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BackgroundIn this phase 2 randomised placebo-controlled clinical trial, we hypothesised that blocking mineralocorticoid receptors with spironolactone in patients with COVID-19 is safe and may reduce illness severity. MethodsHospitalised patients with confirmed COVID-19 were randomly allocated to low dose oral spironolactone (50mg day 1, then 25mg once daily for 21 days) or standard care in a 2:1 ratio. Both groups received dexamethasone 6mg for 10 days. Group allocation was blinded to the patient and research team. Primary outcomes were time to recovery, defined as the number of days until patients achieved WHO Ordinal Scale (OS) category [≤] 3, and the effect of spironolactone on aldosterone, D-dimer, angiotensin II and Von Willebrand Factor (VWF). Results120 patients were recruited in Delhi from 01 February to 30 April 2021. 74 were randomly assigned to spironolactone and dexamethasone (SpiroDex), and 46 to dexamethasone alone (Dex). There was no significant difference in the time to recovery between SpiroDex and Dex groups (SpiroDex median 4.5 days, Dex median 5.5 days, p = 0.055). SpiroDex patients had lower aldosterone levels on day 7 and lower D-dimer levels on days 4 and 7 (day 7 D-dimer mean SpiroDex 1.15{micro}g/mL, Dex 3.15 {micro}g/mL, p = 0.0004). There was no increase in adverse events in patients receiving SpiroDex. Post hoc analysis demonstrated reduced clinical deterioration (pre specified as escalating to WHO OS category >4) in the SpiroDex group vs Dex group (5.4% vs 19.6%). ConclusionLow dose oral spironolactone in addition to dexamethasone was safe and reduced D-Dimer and aldosterone. Although time to recovery was not significantly reduced, fewer patients progressed to severe disease. Phase 3 randomised controlled trials with spironolactone should be considered.
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PURPOSE: Vertical sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) are currently the most common bariatric procedures. Although the safety of these operations has markedly improved, there continues to be a certain rate of complications. Such adverse events can have a significant deleterious effect on the outcome of these procedures and represent a costly burden on patients and society at large. A better understanding of these complications and their predictive factors may help ameliorate and optimize outcomes. METHODS: Seven hundred seventy-two consecutive patients who underwent SG or RYGB for morbid obesity between January 2011 and October 2015, in the Division of Bariatric Surgery at a tertiary institution, were included through retrospective review of the medical database. The complications were categorized and evaluated according to severity using the Clavien-Dindo classification system. Significant risk factors were evaluated by binary logistic regression to identify independent predictors and analyzed to identify their relationship with the type of complication. RESULTS: Independent predictors of severe complication after these procedures included male gender, open and revisional surgery, hypertension, and hypoalbuminemia. Hypoalbuminemia had significant associations with occurrence of deep surgical site infection and leak. Open surgery had significant associations with occurrence of superficial and deep surgical site infection and respiratory complications. Independent predictors of severe complication after laparoscopic primary RYGB included previous abdominal surgery. Previous abdominal surgery had significant associations with deep surgical site infection and leak. CONCLUSION: Recognition and optimization of these risk factors would be valuable in operative risk prediction before bariatric surgery.
