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Trials Aug 2023Critically ill patients commonly receive proton pump inhibitors (PPIs) to prevent gastrointestinal (GI) bleeding from stress-induced ulceration. Despite widespread use...
Proton pump inhibitors in critically ill mechanically ventilated patients with COVID-19: protocol for a substudy of the Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial.
BACKGROUND
Critically ill patients commonly receive proton pump inhibitors (PPIs) to prevent gastrointestinal (GI) bleeding from stress-induced ulceration. Despite widespread use in the intensive care unit (ICU), observational data suggest that PPIs may be associated with adverse outcomes in patients with COVID-19 infection. This preplanned study is nested within a large randomized trial evaluating pantoprazole versus placebo in invasively ventilated patients. The 3 objectives are as follows: (1) to describe the characteristics of patients with COVID-19 in terms of demographics, biomarkers, venous thromboembolism, tracheostomy incidence and timing, and other clinical outcomes; (2) to evaluate the impact of COVID-19 infection on clinically important GI bleeding, 90-day mortality, and other outcomes compared to a propensity-matched non-infected cohort; and (3) to explore whether pantoprazole has a differential treatment effect on clinically important GI bleeding, 90-day mortality, and other outcomes in patients with and without COVID-19 infection.
METHODS
The ongoing trial Re-EValuating the Inhibition of Stress Erosions (REVISE) compares pantoprazole 40 mg IV to placebo on the primary efficacy outcome of clinically important GI bleeding and the primary safety outcome of 90-day mortality. The protocol described in this report is for a substudy focused on patients with COVID-19 infection that was not in the original pre-pandemic trial protocol. We developed a one-page case report form to characterize these patients including data related to biomarkers, venous thromboembolism, COVID-19 therapies, tracheostomy incidence and timing, duration of mechanical ventilation, and ICU and hospital stay. Our analysis will describe the trajectory of patients with COVID-19 infection, a propensity-matched analysis of infected and non-infected patients, and an extended subgroup analysis comparing the effect of PPI among patients with and without COVID-19 infection.
DISCUSSION
Prophylactic acid suppression in invasively ventilated critically ill patients with COVID-19 infection has unknown consequences. The results of these investigations will inform practice, guidelines, and future research.
TRIAL REGISTRATION
REVISE Trial [NCT03374800 December 15, 2017], COVID-19 Cohort Study [NCT05715567 February 8, 2023].
Topics: Humans; Proton Pump Inhibitors; Pantoprazole; Respiration, Artificial; Cohort Studies; Critical Illness; Venous Thromboembolism; COVID-19; Gastrointestinal Hemorrhage; Randomized Controlled Trials as Topic
PubMed: 37644556
DOI: 10.1186/s13063-023-07589-2 -
Medicina (Kaunas, Lithuania) Aug 2023: To examine the effects of the lockdown on diet adherence and stress levels in patients with laryngopharyngeal reflux (LPR). : Patients with a positive LPR diagnosis at...
: To examine the effects of the lockdown on diet adherence and stress levels in patients with laryngopharyngeal reflux (LPR). : Patients with a positive LPR diagnosis at the hypopharyngeal-esophageal impedance-pH monitoring were treated from a pre- to lockdown period with a 3-month high-protein, low-fat, alkaline, plant-based diet, with behavioral changes, and an association of pantoprazole (20 MG/d) and alginate (Gaviscon 3/d). The following patient-reported outcomes questionnaire and findings instrument were used: Reflux Symptom Score-12 (RSS-12) and Reflux Sign Assessment (RSA). At the posttreatment time, patients were invited to evaluate the impact of lockdown on diet adherence and stress management with a predefined grid of foods and beverages and the perceived stress scale (PSS), respectively. : Thirty-two patients completed the evaluations. RSS-12 and RSA significantly improved from baseline to 3-month posttreatment. Most patients experienced mild-to-severe stress levels at the end of the lockdown. The level of stress substantially increased in 11 patients (34%) due to the lockdown, while it did not change in 11 patients (44%). In 11 cases (34%), patients reported that the adherence to the anti-reflux diet was better than initially presumed thanks to the lockdown period, while 44% (N = 14) reported that the lockdown did not impact the adherence to a diet. PSS and RSS-12 were significantly correlated at the end of the pandemic (r = 0.681; < 0.001). The increase in stress level was positively associated with the lack of adherence to diet (r = 0.367; = 0.039). : During the lockdown, the diet habits of LPR patients were improved in one-third and unchanged in 44% of cases. The stress level was increased in one-third of patients, which was associated with an increase in symptom scores.
Topics: Humans; Laryngopharyngeal Reflux; Quarantine; COVID-19; Communicable Disease Control; Beverages
PubMed: 37629765
DOI: 10.3390/medicina59081475 -
Frontiers in Pharmacology 2023Metoclopramide is indicated for the management of gastroesophageal reflux, gastric stasis, nausea, and vomiting. Metoclopramide-induced acute dystonic reactions...
Metoclopramide is indicated for the management of gastroesophageal reflux, gastric stasis, nausea, and vomiting. Metoclopramide-induced acute dystonic reactions (MIADRs), along with repetitive involuntary protrusion of the tongue, are well-known phenomena in children and young adults that may appear after the first dose. The drug is primarily metabolized via oxidation by the cytochrome P450 enzyme CYP2D6 and to a lesser extent by CYP3A4 and CYP1A2. A recommendation to decrease metoclopramide dosing in patients with severely limited to no CYP2D6 activity (i.e., poor metabolizers, PMs) is included in the drug label. It is important to note, however, that a requirement or recommendation for pre-emptive testing for CYP2D6 metabolizer status is not included in the drug label. We present two cases of acute dystonia in two non-consanguineous male adolescents: one following metoclopramide and cimetidine administration in a 14-year-old to treat gastroesophageal reflux, and another following metoclopramide and pantoprazole administration in a 17-year-old with acute gastroenteritis. A retrospective pharmacogenetic analysis revealed both patients as CYP2D6 PMs.
PubMed: 37497103
DOI: 10.3389/fphar.2023.1201566 -
JGH Open : An Open Access Journal of... Jul 2023There is limited research on the use of histamine-H2 receptor antagonists and proton pump inhibitors for treating COVID-19. We compare clinical outcomes between patients...
BACKGROUND AND AIM
There is limited research on the use of histamine-H2 receptor antagonists and proton pump inhibitors for treating COVID-19. We compare clinical outcomes between patients hospitalized with COVID-19 receiving famotidine or pantoprazole.
METHODS
This retrospective study included 2184 patients (famotidine: = 638, pantoprazole: = 727, nonuse: = 819) aged 18 years or older treated for COVID-19 from March 2020 to March 2021. Patients who received both famotidine and pantoprazole treatments were excluded. Multivariate logistic regression was used for the primary outcome, namely all-cause mortality, and the secondary outcomes, namely mechanical ventilation, vasopressor use, acute kidney injury, and gastrointestinal bleeding. The main predictor variable was the use of famotidine or pantoprazole. Covariates were demographics, chronic diseases, and symptoms.
RESULTS
As compared to nonuse, famotidine (OR: 0.30, 95% CI: 0.20-0.44, < 0.001) and pantoprazole (OR: 0.47, 95% CI: 0.33-0.66, < 0.001) were significantly associated with lower odds for all-cause mortality. Comparison of famotidine and pantoprazole showed that the former had lower odds for all-cause mortality (OR: 0.65, 95% CI:0.45-0.95, < 0.05), mechanical ventilation (OR: 0.38, 95% CI: 0.25-0.58, < 0.001), vasopressor use (OR: 0.33, 95% CI: 0.22-0.48, < 0.001), acute kidney injury (OR: 0.40, 95% CI: 0.30-0.54, < 0.001), and gastrointestinal bleeding (OR: 0.15, 95% CI: 0.08, 0.29, < 0.001).
CONCLUSIONS
Famotidine is associated with lower odds for all-cause mortality, mechanical ventilation, vasopressor use, acute kidney injury, and gastrointestinal bleeding as compared to pantoprazole in patients hospitalized with COVID-19. We recommend that clinicians consider the use of famotidine over pantoprazole for hospitalized COVID-19 patients. Future research with a clinical trial would be beneficial to further support such use of famotidine.
PubMed: 37496815
DOI: 10.1002/jgh3.12905 -
European Journal of Clinical... Aug 2023In a critical care setting, we aimed to identify and solve physico-chemical drug incompatibilities in central-venous catheters considering the staffs' knowledge and...
PURPOSE
In a critical care setting, we aimed to identify and solve physico-chemical drug incompatibilities in central-venous catheters considering the staffs' knowledge and assumptions about incompatibilities.
METHODS
(i) After positive ethical vote, an algorithm to identify incompatibilities was developed and applied. The algorithm was based on KIK database and Stabilis database, the drug label, and Trissel textbook. (ii) A questionnaire was created and used that asked staff for knowledge and assumptions about incompatibilities. (iii) A 4-step avoidance recommendation was developed and applied.
RESULTS
(i) At least one incompatibility was identified in 64 (61.4%) of 104 enrolled patients. Eighty one (62.3%) of 130 incompatible combinations affected piperacillin/tazobactam and in 18 (13.8%) each furosemide and pantoprazole. (ii) 37.8% (n = 14) of the staff members participated in the questionnaire survey (median age: 31, IQR: 4.75 years). The combination of piperacillin/tazobactam and pantoprazole was incorrectly judged to be compatible by 85.7%. Only rarely felt the majority of respondents unsafe in administering drugs (median score: 1; 0, never to 5, always). (iii) In those 64 patients with at least one incompatibility, 68 avoidance recommendations were given, and all were fully accepted. In 44 (64.7%) of 68 recommendations "Step 1: Administer sequentially" was suggested as a avoidance strategy. In 9/68 (13.2%) "Step 2: Use another lumen", in 7/68 (10.3%) "Step 3: Take a break", and in 8/68 (11.8%) "Step 4: Use catheters with more lumens" were recommended.
CONCLUSIONS
Although incompatibilities were common, the staff rarely felt unsafe when administering drugs. Knowledge deficits correlated well with the incompatibilities identified. All recommendations were fully accepted.
Topics: Humans; Adult; Pantoprazole; Critical Care; Piperacillin, Tazobactam Drug Combination; Algorithms; Catheters
PubMed: 37284873
DOI: 10.1007/s00228-023-03509-0