Substance Withdrawal SyndromeNCT03374722
Opioid Withdrawal Symptoms in Critically Ill Patients
An observational study of Substance Withdrawal Syndrome and Critical Illness, run by Mahidol University at 1 site in Thailand.
Trial summary
Most critically ill patients encounter pain and distress from acute illness, medical procedures and devices as well as routine care in the intensive care units (ICU). Opioids are principal analgesics that alleviate moderate to severe pain and facilitate patients to co-operate the course of treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Substance Withdrawal Syndrome, Critical Illness
- What is being tested?
- Opioids
- Type of treatment
- Injection or infusion
- How many people
- 55 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2018to 7 Oct 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Intensive care units
Who may be able to join
- Age ≥18 years
- On mechanical ventilator at least 24 hours
- Received continuous infusion of opioid at least 24 hours
- Patient or legal surrogate who is willing and able to provide written informed consent and comply with all protocol requirements
Who cannot join
- Severely disturbed behavior pattern on account of underlying neurological disease (status epilepticus, encephalopathy, head trauma, brain injury, spinal cord injury)
- Preexisting psychiatric diagnosis
- Substance abuse prior to ICU admission
- Chronic alcohol drinking
- Pregnancy
- End-of-life care
- Death during ICU admission or during opioid IV infusion
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Pharmacy, Mahidol University
Ratchathewi, Bangkok, 10400
About this study
Most critically ill patients encounter pain and distress from acute illness, medical procedures and devices as well as routine care in the intensive care units (ICU). Opioids are principal analgesics that alleviate moderate to severe pain and facilitate patients to co-operate the course of treatment. However, prolong administration of opioids especially in mechanically ventilated patients can cause withdrawal symptoms if analgesics are rapidly weaning or acutely disruption. The opioid withdrawal symptoms (OWS) are well reported in critically ill children that cause discomfort and prolong weaning from mechanical ventilation. Weaning opioids and treatment of withdrawal symptoms are needed in order to decrease ventilator days, ICU and hospital length of stay. Conversely, there is lack of knowledge about incidence, clinical presentation, time course and appropriated assessment tool for withdrawal detection. Therefore, we conduct the study to explore an incidence of OWS, to identify factors associated OWS, to establish the assessment tool for OWS, and to report efficacy of the pharmacological treatment for OWS, in adult critically ill patients.
Read the detailed description
The primary objective of the study is to explore incidence of OWS in adult critically ill patients. The secondary objectives are 1) to identify factor associated OWS, 2) establish the assessment tool for OWS for adults and 3) to report efficacy of the pharmacological treatment in OWS in adults patients.
- Conditions
- Substance Withdrawal Syndrome, Critical Illness
- Being tested
- Opioids
- Medical subject headings
- Substance Withdrawal Syndrome, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OpioidsDrug
Mechanically ventilated critically ill patients who receive continuous opioid infusion for more than 24 hours will be observed for withdrawal symptoms when rate of opioid infusion is disrupted or decreased
| Study group | Role | What they receive |
|---|---|---|
| Mechanically ventilated critically ill patients | Mechanically ventilated critically ill patients who receive opioid as continuous infusion for more than 24 hours Receives: Drug: Opioids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of opioid withdrawal symptoms
Incidence of opioid withdrawal symptoms detected by self-developed assessment tool or the Diagnostic and Statistical Manual 5th edition (DSM-V)
Measured: 0, 1, 3, 6, 24 and 72 hour after reduction or discontinuation of intravenous opioid
Secondary outcomes (3)
Weaning days
Time from initial weaning from mechanical ventilator until extubation
Measured: 28 days
Ventilator days
Time from intubation until extubation
Measured: 28 days
ICU length of stay
Time from admission to ICU until discharge from ICU
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start1 Jan 2018
- Primary completion31 Aug 2018
- Study completion7 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Substance Withdrawal SyndromeStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suthinee Taesotikul, Mahidol University
- Investigators
- Suthinee Taesotikul, Pharm.D., Principal investigator, Faculty of Pharmacy, Mahidol university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374722
- Sponsor's protocol ID
- 10-60-68
- Status last verified
- Oct 2018
- First submitted
- 12 Dec 2017
- Last updated
- 9 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang PP, Huang E, Feng X, Bray CA, Perreault MM, Rico P, Bellemare P, Murgoi P, Gelinas C, Lecavalier A, Jayaraman D, Frenette AJ, Williamson D. Opioid-associated iatrogenic withdrawal in critically ill adult patients: a multicenter prospective observational study. Ann Intensive Care. 2017 Sep 2;7(1):88. doi: 10.1186/s13613-017-0310-5.
PubMed 28866754Korak-Leiter M, Likar R, Oher M, Trampitsch E, Ziervogel G, Levy JV, Freye EC. Withdrawal following sufentanil/propofol and sufentanil/midazolam. Sedation in surgical ICU patients: correlation with central nervous parameters and endogenous opioids. Intensive Care Med. 2005 Mar;31(3):380-7. doi: 10.1007/s00134-005-2579-3. Epub 2005 Feb 16.
PubMed 15714323Brown C, Albrecht R, Pettit H, McFadden T, Schermer C. Opioid and benzodiazepine withdrawal syndrome in adult burn patients. Am Surg. 2000 Apr;66(4):367-70; discussion 370-1.
PubMed 10776874Cammarano 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 9559604Taesotikul S, Dilokpattanamongkol P, Tangsujaritvijit V, Suthisisang C. Incidence and clinical manifestation of iatrogenic opioid withdrawal syndrome in mechanically ventilated patients. Curr Med Res Opin. 2021 Jul;37(7):1213-1219. doi: 10.1080/03007995.2021.1928616. Epub 2021 May 25.
PubMed 33966568
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Withdrawal Symptoms in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03374722
- Acronym / sponsor ID
- 10-60-68
- Conditions
- Substance Withdrawal Syndrome, Critical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 7 Oct 2018 (actual)
- First posted
- 15 Dec 2017 (actual)
- 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.
Most critically ill patients encounter pain and distress from acute illness, medical procedures and devices as well as routine care in the intensive care units (ICU). Opioids are principal analgesics that alleviate moderate to severe pain and facilitate patients to co-operate the course of treatment. However, prolong administration of opioids especially in mechanically ventilated patients can cause withdrawal symptoms if analgesics are rapidly weaning or acutely disruption. The opioid withdrawal symptoms (OWS) are well reported in critically ill children that cause discomfort and prolong weaning from mechanical ventilation. Weaning opioids and treatment of withdrawal symptoms are needed in order to decrease ventilator days, ICU and hospital length of stay. Conversely, there is lack of knowledge about incidence, clinical presentation, time course and appropriated assessment tool for withdrawal detection. Therefore, we conduct the study to explore an incidence of OWS, to identify factors associated OWS, to establish the assessment tool for OWS, and to report efficacy of the pharmacological treatment for OWS, in adult critically ill patients.
Detailed description
The primary objective of the study is to explore incidence of OWS in adult critically ill patients. The secondary objectives are 1) to identify factor associated OWS, 2) establish the assessment tool for OWS for adults and 3) to report efficacy of the pharmacological treatment in OWS in adults patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanically ventilated critically ill patients | – | Drug: OpioidsMechanically ventilated critically ill patients who receive opioid as continuous infusion for more than 24 hours |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Intensive care units
Key inclusion criteria (4 listed)
- Age ≥18 years
- On mechanical ventilator at least 24 hours
- Received continuous infusion of opioid at least 24 hours
- Patient or legal surrogate who is willing and able to provide written informed consent and comply with all protocol requirements
Key exclusion criteria (7 listed)
- Severely disturbed behavior pattern on account of underlying neurological disease (status epilepticus, encephalopathy, head trauma, brain injury, spinal cord injury)
- Preexisting psychiatric diagnosis
- Substance abuse prior to ICU admission
- Chronic alcohol drinking
- Pregnancy
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 |
|---|---|---|
| OpioidsMechanically ventilated critically ill patients who receive continuous opioid infusion for more than 24 hours will be observed for withdrawal symptoms when rate of opioid infusion is disrupted or decreased | Drug | Mechanically ventilated critically ill patients |
Primary outcome
Incidence of opioid withdrawal symptoms
Time frame: 0, 1, 3, 6, 24 and 72 hour after reduction or discontinuation of intravenous opioid
Incidence of opioid withdrawal symptoms detected by self-developed assessment tool or the Diagnostic and Statistical Manual 5th edition (DSM-V)
3 secondary outcomes
Weaning days
Time frame: 28 days
Ventilator days
Time frame: 28 days
ICU length of stay
Time frame: 28 days
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 9 Oct 2018.
- Results publication: PubMed 28866754Wang PP, Huang E, Feng X, Bray CA, Perreault MM, Rico P, Bellemare P, Murgoi P, Gelinas C, Lecavalier A, Jayaraman D, Frenette AJ, Williamson D. Opioid-associated iatrogenic withdrawal in critically ill adult patients: a multicenter prospective observational study. Ann Intensive Care. 2017 Sep 2;7(1):88. doi: 10.1186/s13613-017-0310-5.
- Results publication: PubMed 15714323Korak-Leiter M, Likar R, Oher M, Trampitsch E, Ziervogel G, Levy JV, Freye EC. Withdrawal following sufentanil/propofol and sufentanil/midazolam. Sedation in surgical ICU patients: correlation with central nervous parameters and endogenous opioids. Intensive Care Med. 2005 Mar;31(3):380-7. doi: 10.1007/s00134-005-2579-3. Epub 2005 Feb 16.
- Results publication: PubMed 10776874Brown C, Albrecht R, Pettit H, McFadden T, Schermer C. Opioid and benzodiazepine withdrawal syndrome in adult burn patients. Am Surg. 2000 Apr;66(4):367-70; discussion 370-1.
- Results publication: 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.
- Derived from this study: PubMed 33966568Taesotikul S, Dilokpattanamongkol P, Tangsujaritvijit V, Suthisisang C. Incidence and clinical manifestation of iatrogenic opioid withdrawal syndrome in mechanically ventilated patients. Curr Med Res Opin. 2021 Jul;37(7):1213-1219. doi: 10.1080/03007995.2021.1928616. Epub 2021 May 25.
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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.
Suthinee Taesotikul, Pharm.D. principal investigator
Faculty of Pharmacy, Mahidol university
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 and Critical Illness, run by Mahidol University at 1 site in Thailand.
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 4 inclusion and 7 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 9 Oct 2018. 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 Thailand. 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?
Incidence of opioid withdrawal symptoms (time frame: 0, 1, 3, 6, 24 and 72 hour after reduction or discontinuation of intravenous opioid). 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 NCT03374722, which also lists 5 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 9 Oct 2018.