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5 result(s) for "Pastewski, Andrew"
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Catheters and the Treatment of Acute Lung Injury
To the Editor: The National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network reports an increased incidence of arrhythmias among patients who received a pulmonary-artery catheter (PAC), as compared with a central venous catheter (CVC) (May 25 issue). 1 The authors attribute this difference to the arrhythmogenic effects of the PAC and its insertion. In Table 1 of the article, they report that vasopressor use was 36 percent in the PAC group, as compared with 30 percent in the CVC group. The difference was significant. It is well known that vasopressors can cause both atrial and . . .
Umbilical cord mesenchymal stem cells for COVID-19 ARDS: a double blind, phase 1/2a, randomized controlled trial,Umbilical cord mesenchymal stem cells for COVID-19 acute respiratory distress syndrome: A double-blind, phase 1/2a, randomized controlled trial
Acute respiratory distress syndrome (ARDS) in COVID-19 is associated with high mortality. Mesenchymal stem cells are known to exert immunomodulatory and anti-inflammatory effects and could yield beneficial effects in COVID-19 ARDS. The objective of this study was to determine safety and explore efficacy of umbilical cord mesenchymal stem cell (UC-MSC) infusions in subjects with COVID-19 ARDS. A double-blind, phase 1/2a, randomized, controlled trial was performed. Randomization and stratification by ARDS severity was used to foster balance among groups. All subjects were analyzed under intention to treat design. Twenty-four subjects were randomized 1:1 to either UC-MSC treatment (n = 12) or the control group (n = 12). Subjects in the UC-MSC treatment group received two intravenous infusions (at day 0 and 3) of 100 ± 20 × 106 UC-MSCs; controls received two infusions of vehicle solution. Both groups received best standard of care. Primary endpoint was safety (adverse events [AEs]) within 6 hours; cardiac arrest or death within 24 hours postinfusion). Secondary endpoints included patient survival at 31 days after the first infusion and time to recovery. No difference was observed between groups in infusion-associated AEs. No serious adverse events (SAEs) were observed related to UC-MSC infusions. UC-MSC infusions in COVID-19 ARDS were found to be safe. Inflammatory cytokines were significantly decreased in UC-MSC-treated subjects at day 6. Treatment was associated with significantly improved patient survival (91% vs 42%, P = .015), SAE-free survival (P = .008), and time to recovery (P = .03). UC-MSC infusions are safe and could be beneficial in treating subjects with COVID-19 ARDS.
Catheters and the Treatment of Acute Lung Injury/THE AUTHORS REPLY
The National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network reports an increased incidence of arrhythmias among patients who received a pulmonary-artery catheter (PAC), as compared with a central venous catheter (CVC) (May 25 issue).1 The authors attribute this difference to the arrhythmogenic effects of the PAC and its insertion. The National Heart, Lung, and Blood Institute ARDS Clinical Trials Network submitted two analyses related to the factorial Fluid and Catheter Treatment Trial (FACTT), one a comparison of the use of PACs and CVCs in patients with acute lung injury and the other a comparison of two fluid-management strategies in such patients (June 15 issue).1 However, the only information given regarding the interaction between the type of fluid management and the type of catheter is a P value of 0.26. Both the FACTT, comparing the use of PACs and CVCs to guide treatment of acute lung injury, and the accompanying editorial (May 25 issue)1 cite a study by Sandham and colleagues,2 which found no benefit from the use of the PAC in high-risk surgical patients.