Substance Withdrawal SyndromeWAAICUPNCT02318290
Opioids Withdrawal Syndrome in Critically Ill Patients: a Multicenter Prospective Cohort Study
An observational study of Substance Withdrawal Syndrome, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
Trial summary
Critically ill patients who are mechanically ventilated may require prolonged administration of sedatives and analgesics. Their prolonged use has been associated with withdrawal symptoms upon rapid weaning in critically ill patients. These withdrawal symptoms may be associated with adverse clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Withdrawal Syndrome
- What is being tested?
- Opiates
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2015to Dec 2015
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients under mechanical ventilation and receiving regular intermittent use or continuous infusion opioids for at least 96 hours
Who may be able to join
- intermittent use or continuous infusion opioids for at least 96 hours
Who cannot join
- Patient and/or relatives unable to communicate in French or English
- Patients unable to communicate (consent form and evaluation)
- Patient deaf without appropriate hearing aid
- Patients unable to communicate (consent form and evaluation)
- Imminent and predictable death according to medical team
- Severe brain injury, defined as Glasgow Coma Scale (GCS) score of 8 or less at ICU admission
Show all 17Show fewer
- Moderate brain injury, defined as GCS between 9 and 12, with elevated intracranial pressure (ICP > 20 mm Hg) who requires ICP monitoring and osmotherapy
- Major confounding factors for withdrawal syndrome by causing shivering, sympathetic drive and autonomic disorders
- Underlying active neurological condition (status epilepticus, encephalopathy, hypoxia)
- Neurological problems are covariates, which would make the assessment of sedation or IWS difficult Patient previously included in the study at any of the two hospitals (readmission to the ICU at a later date during the period of recruitment for the study, limiting to 1 weaning episode per patient)
- Thoracic and cervical spinal cord injury
- Adrenergic response to pain will be difficult to assess
- Unable to assess validated tool: DSM-V, RASS, CAM-ICU
- Narcotic
- If the underlying neurological condition resolves within the 96 hours, the patient may be included in the study
- Substance abuse prior to ICU admission (28)
- Chronic alcohol use defined as alcohol consumption of more than 2 drinks per day and/or more than 14 drinks per week for men and 9 drinks per week for woman as reported by family or as per patient's medical record
Trial locations and contacts
1 site in 1 country.
About this study
Critically ill patients who are mechanically ventilated may require prolonged administration of sedatives and analgesics. Their prolonged use has been associated with withdrawal symptoms upon rapid weaning in critically ill patients. These withdrawal symptoms may be associated with adverse clinical outcomes. Although well studied in the paediatric population, little is known about the epidemiology, risk factors and optimal screening methods in adults. Studying this problem is essential as we strive to develop proper weaning strategies.
Methods: Prospective observational two-center study in critically ill adult patients Objectives: 1) Describe the incidence of iatrogenic withdrawal of sedatives and analgesics in critically ill adult patients and 2) Evaluate the performance of screening tools assessing withdrawal that were developed for the paediatric patient in the adult population.
Read the detailed description
The objectives of the study are: 1) to describe the incidence of iatrogenic withdrawal of sedatives and analgesics in critically ill adult patients and; 2) Validate screening tools for withdrawal in the adult population.
Hypothesis
- Symptoms of iatrogenic benzodiazepines and opioids withdrawal occur commonly in mechanically ventilated patients exposed to high doses and/or prolonged infusions and who are rapidly weaned from these therapies.
- The scales for benzodiazepine and narcotic withdrawal detection used in paediatrics population correlate well with the DSM V diagnosis of withdrawal in an adult ICU population
- Major risk factors for withdrawal symptoms include longer duration of therapy and higher doses and admission for a medical condition (MICU)
Methods
A prospective multicenter observational study will be carried out in two University-affiliated hospital intensive care units (Hôpital du Sacré-Coeur and Montreal General Hospital). All mechanically ventilated ICU patients receiving continuous infusions of benzodiazepines and/or opioids for more than 96 hours will be prospectively screened daily for withdrawal symptoms by an intensivist. Withdrawal symptoms for opioid and benzodiazepines will be identified using the DSM-V criteria. Patients with moderate to severe head trauma, a severe neurological disease, or prior to admission substance abuse (significant alcohol, illicit or prescription drugs) will be excluded. We will also exclude patients with a regularly prescribed chronic opioid or benzodiazepine use prior to ICU admission. Risk factors for withdrawal including type of agents exposed, dosing, duration of exposure, weaning of agents, organ dysfunction, age, gender, smoking, severity of disease and admission diagnosis will be prospectively collected. The Withdrawal Assessment Tool-1 (WAT-1), a screening tools validated in the paediatric population, will also be administered daily. The criterion validity of this screening tool will be compared to the DSM-V criteria.
- Conditions
- Substance Withdrawal Syndrome
- Being tested
- Opiates
- Keywords
- Analgesia, Critical Care, Hypnotics and Sedatives
- Medical subject headings
- Substance Withdrawal Syndrome, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OpiatesDrug
Also called Analgesics, Narcotics
Mechanically ventilated patients receiving opiates for more than 96 hours will be evaluated for withdrawal symptoms upon weaning of the opiates
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients | Mechanically ventilated critically ill patients receiveing opiates for more than 96 hours will be prospectively followed for the emergence of withdrawal symptoms upon weaning of opiates Receives: Drug: Opiates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opiate withdrawal according to DSM V critieria
Opiate withdrawal as evaluated by an intensivist using DSM V criteria
Measured: From ICU admission to 48 hours post-extubation or a maximum of 14 days passed since the beginning of the initial weaning process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Substance Withdrawal SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Williamson, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Investigators
- David Williamson, Ph.D., Principal investigator, Hopital du Sacre-Coeur de MontréalMarc Perreaut, Pharm.D., Principal investigator, Montreal General HospitalAnne Julie Frenette, M.Sc., Principal investigator, Hopital du Sacre-Coeur de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318290
- Sponsor's protocol ID
- 2014-1112
- Acronym
- WAAICUP
- Status last verified
- Feb 2016
- First submitted
- 9 Dec 2014
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Cammarano WB, Pittet JF, Weitz S, Schlobohm RM, Marks JD. Acute withdrawal syndrome related to the administration of analgesic and sedative medications in adult intensive care unit patients. Crit Care Med. 1998 Apr;26(4):676-84. doi: 10.1097/00003246-199804000-00015.
PubMed 9559604Franck LS, Harris SK, Soetenga DJ, Amling JK, Curley MA. The Withdrawal Assessment Tool-1 (WAT-1): an assessment instrument for monitoring opioid and benzodiazepine withdrawal symptoms in pediatric patients. Pediatr Crit Care Med. 2008 Nov;9(6):573-80. doi: 10.1097/PCC.0b013e31818c8328.
PubMed 18838937
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioids Withdrawal Syndrome in Critically Ill Patients: a Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02318290
- Acronym / sponsor ID
- WAAICUP / 2014-1112
- Conditions
- Substance Withdrawal Syndrome
- Keywords
- Analgesia, Critical Care, Hypnotics and Sedatives
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Dec 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.
Critically ill patients who are mechanically ventilated may require prolonged administration of sedatives and analgesics. Their prolonged use has been associated with withdrawal symptoms upon rapid weaning in critically ill patients. These withdrawal symptoms may be associated with adverse clinical outcomes. Although well studied in the paediatric population, little is known about the epidemiology, risk factors and optimal screening methods in adults. Studying this problem is essential as we strive to develop proper weaning strategies.
Methods: Prospective observational two-center study in critically ill adult patients Objectives: 1) Describe the incidence of iatrogenic withdrawal of sedatives and analgesics in critically ill adult patients and 2) Evaluate the performance of screening tools assessing withdrawal that were developed for the paediatric patient in the adult population.
Detailed description
The objectives of the study are: 1) to describe the incidence of iatrogenic withdrawal of sedatives and analgesics in critically ill adult patients and; 2) Validate screening tools for withdrawal in the adult population.
Hypothesis
- Symptoms of iatrogenic benzodiazepines and opioids withdrawal occur commonly in mechanically ventilated patients exposed to high doses and/or prolonged infusions and who are rapidly weaned from these therapies.
- The scales for benzodiazepine and narcotic withdrawal detection used in paediatrics population correlate well with the DSM V diagnosis of withdrawal in an adult ICU population
- Major risk factors for withdrawal symptoms include longer duration of therapy and higher doses and admission for a medical condition (MICU)
Methods
A prospective multicenter observational study will be carried out in two University-affiliated hospital intensive care units (Hôpital du Sacré-Coeur and Montreal General Hospital). All mechanically ventilated ICU patients receiving continuous infusions of benzodiazepines and/or opioids for more than 96 hours will be prospectively screened daily for withdrawal symptoms by an intensivist. Withdrawal symptoms for opioid and benzodiazepines will be identified using the DSM-V criteria. Patients with moderate to severe head trauma, a severe neurological disease, or prior to admission substance abuse (significant alcohol, illicit or prescription drugs) will be excluded. We will also exclude patients with a regularly prescribed chronic opioid or benzodiazepine use prior to ICU admission. Risk factors for withdrawal including type of agents exposed, dosing, duration of exposure, weaning of agents, organ dysfunction, age, gender, smoking, severity of disease and admission diagnosis will be prospectively collected. The Withdrawal Assessment Tool-1 (WAT-1), a screening tools validated in the paediatric population, will also be administered daily. The criterion validity of this screening tool will be compared to the DSM-V criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients | – | Drug: OpiatesMechanically ventilated critically ill patients receiveing opiates for more than 96 hours will be prospectively followed for the emergence of withdrawal symptoms upon weaning of opiates |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients under mechanical ventilation and receiving regular intermittent use or continuous infusion opioids for at least 96 hours
Key inclusion criteria (1 listed)
- intermittent use or continuous infusion opioids for at least 96 hours
Key exclusion criteria (17 listed)
- Patient and/or relatives unable to communicate in French or English
- Patients unable to communicate (consent form and evaluation)
- Patient deaf without appropriate hearing aid
- Patients unable to communicate (consent form and evaluation)
- Imminent and predictable death according to medical team
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 |
|---|---|---|
| OpiatesAlso: Analgesics, NarcoticsMechanically ventilated patients receiving opiates for more than 96 hours will be evaluated for withdrawal symptoms upon weaning of the opiates | Drug | Critically ill patients |
Primary outcome
Opiate withdrawal according to DSM V critieria
Time frame: From ICU admission to 48 hours post-extubation or a maximum of 14 days passed since the beginning of the initial weaning process
Opiate withdrawal as evaluated by an intensivist using DSM V criteria
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
- Background: PubMed 9559604Cammarano WB, Pittet JF, Weitz S, Schlobohm RM, Marks JD. Acute withdrawal syndrome related to the administration of analgesic and sedative medications in adult intensive care unit patients. Crit Care Med. 1998 Apr;26(4):676-84. doi: 10.1097/00003246-199804000-00015.
- Background: PubMed 18838937Franck LS, Harris SK, Soetenga DJ, Amling JK, Curley MA. The Withdrawal Assessment Tool-1 (WAT-1): an assessment instrument for monitoring opioid and benzodiazepine withdrawal symptoms in pediatric patients. Pediatr Crit Care Med. 2008 Nov;9(6):573-80. doi: 10.1097/PCC.0b013e31818c8328.
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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.
David Williamson, Ph.D. principal investigator
Hopital du Sacre-Coeur de Montréal
Marc Perreaut, Pharm.D. principal investigator
Montreal General Hospital
Anne Julie Frenette, M.Sc. principal investigator
Hopital du Sacre-Coeur de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Withdrawal Syndrome, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
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 1 inclusion and 17 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: finished, as of the sponsor's last update on 19 Feb 2016. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opiate withdrawal according to DSM V critieria (time frame: From ICU admission to 48 hours post-extubation or a maximum of 14 days passed since the beginning of the initial weaning process). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02318290, which also lists 2 linked publications.
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 19 Feb 2016.