CAM-ICU Diagnosed Delirium Clinical Trial
Official title:
Monocenter, Double Blind, Randomised, Placebo Controlled Study to Evaluate Physostigmine for the Treatment of Delirium in Perioperative Intensive Care Medicine
Evaluation if physostigmine reduces symptoms in patients who has developed a delirium in Intensive care after a surgery
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | December 2018 |
| Est. primary completion date | December 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility |
Inclusion Criteria: - Patients of both genders aged > 18 years, < 85 years of ICU C1 after elective or emergency heart surgery with or without extracorporeal circulation (heart-lung machine and/or extracorporeal membrane oxygenation), with suspected delirium. (May be suspected if a patient does not show adequate improvement of vigilance 24 h after adequate reduction or stop of sedative medicine) - Patients (>18a, <85a) with CAM-ICU diagnosed delirium - Patients of legal capacity and patients with appointed representative Exclusion Criteria: - Asthma - hypersensitivity against Physostigmine salicylate, Sodium metabisulfite, Nitrogen - gangrene mechanical obstipation - mechanical urinary retention - Dystrophia myotonica - Depolarization block after depolarising muscle relaxants - Intoxications with "irreversibly acting" cholinesterase inhibitors - closed head trauma - obstructions at gastro-intestinal tract and at urinary tract - neurological diseases - left ventricular ejection fraction < 40% - Simultaneous Participation in other clinical trials or participation ind other clinical trials in the last 30 days - untreated coronary heart disease - wish to have children, pregnancy or nursing - patients with addictive disorder in medical history |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy | Frankfurt | Hessia |
| Lead Sponsor | Collaborator |
|---|---|
| PD Dr. Bertram Scheller | Dr. Franz Köhler Chemie GmbH (study medication and labeling), University Hospital, Frankfurt |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | change of vigilance or symptoms of the delirium measured by Richmond Agitation Sedation Score (RASS) | baseline to 48 hours after administration | ||
| Secondary | reduction of weaning time at mechanical ventilator of patients with symptoms of delirium | baseline to 48 hours after administration | ||
| Secondary | change in the spontaneous EEG and auditory evoked potentials | for the spontaneous EEG, we expect a shift in the frequency characteristics, measure is the spectrogram, more precisely the amplitude per frequency (band) and the phase information derived via Fourier Transform and Wavelet transformation The paradigm of the auditory stimulation is a roving paradigm (Science 13 May 2011: Vol. 332 no. 6031 pp. 858-862 DOI: 10.1126/science.1202043 •Report Preserved Feedforward But Impaired Top-Down Processes in the Vegetative State Melanie Boly1,2,*, Marta Isabel Garrido2, Olivia Gosseries1, Marie-Aurélie Bruno1, Pierre Boveroux3, Caroline Schnakers1, Marcello Massimini4, Vladimir Litvak2, Steven Laureys1, Karl Friston2) Measures will be differences in the mismatch negativity and in the phase synchronization between electrodes |
baseline to 48 hours after administration | |
| Secondary | impact of the variability of heart rate | heart rate variability is a dimensionless parameter, assessing the variability of the heart rate from ECG measures (Heart Rate Variability Conny M. A. van Ravenswaaij-Arts, MD; Louis A. A. Kollee, MD, PhD; Jeroen C. W. Hopman, MSc; Gerard B. A. Stoelinga, MD, PhD; and Herman P. van Geijn, MD, PhD [+-] Article and Author Information Ann Intern Med. 1993;118(6):436-447. doi:10.7326/0003-4819-118-6-199303150-00008 ) |
baseline to 48 hours | |
| Secondary | change in development of muscular force | muscular force is measured with a force gauge, measured in [Newton] | baseline up to 48 hours | |
| Secondary | Occurence of Adverse events | baseline to 4 weeks after treatment |