What is the PANDORA Clinical Trial?
Prophylactic 6- hourly intravenous AcetaminopheN to prevent postoperative Delirium in Older caRdiac surgicAl patients (PANDORA) is a prospective, multicenter, randomized, placebo controlled, triple-blinded trial being conducted at six medical centers across the US with Beth Israel Deaconess Medical Center (BIDMC) as the coordinating center.
The National Institute of Aging of the National Institutes of Health supports this research under Award Number R01 AG 065554.
Prior studies: The idea of PANDORA came to being after our single center randomized control trial called DEXACET (Subramaniam et al. 2019) wherein 6-hourly use of acetaminophen for the first 48 hours in addition to the standard opioid medication demonstrated a significant reduction in the incidence and duration of postoperative delirium and decreased length of hospital stay. With PANDORA we hope to generalize these results to a wider patient population undergoing cardiac surgery. It is approved by the Institutional Review Board at BIDMC.
Study plan: After obtaining informed written consent the participants will be randomized into two groups to receive (i) Acetaminophen or (ii) Placebo (saline) every six hours after ICU admission for 48 hours. The patients will be followed up during their hospital stay and evaluated for postoperative delirium using a battery of cognitive assessment tools. In addition to short-term outcomes, we will evaluate the long-term outcomes post-ICU stay by following up the patients via a telephone call at 1, 6 and 12 months after discharge for delirium and functional status assessment. Blood samples will be collected pre and post-operatively and will serve as a biorepository for later analysis of biomarkers, which will help us delve deeper into understanding the pathophysiology of delirium. We hope that the results of this study will help add to current practice for better patient outcome after cardiac surgery.
This trial is registered with the National Institutes of Health under NCT04093219.
