Delirium Clinical Trial
— ADOMOfficial title:
Can Perioperative Goal Directed Hemodynamic Management Reduce the Incidence of Delirium in Older Patients After Major Non-cardiac Surgery?
NCT number | NCT01827501 |
Other study ID # | ADOM |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2013 |
Est. completion date | February 2021 |
Verified date | March 2021 |
Source | Technische Universität München |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is designed to compare the incidence of postoperative delirium in older patients after major non-cardiac surgery with different perioperative hemodynamic managements: a goal directed hemodynamic management group and a control group
Status | Completed |
Enrollment | 172 |
Est. completion date | February 2021 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 70 Years and older |
Eligibility | Inclusion Criteria: - Age = 70 years - Risk of perioperative delirium (Marcantonio) =6 Exclusion Criteria: - Emergency surgery - Valvular disorders grad II or higher - History of major aortic surgery - Major aortic surgery - Repeated surgery (within 30 days before) - Neurosurgery |
Country | Name | City | State |
---|---|---|---|
Germany | Klinik für Anästhesiologie Klinikum Rechts der Isar | Munich |
Lead Sponsor | Collaborator |
---|---|
Technische Universität München |
Germany,
Marcantonio ER. Postoperative delirium: a 76-year-old woman with delirium following surgery. JAMA. 2012 Jul 4;308(1):73-81. doi: 10.1001/jama.2012.6857. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of delirium until day 7 (CAM-Score and clinical diagnosis) | Delirium according to CAM-Score and clinical diagnosis | Before induction of anesthesia until 7 days after surgery | |
Secondary | Factors defining delirium | Duration of delirium, total amount of haloperidol administered | 7 days | |
Secondary | Short-term cognitive impairment | Mini Mental State on day 7 | 7 days | |
Secondary | Mortality | in-hospital mortality, mortality after one year | 1 year | |
Secondary | Influence on brain oxygen saturation | Influence of GDT on the frontal oxygen saturation of the brain assessed with Near-InfraRed-Spectroscopy (NIRS)-Monitoring | until discharge from recovery room/ICU | |
Secondary | Intra- and postoperative Measurements | Time until discharge, total fluids and amount of catecholamines administered, incidence of overall postoperative complications | Until discharge |
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