Clinical Trials Logo

Clinical Trial Summary

Delirium is a common disorder in Intensive Care Unit (ICU) patients and is associated with serious short- and long-term consequences. This study focuses on a program of standardized nursing and physical therapy interventions to prevent delirium in the ICU, and determines the effect of the program on the number of delirium-coma-free days in 28 days and several secondary outcomes in a multicenter randomized controlled trial.


Clinical Trial Description

Delirium is a common disorder in Intensive Care Unit (ICU) patients and is associated with serious short- and long-term consequences, including re-intubations, ICU readmissions, prolonged ICU and hospital stay, persistent cognitive problems, and higher mortality rates. Considering the high incidence of delirium and its consequences, prevention of delirium is imperative. This study focuses on a program of standardized nursing and physical therapy interventions to prevent delirium in the ICU, called UNDERPIN-ICU (nUrsiNg DEliRium Preventive INterventions in the ICU).

Objective: To determine the effect of the UNDERPIN-ICU program on the number of delirium-coma-free days in 28 days and several secondary outcomes, such as delirium incidence, the number of days of survival in 28 and 90 days and delirium-related outcomes.

Design and Setting: A multicenter stepped wedge cluster randomized controlled trial.

Methods: Eight to ten Dutch ICUs will implement the UNDERPIN-ICU program in a randomized order. Every two months the UNDERPIN-ICU program will be implemented in an additional ICU following a two months period of staff training. UNDERPIN-ICU consists of standardized protocols focusing on several modifiable risk factors for delirium, including cognitive impairment, sleep deprivation, immobility and visual and hearing impairment.

Participants: ICU patients aged ≥ 18 years (surgical, medical, or trauma) and at high risk for delirium, E-PRE-DELIRIC ≥35%, will be included, unless delirium was detected prior ICU admission, expected length of ICU stay is less then one day or when delirium assessment is not possible. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03002701
Study type Interventional
Source Radboud University
Contact
Status Completed
Phase N/A
Start date December 31, 2016
Completion date May 31, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT04551508 - Delirium Screening 3 Methods Study
Recruiting NCT04792983 - Cognition and the Immunology of Postoperative Outcomes
Recruiting NCT03095417 - Improving the Recovery and Outcome Every Day After the ICU N/A
Recruiting NCT03337282 - Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients N/A
Not yet recruiting NCT04846023 - Pediatric Delirium Screening in the PICU Via EEG N/A
Not yet recruiting NCT04538469 - Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Not yet recruiting NCT03807388 - ReMindCare App for Patients From First Episode of Psychosis Unit. N/A
Withdrawn NCT02673450 - PER3 Clock Gene Polymorphism, Clock Gene Expression and Delirium in the Intensive Care Unit.
Recruiting NCT03256500 - Transcranial Direct Current Stimulation for the Treatment of Delirium N/A
Completed NCT02890927 - Geriatric-CO-mAnagement for Cardiology Patients in the Hospital N/A
Not yet recruiting NCT02892968 - ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients N/A
Recruiting NCT03165539 - Cerebral Oxygen Desaturation and Post-Operative Delirium in Thoracic Surgical Patients
Completed NCT02554253 - The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction N/A
Completed NCT02518646 - DElirium prediCtIon in the intenSIve Care Unit: Head to Head comparisON of Two Delirium Prediction Models N/A
Recruiting NCT02305589 - The Clinical Changes Before and After Sugammadex in the Patients Undergoing Hip Surgery on the Aspect of Delirium N/A
Completed NCT02628925 - Nu-DESC DK: The Danish Version of the Nursing Delirium Screening Scale N/A
Completed NCT02213900 - Preventing Post-Operative Delirium in Patients Undergoing a Pneumonectomy, Esophagectomy or Thoracotomy Phase 4
Completed NCT01199276 - Hip Fracture Surgery in Elderly Patients Phase 2
Completed NCT01291368 - Sedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in Intensive Care N/A
Completed NCT01356810 - Prophylactic Environmental Management of Delirium N/A