Suspected Delirium After Elective or Emergency Heart SurgeryPhase 3NCT02216266
Evaluation if Physostigmine Reduces Symptoms in Patients Who Has Developed a Delirium in Intensive Care After a Surgery
A Phase 3 study testing Physostigmine and Sodium Chloride solution in people with Suspected Delirium After Elective or Emergency Heart Surgery and CAM-ICU Diagnosed Delirium, run by PD Dr. Bertram Scheller at 1 site in Germany.
Trial summary
Evaluation if physostigmine reduces symptoms in patients who has developed a delirium in Intensive care after a surgery Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Suspected Delirium After Elective or Emergency Heart Surgery, CAM-ICU Diagnosed Delirium
- What is being tested?
- Physostigmine and Sodium Chloride solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2014to Dec 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Asthma
- hypersensitivity against Physostigmine salicylate, Sodium metabisulfite, Nitrogen
- gangrene mechanical obstipation
- mechanical urinary retention
- Dystrophia myotonica
- Depolarization block after depolarising muscle relaxants
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Bertram Scheller, MD contact
Germany1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy
Frankfurt, Hessia, 60590
Bertram Scheller, MD
About this study
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
- Being tested
- Physostigmine, Sodium Chloride solution
- Keywords
- Delirium, CAM-ICU
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysostigmineDrug
Also called Anticholium
Sodium Chloride solutionOther
Also called NaCl solution as Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Physostigmine | Active comparator | Physostigmine administered intravenously at a dose of 24 mg + 25 min a 0,04 mg/kg milligram(s)/kilogram Receives: Drug: Physostigmine |
| Sodium Chloride solution | Placebo comparator | solution administered intravenously 24 mg + 25 min a 0,04 mg/kg milligram(s)/kilogram Receives: Other: Sodium Chloride solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of vigilance or symptoms of the delirium measured by Richmond Agitation Sedation Score (RASS)
Measured: baseline to 48 hours after administration
Secondary outcomes (5)
reduction of weaning time at mechanical ventilator of patients with symptoms of delirium
Measured: baseline to 48 hours after administration
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
Measured: baseline to 48 hours after administration
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 )
Measured: baseline to 48 hours
change in development of muscular force
muscular force is measured with a force gauge, measured in [Newton]
Measured: baseline up to 48 hours
Occurence of Adverse events
Measured: baseline to 4 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suspected Delirium After Elective or Emergency Heart SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PD Dr. Bertram Scheller
- Sponsor type
- University, hospital or other
- Collaborators
- Goethe University, Dr. Franz Köhler Chemie GmbH (study medication and labeling)
- Responsible party
- Sponsor-investigator, PD Dr. Bertram Scheller, Johann Wolfgang Goethe University Hospital
- Investigators
- Bertram Scheller, MD, Principal investigator, Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy of Goethe-University Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216266
- Sponsor's protocol ID
- DELIcu
- Other IDs
- 2012-004082-41
- Status last verified
- Mar 2017
- First submitted
- 17 Oct 2013
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocenter, Double Blind, Randomised, Placebo Controlled Study to Evaluate Physostigmine for the Treatment of Delirium in Perioperative Intensive Care Medicine
- ClinicalTrials.gov ID
- NCT02216266
- Acronym / sponsor ID
- DELIcu
- Keywords
- Delirium, CAM-ICU
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- PD Dr. Bertram SchellerUniversity, hospital or other
- Collaborators
- Goethe University, Dr. Franz Köhler Chemie GmbH (study medication and labeling)
- Study start
- Apr 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 13 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation if physostigmine reduces symptoms in patients who has developed a delirium in Intensive care after a surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physostigmine | Active comparator | Drug: PhysostigminePhysostigmine administered intravenously at a dose of 24 mg + 25 min a 0,04 mg/kg milligram(s)/kilogram |
| Sodium Chloride solution | Placebo comparator | Other: Sodium Chloride solutionsolution administered intravenously 24 mg + 25 min a 0,04 mg/kg milligram(s)/kilogram |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- Asthma
- hypersensitivity against Physostigmine salicylate, Sodium metabisulfite, Nitrogen
- gangrene mechanical obstipation
- mechanical urinary retention
- Dystrophia myotonica
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhysostigmineAlso: Anticholium | Drug | Physostigmine |
| Sodium Chloride solutionAlso: NaCl solution as Placebo comparator | Other | Sodium Chloride solution |
Primary outcome
change of vigilance or symptoms of the delirium measured by Richmond Agitation Sedation Score (RASS)
Time frame: baseline to 48 hours after administration
5 secondary outcomes
reduction of weaning time at mechanical ventilator of patients with symptoms of delirium
Time frame: baseline to 48 hours after administration
change in the spontaneous EEG and auditory evoked potentials
Time frame: baseline to 48 hours after administration
impact of the variability of heart rate
Time frame: baseline to 48 hours
change in development of muscular force
Time frame: baseline up to 48 hours
Occurence of Adverse events
Time frame: baseline to 4 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertram Scheller, MD contact
Bertram Scheller, MD principal investigator
Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy of Goethe-University Frankfurt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Physostigmine and Sodium Chloride solution in people with Suspected Delirium After Elective or Emergency Heart Surgery and CAM-ICU Diagnosed Delirium, run by PD Dr. Bertram Scheller at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bertram Scheller, MD (bertram.scheller@kgu.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of vigilance or symptoms of the delirium measured by Richmond Agitation Sedation Score (RASS) (time frame: baseline to 48 hours after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2017.