NCT03060174 2017.
| Study name | Study of prevention of postoperative delirium to reduce Incidence of postoperative cognitive dysfunction |
| Methods | Randomised controlled trial |
| Participants | 638 patients (≥ 60 years) to undergo cardiac surgery (on‐pump/off‐pump, standard/minimal invasive) |
| Interventions | Group 1: monitoring and non‐medical prophylaxis of delirium which incorporates reorientation (watches, calendar, family photos, use of hearing aids, glasses and dentures, cognitive stimulation (newspaper, magazines, radio, television), early mobilisation, early enteral nutrition, early removal of drains or catheters, normalizing sleep‐awake‐rhythm. Group 2: standard care |
| Outcomes | Primary outcome: postoperative cognitive deficit (POCD) measured by neuropsychological test battery, analysis (change from baseline in cognitive function at day 7, 3 months and 1 year after operation) Secondary outcome: incidence and severity of postoperative delirium (from day of operation until the 7th postoperative day) measured 3 times per day via CAM‐ICU, number of patients with cardiac complications (day of operation until 7th postoperative day), length of hospital stay (from day of admission until day of discharge, up to 24 weeks), mortality (1 years), health related quality of life ( months, 1 year after operation) using short form health survey, number of patients with respiratory complications (day of operation until 7th postoperative day), number of patients with renal complications (day of operation until 7th postoperative day) daily documentation of renal complications (creatinine, haemo(dia)filtration or haemodialysis), number of patients with complications in the immuno system (day of operation until 7th postoperative day), daily documentation of parameters mirroring the immune answer (C‐reactive protein, leukocytes, procalcitonin) |
| Starting date | May 2014 |
| Contact information | Prof. Alwin E. Goetz Department of Anaesthesiology and Intensive Care Medicine, University Hospital Hamburg Eppendorf |
| Notes | ClinicalTrials.gov Identifier: NCT03060174 Status: active, not recruiting Estimated completion date: May 2019 |