Abstract Body: Introduction:
Dysphagia is a common complication in stroke patients, increasing the risk of malnutrition and aspiration pneumonia, which can lead to worsened clinical outcomes. Early enteral nutrition (EN) is recommended in clinical practice to mitigate these risks; however, the optimal rate of EN administration remains unclear. Additionally, EN administration can be time-consuming, adding to the treatment burden on both patients and healthcare providers. Rapid EN administration may provide a more efficient alternative if it can maintain a similar safety profile.
Hypothesis:
We hypothesized that rapid administration of EN could achieve complication rates comparable to conventional administration, while potentially reducing the time for EN delivery.
Methods:
This investigator-initiated, multicenter, prospective, randomized, open-label, blinded-endpoint trial included acute stroke patients with dysphagia. Patients were randomized to receive either rapid EN (>1200 ml/h) or conventional EN (<200 ml/h). The enteral feeding dose was 100 ml for the first three days and was determined for each patient from 4 to 7 days. The primary outcome was the incidence of any one or more complications (vomiting, diarrhea, or pneumonia) within seven days of EN initiation, with a non-inferiority margin of 1.22. Secondary outcomes included total EN time within seven days and the rate of favorable clinical outcomes defined as modified Rankin scale score of 0-2 at 90 days.
Results:
From October 2021 through March 2024, a total of 212 patients (median age 81 years, 49.1% male, NIHSS score 18 [11-24]) were randomized: 104 to the rapid EN group and 108 to the conventional EN group.
Complications within seven days from EN initiation occurred as follows: vomiting in 7 patients (3.3%), diarrhea in 45 patients (21.2%), and pneumonia in 37 patients (17.5%). The incidence of one or more complications was 27.9% in the rapid EN group and 40.7% in the conventional EN group (OR 0.46, 97.5% CI ∞ to 0.82, p=0.01), demonstrating non-inferiority. Total EN time was significantly shorter in the rapid EN group compared to the conventional EN group (2.3 hours vs. 13.5 hours, p<0.01). Favorable clinical outcomes at 90 days showed no significant differences between the groups (24 [23.1%] vs. 25 [23.2%], p=1.00).
Conclusions:
Rapid EN administration in acute stroke patients was non-inferior to conventional administration regarding complication rates and significantly reduced nutrition delivery time.