This phase-I pilot study aimed to assess the efficacy of KD on glucose control, ICU-LOS, and mortality in sTBI patients admitted to NSICU compared to standard carbohydrate-based tube feeds.
Adult sTBI patients admitted to the Neuroscience ICU without contraindications to KD were enrolled in prospective trial (clinicaltrials.gov ID: NCT03982602). Average daily glucose levels and insulin usage were calculated and outcomes were analyzed using the Mann-Whitney U-test, while mortality was assessed via Kaplan-Meier and Cox regression analyses. ICU-LOS comparisons were performed using T-test.
Out of 53 enrolled patients, 14 received KD and 39 received standard feeds. Most were males (89%, n=47) with a mean age of 49 (±16.9) years. No significant differences were observed in daily insulin use, cumulative insulin doses, or mean daily glucose readings over 14-day between the groups. ICU-LOS (p=0.922) and mortality (p=0.177) did not differ between groups. Mean survival was longer in the KD group (46.76 ± 6.65 days) versus the control group (28.99 ± 4.40 days), but this was not statistically significant (p=0.158).
The findings from our pilot exploratory study show that a KD can be considered for the management of sTBI patients. There is no significant difference found in mean glucose levels, ICU-LOS, or mortality. However, the observed results are limited by sample size, historical control and being an observational study prone to confounding. Nevertheless, the results provide initial data to inform the power analysis and subsequent conduct of randomized trial to generate conclusive evidence related to the efficacy of KD in sTBI patients.