculature, cardiovascular physiology, and neurogenesis, all of which have been shown to be altered by concussion. CBD can therefore potentially provide treatment to enhance neuroprotection by reducing inflammation, regulating cerebral blood flow, enhancing neurogenesis, and protecting the brain against reactive oxygen species. Double-blind randomized controlled trials are still required to validate the use of CBD as medication following mild TBIs, such as concussion.


Assuntos
Concussão Encefálica/tratamento farmacológico , Canabidiol/uso terapêutico , Fármacos Neuroprotetores/uso terapêutico , Síndrome Pós-Concussão/tratamento farmacológico , Anticonvulsivantes/uso terapêutico , Barreira Hematoencefálica/metabolismo , Concussão Encefálica/imunologia , Concussão Encefálica/metabolismo , Concussão Encefálica/fisiopatologia , Fator Neurotrófico Derivado do Encéfalo/metabolismo , Circulação Cerebrovascular , Cognição , Endocanabinoides/metabolismo , Humanos , Inflamação , Neurogênese , Neuroproteção , Estresse Oxidativo , PPAR gama/metabolismo , Síndrome Pós-Concussão/imunologia , Síndrome Pós-Concussão/metabolismo , Síndrome Pós-Concussão/fisiopatologia , Receptor CB1 de Canabinoide/metabolismo , Receptor CB2 de Canabinoide/metabolismo , Receptor 5-HT1A de Serotonina/metabolismo , Receptores Purinérgicos P1/metabolismo , Canais de Cátion TRPV/metabolismo
10.
BMJ Open ; 9(9): e033150, 2019 09 24.
Artigo em Inglês | MEDLINE | ID: mdl-31551393

RESUMO

INTRODUCTION: Inflammation, dehydration, hypotension and bleeding may all contribute to the development of acute kidney injury (AKI). Accelerated surgery after a hip fracture can decrease the exposure time to such contributors and may reduce the risk of AKI. METHODS AND ANALYSIS: Hip fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) is a multicentre, international, parallel-group randomised controlled trial (RCT). Patients who suffer a hip fracture are randomly allocated to either accelerated medical assessment and surgical repair with a goal of surgery within 6 hours of diagnosis or standard care where a repair typically occurs 24 to 48 hours after diagnosis. The primary outcome of this substudy is the development of AKI within 7 days of randomisation. We anticipate at least 1998 patients will participate in this substudy. ETHICS AND DISSEMINATION: We obtained ethics approval for additional serum creatinine recordings in consecutive patients enrolled at 70 participating centres. All patients provide consent before randomisation. We anticipate reporting substudy results by 2021. TRIAL REGISTRATION NUMBER: NCT02027896; Pre-results.


Assuntos
Injúria Renal Aguda , Fixação de Fratura , Fraturas do Quadril , Complicações Pós-Operatórias/prevenção & controle , Risco Ajustado/métodos , Tempo para o Tratamento/normas , Injúria Renal Aguda/etiologia , Injúria Renal Aguda/prevenção & controle , Adulto , Feminino , Fixação de Fratura/efeitos adversos , Fixação de Fratura/métodos , Fraturas do Quadril/diagnóstico , Fraturas do Quadril/fisiopatologia , Fraturas do Quadril/cirurgia , Humanos , Masculino , Planejamento de Assistência ao Paciente/normas , Medição de Risco/métodos , Fatores de Risco
11.
BMJ Open ; 9(4): e028537, 2019 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-31048449

RESUMO

INTRODUCTION: Annually, millions of adults suffer hip fractures. The mortality rate post a hip fracture is 7%-10% at 30 days and 10%-20% at 90 days. Observational data suggest that early surgery can improve these outcomes in hip fracture patients. We designed a clinical trial-HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) to determine the effect of accelerated surgery compared with standard care on the 90-day risk of all-cause mortality and major perioperative complications. METHODS AND ANALYSIS: HIP ATTACK is a multicentre, international, parallel group randomised controlled trial (RCT) that will include patients ≥45 years of age and diagnosed with a hip fracture from a low-energy mechanism requiring surgery. Patients are randomised to accelerated medical assessment and surgical repair (goal within 6 h) or standard care. The co-primary outcomes are (1) all-cause mortality and (2) a composite of major perioperative complications (ie, mortality and non-fatal myocardial infarction, pulmonary embolism, pneumonia, sepsis, stroke, and life-threatening and major bleeding) at 90 days after randomisation. All patients will be followed up for a period of 1 year. We will enrol 3000 patients. ETHICS AND DISSEMINATION: All centres had ethics approval before randomising patients. Written informed consent is required for all patients before randomisation. HIP ATTACK is the first large international trial designed to examine whether accelerated surgery can improve outcomes in patients with a hip fracture. The dissemination plan includes publishing the results in a policy-influencing journal, conference presentations, engagement of influential medical organisations, and providing public awareness through multimedia resources. TRIAL REGISTRATION NUMBER: NCT02027896; Pre-results.


Assuntos
Fraturas do Quadril/cirurgia , Idoso , Feminino , Fraturas do Quadril/mortalidade , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/epidemiologia , Projetos de Pesquisa , Fatores de Tempo
12.
J Oral Maxillofac Surg ; 77(5): 1073.e1-1073.e11, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30557529

RESUMO

A 61-year-old woman who lost her nose, upper lip, and most of her midface bony structures because of cancer 20 years previously underwent advanced surgical reconstruction. This patient previously underwent multiple reconstructive surgeries that failed to satisfactorily restore her nose. Therefore, a multistage reconstruction was performed to recreate a complete nose and increase her upper lip length. Because of a lack of sufficient facial bone and nasal supporting structures, the reconstruction was extremely challenging. Virtual surgical planning technology was used to create a customized titanium nasal plate. The patient's nose was successfully reconstructed using the nasal plate, costal cartilage, and a paramedian forehead flap. The patient is highly satisfied with the cosmetic and functional results and has had marked psychosocial improvement since the reconstruction.


Assuntos
Neoplasias Nasais , Procedimentos de Cirurgia Plástica , Rinoplastia , Feminino , Testa , Humanos , Pessoa de Meia-Idade , Nariz , Neoplasias Nasais/cirurgia , Retalhos Cirúrgicos
15.
Lancet ; 391(10137): 2325-2334, 2018 06 09.
Artigo em Inglês | MEDLINE | ID: mdl-29900874

RESUMO

BACKGROUND: Myocardial injury after non-cardiac surgery (MINS) increases the risk of cardiovascular events and deaths, which anticoagulation therapy could prevent. Dabigatran prevents perioperative venous thromboembolism, but whether this drug can prevent a broader range of vascular complications in patients with MINS is unknown. The MANAGE trial assessed the potential of dabigatran to prevent major vascular complications among such patients. METHODS: In this international, randomised, placebo-controlled trial, we recruited patients from 84 hospitals in 19 countries. Eligible patients were aged at least 45 years, had undergone non-cardiac surgery, and were within 35 days of MINS. Patients were randomly assigned (1:1) to receive dabigatran 110 mg orally twice daily or matched placebo for a maximum of 2 years or until termination of the trial and, using a partial 2-by-2 factorial design, patients not taking a proton-pump inhibitor were also randomly assigned (1:1) to omeprazole 20 mg once daily, for which results will be reported elsewhere, or matched placebo to measure its effect on major upper gastrointestinal complications. Research personnel randomised patients through a central 24 h computerised randomisation system using block randomisation, stratified by centre. Patients, health-care providers, data collectors, and outcome adjudicators were masked to treatment allocation. The primary efficacy outcome was the occurrence of a major vascular complication, a composite of vascular mortality and non-fatal myocardial infarction, non-haemorrhagic stroke, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism. The primary safety outcome was a composite of life-threatening, major, and critical organ bleeding. Analyses were done according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, number NCT01661101. FINDINGS: Between Jan 10, 2013, and July 17, 2017, we randomly assigned 1754 patients to receive dabigatran (n=877) or placebo (n=877); 556 patients were also randomised in the omeprazole partial factorial component. Study drug was permanently discontinued in 401 (46%) of 877 patients allocated to dabigatran and 380 (43%) of 877 patients allocated to placebo. The composite primary efficacy outcome occurred in fewer patients randomised to dabigatran than placebo (97 [11%] of 877 patients assigned to dabigatran vs 133 [15%] of 877 patients assigned to placebo; hazard ratio [HR] 0·72, 95% CI 0·55-0·93; p=0·0115). The primary safety composite outcome occurred in 29 patients (3%) randomised to dabigatran and 31 patients (4%) randomised to placebo (HR 0·92, 95% CI 0·55-1·53; p=0·76). INTERPRETATION: Among patients who had MINS, dabigatran 110 mg twice daily lowered the risk of major vascular complications, with no significant increase in major bleeding. Patients with MINS have a poor prognosis; dabigatran 110 mg twice daily has the potential to help many of the 8 million adults globally who have MINS to reduce their risk of a major vascular complication [corrected]. FUNDING: Boehringer Ingelheim and Canadian Institutes of Health Research.


Assuntos
Dabigatrana/farmacologia , Hemorragia/complicações , Infarto do Miocárdio/tratamento farmacológico , Doença Arterial Periférica/complicações , Acidente Vascular Cerebral/complicações , Tromboembolia Venosa/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Antitrombinas/farmacologia , Dabigatrana/administração & dosagem , Dabigatrana/efeitos adversos , Feminino , Hemorragia/tratamento farmacológico , Hemorragia/prevenção & controle , Humanos , Masculino , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/mortalidade , Omeprazol/administração & dosagem , Omeprazol/uso terapêutico , Período Perioperatório/mortalidade , Doença Arterial Periférica/tratamento farmacológico , Doença Arterial Periférica/prevenção & controle , Efeito Placebo , Inibidores da Bomba de Prótons/uso terapêutico , Acidente Vascular Cerebral/tratamento farmacológico , Acidente Vascular Cerebral/prevenção & controle , Trombose/patologia , Resultado do Tratamento , Troponina/efeitos dos fármacos , Troponina/metabolismo , Tromboembolia Venosa/prevenção & controle
16.
Lancet ; 391(10131): 1693-1705, 2018 04 28.
Artigo em Inglês | MEDLINE | ID: mdl-29726345

RESUMO

BACKGROUND: Supplemental oxygen is often administered liberally to acutely ill adults, but the credibility of the evidence for this practice is unclear. We systematically reviewed the efficacy and safety of liberal versus conservative oxygen therapy in acutely ill adults. METHODS: In the Improving Oxygen Therapy in Acute-illness (IOTA) systematic review and meta-analysis, we searched the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, HealthSTAR, LILACS, PapersFirst, and the WHO International Clinical Trials Registry from inception to Oct 25, 2017, for randomised controlled trials comparing liberal and conservative oxygen therapy in acutely ill adults (aged ≥18 years). Studies limited to patients with chronic respiratory diseases or psychiatric disease, patients on extracorporeal life support, or patients treated with hyperbaric oxygen therapy or elective surgery were excluded. We screened studies and extracted summary estimates independently and in duplicate. We also extracted individual patient-level data from survival curves. The main outcomes were mortality (in-hospital, at 30 days, and at longest follow-up) and morbidity (disability at longest follow-up, risk of hospital-acquired pneumonia, any hospital-acquired infection, and length of hospital stay) assessed by random-effects meta-analyses. We assessed quality of evidence using the grading of recommendations assessment, development, and evaluation approach. This study is registered with PROSPERO, number CRD42017065697. FINDINGS: 25 randomised controlled trials enrolled 16 037 patients with sepsis, critical illness, stroke, trauma, myocardial infarction, or cardiac arrest, and patients who had emergency surgery. Compared with a conservative oxygen strategy, a liberal oxygen strategy (median baseline saturation of peripheral oxygen [SpO2] across trials, 96% [range 94-99%, IQR 96-98]) increased mortality in-hospital (relative risk [RR] 1·21, 95% CI 1·03-1·43, I2=0%, high quality), at 30 days (RR 1·14, 95% CI 1·01-1·29, I2=0%, high quality), and at longest follow-up (RR 1·10, 95% CI 1·00-1·20, I2=0%, high quality). Morbidity outcomes were similar between groups. Findings were robust to trial sequential, subgroup, and sensitivity analyses. INTERPRETATION: In acutely ill adults, high-quality evidence shows that liberal oxygen therapy increases mortality without improving other patient-important outcomes. Supplemental oxygen might become unfavourable above an SpO2 range of 94-96%. These results support the conservative administration of oxygen therapy. FUNDING: None.


Assuntos
Estado Terminal/terapia , Morbidade/tendências , Oxigenoterapia/mortalidade , Oxigênio/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Tratamento Conservador/métodos , Estado Terminal/epidemiologia , Infecção Hospitalar/complicações , Infecção Hospitalar/epidemiologia , Infecção Hospitalar/mortalidade , Infecção Hospitalar/terapia , Feminino , Mortalidade Hospitalar/tendências , Humanos , Doença Iatrogênica/epidemiologia , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/complicações , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/terapia , Oxigênio/efeitos adversos , Oxigênio/provisão & distribuição , Oxigenoterapia/efeitos adversos , Oxigenoterapia/métodos , Pneumonia/complicações , Pneumonia/epidemiologia , Pneumonia/mortalidade , Pneumonia/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto , Sepse/complicações , Sepse/epidemiologia , Sepse/mortalidade , Sepse/terapia
17.
Can J Cardiol ; 34(3): 295-302, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-29398173

RESUMO

BACKGROUND: Worldwide approximately 200 million adults undergo major surgery annually, of whom 8 million are estimated to suffer a myocardial injury after noncardiac surgery (MINS). There is currently no trial data informing the management of MINS. Antithrombotic agents such as direct oral anticoagulants might prevent major vascular complications in patients with MINS. METHODS: The Management of Myocardial Injury After Noncardiac Surgery (MANAGE) trial is a large international blinded randomized controlled trial of dabigatran vs placebo in patients who suffered MINS. We used a partial factorial design to also determine the effect of omeprazole vs placebo in reducing upper gastrointestinal bleeding and complications. Both study drugs were initiated in eligible patients within 35 days of suffering MINS and continued for a maximum of 2 years. The primary outcome is a composite of major vascular complications for the dabigatran trial and a composite of upper gastrointestinal complications for the omeprazole trial. We present the rationale and design of the trial and baseline characteristics of enrolled patients. RESULTS: The trial randomized 1754 patients between January 2013 and July 2017. Patients' mean age was 69.9 years, 51.1% were male, 14.3% had a history of peripheral artery disease, 6.6% had a history of stroke or transient ischemic attack, 12.9% had a previous myocardial infarction, and 26.0% had diabetes. The diagnosis of MINS was on the basis of an isolated ischemic troponin elevation in 80.4% of participants. CONCLUSION: MANAGE is the first randomized controlled trial to evaluate a potential treatment of patients who suffered MINS.


Assuntos
Causas de Morte , Dabigatrana/uso terapêutico , Infarto do Miocárdio/tratamento farmacológico , Infarto do Miocárdio/etiologia , Omeprazol/uso terapêutico , Complicações Pós-Operatórias/epidemiologia , Procedimentos Cirúrgicos Operatórios/efeitos adversos , Idoso , Método Duplo-Cego , Feminino , Seguimentos , Humanos , Internacionalidade , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Complicações Pós-Operatórias/prevenção & controle , Modelos de Riscos Proporcionais , Medição de Risco , Procedimentos Cirúrgicos Operatórios/métodos , Análise de Sobrevida , Resultado do Tratamento
19.
Eur J Cardiothorac Surg ; 53(4): 822-827, 2018 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-29186389

RESUMO

OBJECTIVES: This substudy of the colchicine for prevention of perioperative atrial fibrillation (COP-AF) pilot trial seeks to assess the effect of colchicine administration on the volume of postoperative pleural drainage, duration of chest tube in situ and length of stay following lung resection. METHODS: Between April 2014 and April 2015, 100 patients undergoing lung resection at 2 tertiary care centres participated in a pilot blinded randomized trial comparing perioperative twice daily 0.6 mg of colchicine orally (n = 49) or placebo (n = 51) twice daily for 10 days. The primary outcome was total pleural drainage volume, which was recorded in 8-h intervals for the first 2 postoperative days per standardized protocol. RESULTS: Only 1 patient did not complete the trial. The mean volume of pleural drainage at 40-h mark postoperation was significantly less in the colchicine group (550.9 ml) compared with the placebo group (741.3 ml, P = 0.039). Compared with the placebo group, the colchicine group showed significantly less mean pleural drainage on postoperative Day 2 (583.8 vs 763.3 ml, P = 0.039) and beyond. There were no differences in mean time to chest tube removal (6.8 days for the colchicine group vs 5.9 days for the placebo group, P = 0.585) and mean hospital length of stay (7.4 vs 6.9 days, P = 0.641). CONCLUSIONS: Oral colchicine is potentially effective in diminishing the amount of pleural drainage following lung resection and can be considered in patients at high risk of large postoperative pleural effusion. A full-scale, prospective placebo-controlled randomized trial is needed to assess the clinical significance of perioperative colchicine administration following oncological lung resection.


Assuntos
Anti-Inflamatórios/uso terapêutico , Colchicina/uso terapêutico , Pulmão/cirurgia , Derrame Pleural/prevenção & controle , Fibrilação Atrial/prevenção & controle , Tubos Torácicos , Drenagem/métodos , Estudos de Viabilidade , Humanos , Tempo de Internação , Projetos Piloto
20.
Eur J Cardiothorac Surg ; 53(5): 945-951, 2018 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-29237033

RESUMO

OBJECTIVES: We carried out a pilot randomized controlled study to determine the feasibility of a large trial evaluating the impact of colchicine versus placebo on postoperative atrial fibrillation or atrial flutter (POAF) among patients undergoing lung resection surgery. METHODS: Patients ≥55 years of age undergoing lung resection surgery were randomly assigned to receive colchicine 0.6 mg or placebo starting a few hours before surgery. Postoperatively, patients received colchicine 0.6 mg or placebo twice daily for an additional 9 days. Our feasibility outcomes included the period of time required to recruit 100 patients, the completeness of follow-up and compliance with the study drug. The primary efficacy outcome was POAF within 30 days of randomization. RESULTS: One hundred patients were randomized (49 to colchicine and 51 to placebo) over a period of 12 months at 2 centres in Canada. All patients completed the 30-day follow-up. The mean staff time required to recruit and to follow-up each patient was 165 min. In all, 71% of patients completed the study drug course without interruption. Patient refusal to continuing taking the study drug was the main reason for permanent drug discontinuation. New POAF occurred in 5 (10.2%) patients in the colchicine group and 7 (13.7%) patients in the placebo group (adjusted hazard ratio 0.69, 95% confidence interval 0.20-2.34). CONCLUSIONS: These results show the feasibility of a trial evaluating Colchicine for the prevention of perioperative Atrial Fibrillation in patients undergoing lung resection surgery. This pilot study will serve as the foundation for the large multicentre COP-AF trial.


Assuntos
Fibrilação Atrial/tratamento farmacológico , Fármacos Cardiovasculares/uso terapêutico , Colchicina/uso terapêutico , Pneumonectomia/efeitos adversos , Complicações Pós-Operatórias/tratamento farmacológico , Idoso , Fibrilação Atrial/prevenção & controle , Canadá , Fármacos Cardiovasculares/efeitos adversos , Colchicina/efeitos adversos , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Pneumonectomia/métodos , Complicações Pós-Operatórias/prevenção & controle
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