Alcohol Withdrawal DeliriumPhase 4NCT03877120
Treatment Of Alcohol Withdrawal Syndrome: Dexmedetomidine Vs Diazepam In A Hospital O'horán
A Phase 4 study testing Dexmedetomidine 0.004 MG/ML and Diazepam Injectable Solution in people with Alcohol Withdrawal Delirium, run by Centro Medico Nacional La Raza, IMSS at 1 site in Mexico.
Trial summary
The cessation of alcohol consumption of people suffering from alcohol abuse frequently leads to the development of an alcohol withdrawal syndrome (AWS). The ethylic suppression syndrome is defined as the appearance of two or more data of autonomic hyperactivity, nausea, hallucinations and seizures associated with the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Withdrawal Delirium
- What is being tested?
- Dexmedetomidine 0.004 MG/ML and Diazepam Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteMexico
- Study dates
- 1 Nov 2017to 31 Aug 2018
- Phase
- Phase 4
- 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
Who may be able to join
- Patients who received dexmedetomidine during their Emergency stay
- Patients who received diazepam during their Emergency stay
- CIE-10 codes consistent with alcohol withdrawal during hospitalization
- CIWA-A score >10 points
Who cannot join
- comorbid disease, including several with CNS trauma or cerebrovascular accidents, one with end-stage metastatic carcinoma, and one patient with severe sepsis.
Trial locations and contacts
1 site in 1 country.
About this study
The cessation of alcohol consumption of people suffering from alcohol abuse frequently leads to the development of an alcohol withdrawal syndrome (AWS).
The ethylic suppression syndrome is defined as the appearance of two or more data of autonomic hyperactivity, nausea, hallucinations and seizures associated with the cessation of alcohol consumption. For its evaluation, the CIWA-Ar scale is used, which guides the treatment based on benzodiazepines but with many adverse effects, so sedatives have been tried, among them dexmedetomidine, an alpha-agonist with action in the locus caeruleus, with variable results. Objectives: The investigators aimed to compare the DEX vs. Diazepam, for moderate disease, applying the CIWA-Ar scale, in participants with severe to moderate AWS. Methodology: 40 participants with CIWA-Ar greater than 10 points, the investigators are collected and randomized into two groups: one under treatment with diazepam (Group Diazepam) and another with dexmedetomidine (Group Dexmedetomidine), until the CIWA-Ar was reduced to less than 10, and adverse effects the investigators also reported. The analysis was done with student t. Results: The average duration of treatment with diazepam was 5.5 days (IC 95 = 6.6-3.8), the average duration of treatment with dexmedetomidine was 3.1 days (95% CI = 4.5-1.7), with a significant difference ( p = 0.0016). In the group with diazepam 60% presented adverse effects and in the group with dexmedetomidine 25% presented them, with a significant difference (p = 0.04). Conclusion: dexmedetomidine was superior to diazepam for the treatment of moderate-severe alcohol withdrawal with fewer adverse effects.
KEY WORDS: Alcohol dependence · Alcohol withdrawal syndrome · Dexmedetomidine · Diazepam · Benzodiazepines
Read the detailed description
Alcohol withdrawal syndrome AWS (Alcohol Withdrawal Syndrome), is defined as the appearance of two or more data of autonomic hyperactivity, nausea, hallucinations and seizures associated with cessation of alcohol consumption. For its evaluation, the CIWA-Ar (Clinical Institute Withdrawal Assessment for Alcohol) scale is used, which guides the treatment based on benzodiazepines but a disadvantage is the related adverse effects, for which other pharmacological strategies of sedation have been tried, among them Dexmedetomidine (DEX).
OBJECTIVES:
The investigators aimed to compare the DEX vs. Diazepam, for moderate disease, applying the CIWA-Ar scale, in participants with severe to moderate AWS (Alcohol Withdrawal Syndrome).
MATERIALS:
Prior authorization from the ethics committee of O'Horán Hospital, Yucatán, Mexico. No. Registration CEI-011-1-17, and signature of informed consent. A randomized clinical trial was carried out in the Adult Emergencies service during the period July 2017-July 2018. Forty participants with CIWA-Ar greater than 10 points participated. The administration of:
- Diazepam 5-20 mg IV. B) DEX 0.2-0.7 mcg / Kg / min., until the CIWA-Ar scale decreases to <10.
The investigators are excluded minor patients, mild CIWA-Ar category, previous medication, participants with severe cranial encephalic trauma (TBI) or mechanical ventilation requirement, with chronic liver failure category C in the Child-Turcotte-Pugh classification.
RESULTS
The CIWA Ar scale average for admission was 23 points, the lowest of 10 points and the highest of 38 points. The average number of days consuming alcohol prior to hospital admission was 131.9, with the highest average in the group that used dexmedetomidine; the average number of days after having suspended the intake until hospital admission was 1.7 days, being slightly higher in the group that used diazepam; the shortest time was 6 hours and the longest of a week without being related to the CIWA Ar score.
The average duration of treatment with diazepam was 5.5 days (IC 95 = 6.6-3.8), The average duration of treatment with dexmedetomidine was 3.1 days (95% CI = 4.5-1.7) After applying t student a significant difference was found in the number of days in favor of dexmedetomidine (p = 0.0016)
CONCLUSIONS
The investigators found that DEX at conventional doses, for the treatment of moderate-severe alcohol withdrawal in terms of reducing the CIWA-Ar scale, in fewer days and with fewer adverse effects and complications.
REFERENCES:
- Anderson P, Lars M, Gauden G. Alchol in the Europen Union. Consume, harm and policy approaches. Edit. WHO. 2012
- Nota descriptiva N° 349: Alcohol. Organización Mundial de la Salud. 2015.
- Encuesta Nacional de Adicciones 2011: Reporte de Alcohol. Medina-Mora ME, Villatoro-Velázquez JA, Fleiz-Bautista C, et. Al. México: INPRFM; 2012.
- Longo D, Fauci A, Kasper E, et al. Harrison: Principios de Medicina Interna. 18ª ed. McGraw-Hill. México. 2012.
- Diagnostic and statistical manual of mental disorders. 5th edition. Washington, DC: American Psychiatric Association; 2013. 947 pp.
- Carson L, Kumar N, Wong-Mckinstry. Alcohol Withdrawal Syndrome. Critical Care. 2012.
- Jawa R, Stothert J, Shostrom V, et al. Alcohol Withdrawal Syndrome in admitted trauma patients. The American Journal of Surgery (2014)208: 781-787
- Sullivan J, Sykora K, Schneiderman J, et al. Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar). Br J Addict. 1989. 84(11):1353-7.
- Waye C, Wong M, Lee S. Implementation of a CIWA Ar Alcohol Withdrawal protocol in a Veterans Hospital. South Med Jour. 2015. 108(1):23-8.
- Ramírez D, Sánchez G. Capacidad diagnóstica de las escalas de Cushman y AWS para supresión etílica. Med Int de Mex. 2013. 29(1): 26-31
- Miller W, McCurdy L. A double-blind comparison of the efficacy and safety of lorazepam and diazepam in the treatment of the acute alcohol withdrawal syndrome. Clin Ther 1984. 6(3):364-71.
- Henrey G, Dery R, Bandes R. A prospective randomized trial of phenobarbital vs benzodiazepines for acute alcohol withdrawal. Am Jour Eme Med. 2011. 382-85.
- Hughes D, VanWert E, LePori L. Propofol for benzodiazepine-refractory alcohol withdrawal in a non-mechanically ventilated patient. Am Jour Eme Med. 2014. 112.e3-e4.
- Wong A, et al. Multicenter evaluation of pharmacologic management and outcomes associated with severe resistant alcohol withdrawal. J Crit Care. 2014.
- Samuels E, Szabadi E. Functional Neuroanatomy of the Noradrenergic Locus Coeruleus: Its Roles in the Regulation of Arousal and Autonomic Function Part I: Principles of Functional Organisation. Curr Neuropharmacol. 2008; 6(3): 235-53.
- Rovasalo A, Tohmo H, Aantaa R, Kettunen E, Palojoki R: Dexmedetomidine as an adjuvant in the treatment of alcohol withdrawal delirium: a case report. Gen Hosp Psychiatr 2006, 28:362-363.
- Rayner et al. Dexmedetomidine as adjunct treatment for severe alcohol withdrawal. Annasl of intensive care. 2012. 2:12
- VanderWeid L, Foster C, McLaren R. Evaluation of early dexmedetomidine addition to the standard of care for severe alcohol withdrawal in the ICU: A retrospective controlled cohort study. Jour Int Care Med. 2014. 1-7.
- Frazee E, Personett H, Leung J, et al. Influence of dexmedetomidine therapy on the management of severe alcohol withdrawal síndrome in critically ill patients. Jour Crit Care. 2014. 198-302.
- Crispo A, Daley M, Pepin J. Comparison of clinical outcomes in nonintubated patients with severe alcohol withdrawal síndrome treated with continuous-infusion sedatives: dexmedetomidine versus benzodiazepines. Pharm. 2014. 910-17.
- Pita S. Determinación del tamaño muestreal. Cad Aten Prim. 1996. 138-44.
- Farmacología Básica y clínica. P Lorenzo, A Moreno, Lizasoain, et al. 18ª ed. Editorial Panamericana. España. 2010.
- Conditions
- Alcohol Withdrawal Delirium
- Being tested
- Dexmedetomidine 0.004 MG/ML, Diazepam Injectable Solution
- Keywords
- Dexmedetomidine, Diazepam, Alcohol dependence, Alcohol withdrawal syndrome, Benzodiacepines
- Medical subject headings
- Alcohol Withdrawal Delirium, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine 0.004 MG/MLDrug
Experimental studies and single case reports suggest the α2-agonist dexmedetomidine is effective in managing the autonomic symptoms seen with alcohol withdrawal.
Diazepam Injectable SolutionDrug
diazepam start with 5-20 mg IV as a dose response, steps until a maximum dose of 120 mg diazepam.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Sham comparator | Dexmedetomidine. Dexmedetomidine use 400 mcg in 100 cc 0.9% physiological solution in continuous infusion starting at a dose of 0.2 mcg / kg / hr titrating until reaching a decrease in the adrenergic response, with a maximum dose of 0.7 mcg / kg / hr7.
Dosage form: DEX 0.2-0.7 mcg/Kg/min. Receives: Drug: Dexmedetomidine 0.004 MG/ML |
| Diazepam | Active comparator | Dosage form: Diazepam 5-10 mg IV, steps until a maximum dose of 120 mg diazepam Receives: Drug: Diazepam Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Alcohol Withdrawal Scoring
Total Score = 0 - 9: absent or minimal withdrawal 10 - 19: mild to moderate withdrawal more than 20: severe withdrawal
Measured: dosing, total dose per 24 hours period for each patient, limited to 10 days
Average Diazepam Received (mg)
Dosis total: Diacepam 5-20 mg IV
Measured: Limited to 10 days
Average Dexmedetomidine Received (mg)
Infusión: DEX 0.2-0.7 mcg/Kg/min
Measured: dosing, total dose per 24 hours period for each patient, limited to 10 days
heart rate average
mean values per 24 hours period for each patient
Measured: 24 hours
Systolic blood pressure average
mean values per 24 hours period for each patient
Measured: 24hours
Secondary outcomes (1)
days of hospital stay
Duration in days of hospital stay
Measured: 24 hours limited to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start1 Nov 2017
- Primary completion28 Feb 2018
- Study completion31 Aug 2018
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 Alcohol Withdrawal DeliriumStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical Trials To compare Diazepam 5-20 mg IV or Dexmedetomidine 0.2-0.7 mcg / Kg / min., In monotherapy until the CIWA-Ar decreases to \<10.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Medico Nacional La Raza, IMSS
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de La Frontera
- Responsible party
- Principal investigator, GARCIA MENDEZ NAYELY, Centro Medico Nacional La Raza, IMSS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877120
- Sponsor's protocol ID
- CEI-011-1-17
- Status last verified
- Mar 2019
- First submitted
- 12 Mar 2019
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yost DA. Alcohol withdrawal syndrome. Am Fam Physician. 1996 Aug;54(2):657-64, 669.
PubMed 8701843Garcia-Mendez N, Briceno-Santana M, Totomoch-Serra A, Manterola C, Otzen T, Valdez PS, Campos-Duran R, Reyna GC. The hemodynamic effects of diazepam versus dexmedetomidine in the treatment of alcohol withdrawal syndrome: A randomized clinical trial. Med Clin (Barc). 2021 Dec 24;157(12):561-568. doi: 10.1016/j.medcli.2020.09.023. Epub 2021 Jan 8. English, Spanish.
PubMed 33423824
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Of Alcohol Withdrawal Syndrome: Dexmedetomidine Vs Diazepam In A Hospital O'horán
- ClinicalTrials.gov ID
- NCT03877120
- Acronym / sponsor ID
- CEI-011-1-17
- Conditions
- Alcohol Withdrawal Delirium
- Keywords
- Dexmedetomidine, Diazepam, Alcohol dependence, Alcohol withdrawal syndrome, Benzodiacepines
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Centro Medico Nacional La Raza, IMSSUniversity, hospital or other
- Collaborators
- Universidad de La Frontera
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 15 Mar 2019 (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.
The cessation of alcohol consumption of people suffering from alcohol abuse frequently leads to the development of an alcohol withdrawal syndrome (AWS).
The ethylic suppression syndrome is defined as the appearance of two or more data of autonomic hyperactivity, nausea, hallucinations and seizures associated with the cessation of alcohol consumption. For its evaluation, the CIWA-Ar scale is used, which guides the treatment based on benzodiazepines but with many adverse effects, so sedatives have been tried, among them dexmedetomidine, an alpha-agonist with action in the locus caeruleus, with variable results. Objectives: The investigators aimed to compare the DEX vs. Diazepam, for moderate disease, applying the CIWA-Ar scale, in participants with severe to moderate AWS. Methodology: 40 participants with CIWA-Ar greater than 10 points, the investigators are collected and randomized into two groups: one under treatment with diazepam (Group Diazepam) and another with dexmedetomidine (Group Dexmedetomidine), until the CIWA-Ar was reduced to less than 10, and adverse effects the investigators also reported. The analysis was done with student t. Results: The average duration of treatment with diazepam was 5.5 days (IC 95 = 6.6-3.8), the average duration of treatment with dexmedetomidine was 3.1 days (95% CI = 4.5-1.7), with a significant difference ( p = 0.0016). In the group with diazepam 60% presented adverse effects and in the group with dexmedetomidine 25% presented them, with a significant difference (p = 0.04). Conclusion: dexmedetomidine was superior to diazepam for the treatment of moderate-severe alcohol withdrawal with fewer adverse effects.
KEY WORDS: Alcohol dependence · Alcohol withdrawal syndrome · Dexmedetomidine · Diazepam · Benzodiazepines
Detailed description
Alcohol withdrawal syndrome AWS (Alcohol Withdrawal Syndrome), is defined as the appearance of two or more data of autonomic hyperactivity, nausea, hallucinations and seizures associated with cessation of alcohol consumption. For its evaluation, the CIWA-Ar (Clinical Institute Withdrawal Assessment for Alcohol) scale is used, which guides the treatment based on benzodiazepines but a disadvantage is the related adverse effects, for which other pharmacological strategies of sedation have been tried, among them Dexmedetomidine (DEX).
OBJECTIVES:
The investigators aimed to compare the DEX vs. Diazepam, for moderate disease, applying the CIWA-Ar scale, in participants with severe to moderate AWS (Alcohol Withdrawal Syndrome).
MATERIALS:
Prior authorization from the ethics committee of O'Horán Hospital, Yucatán, Mexico. No. Registration CEI-011-1-17, and signature of informed consent. A randomized clinical trial was carried out in the Adult Emergencies service during the period July 2017-July 2018. Forty participants with CIWA-Ar greater than 10 points participated. The administration of:
- Diazepam 5-20 mg IV. B) DEX 0.2-0.7 mcg / Kg / min., until the CIWA-Ar scale decreases to <10.
The investigators are excluded minor patients, mild CIWA-Ar category, previous medication, participants with severe cranial encephalic trauma (TBI) or mechanical ventilation requirement, with chronic liver failure category C in the Child-Turcotte-Pugh classification.
RESULTS
The CIWA Ar scale average for admission was 23 points, the lowest of 10 points and the highest of 38 points. The average number of days consuming alcohol prior to hospital admission was 131.9, with the highest average in the group that used dexmedetomidine; the average number of days after having suspended the intake until hospital admission was 1.7 days, being slightly higher in the group that used diazepam; the shortest time was 6 hours and the longest of a week without being related to the CIWA Ar score.
The average duration of treatment with diazepam was 5.5 days (IC 95 = 6.6-3.8), The average duration of treatment with dexmedetomidine was 3.1 days (95% CI = 4.5-1.7) After applying t student a significant difference was found in the number of days in favor of dexmedetomidine (p = 0.0016)
CONCLUSIONS
The investigators found that DEX at conventional doses, for the treatment of moderate-severe alcohol withdrawal in terms of reducing the CIWA-Ar scale, in fewer days and with fewer adverse effects and complications.
REFERENCES:
- Anderson P, Lars M, Gauden G. Alchol in the Europen Union. Consume, harm and policy approaches. Edit. WHO. 2012
- Nota descriptiva N° 349: Alcohol. Organización Mundial de la Salud. 2015.
- Encuesta Nacional de Adicciones 2011: Reporte de Alcohol. Medina-Mora ME, Villatoro-Velázquez JA, Fleiz-Bautista C, et. Al. México: INPRFM; 2012.
- Longo D, Fauci A, Kasper E, et al. Harrison: Principios de Medicina Interna. 18ª ed. McGraw-Hill. México. 2012.
- Diagnostic and statistical manual of mental disorders. 5th edition. Washington, DC: American Psychiatric Association; 2013. 947 pp.
- Carson L, Kumar N, Wong-Mckinstry. Alcohol Withdrawal Syndrome. Critical Care. 2012.
- Jawa R, Stothert J, Shostrom V, et al. Alcohol Withdrawal Syndrome in admitted trauma patients. The American Journal of Surgery (2014)208: 781-787
- Sullivan J, Sykora K, Schneiderman J, et al. Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar). Br J Addict. 1989. 84(11):1353-7.
- Waye C, Wong M, Lee S. Implementation of a CIWA Ar Alcohol Withdrawal protocol in a Veterans Hospital. South Med Jour. 2015. 108(1):23-8.
- Ramírez D, Sánchez G. Capacidad diagnóstica de las escalas de Cushman y AWS para supresión etílica. Med Int de Mex. 2013. 29(1): 26-31
- Miller W, McCurdy L. A double-blind comparison of the efficacy and safety of lorazepam and diazepam in the treatment of the acute alcohol withdrawal syndrome. Clin Ther 1984. 6(3):364-71.
- Henrey G, Dery R, Bandes R. A prospective randomized trial of phenobarbital vs benzodiazepines for acute alcohol withdrawal. Am Jour Eme Med. 2011. 382-85.
- Hughes D, VanWert E, LePori L. Propofol for benzodiazepine-refractory alcohol withdrawal in a non-mechanically ventilated patient. Am Jour Eme Med. 2014. 112.e3-e4.
- Wong A, et al. Multicenter evaluation of pharmacologic management and outcomes associated with severe resistant alcohol withdrawal. J Crit Care. 2014.
- Samuels E, Szabadi E. Functional Neuroanatomy of the Noradrenergic Locus Coeruleus: Its Roles in the Regulation of Arousal and Autonomic Function Part I: Principles of Functional Organisation. Curr Neuropharmacol. 2008; 6(3): 235-53.
- Rovasalo A, Tohmo H, Aantaa R, Kettunen E, Palojoki R: Dexmedetomidine as an adjuvant in the treatment of alcohol withdrawal delirium: a case report. Gen Hosp Psychiatr 2006, 28:362-363.
- Rayner et al. Dexmedetomidine as adjunct treatment for severe alcohol withdrawal. Annasl of intensive care. 2012. 2:12
- VanderWeid L, Foster C, McLaren R. Evaluation of early dexmedetomidine addition to the standard of care for severe alcohol withdrawal in the ICU: A retrospective controlled cohort study. Jour Int Care Med. 2014. 1-7.
- Frazee E, Personett H, Leung J, et al. Influence of dexmedetomidine therapy on the management of severe alcohol withdrawal síndrome in critically ill patients. Jour Crit Care. 2014. 198-302.
- Crispo A, Daley M, Pepin J. Comparison of clinical outcomes in nonintubated patients with severe alcohol withdrawal síndrome treated with continuous-infusion sedatives: dexmedetomidine versus benzodiazepines. Pharm. 2014. 910-17.
- Pita S. Determinación del tamaño muestreal. Cad Aten Prim. 1996. 138-44.
- Farmacología Básica y clínica. P Lorenzo, A Moreno, Lizasoain, et al. 18ª ed. Editorial Panamericana. España. 2010.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Clinical Trials To compare Diazepam 5-20 mg IV or Dexmedetomidine 0.2-0.7 mcg / Kg / min., In monotherapy until the CIWA-Ar decreases to <10.
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Sham comparator | Drug: Dexmedetomidine 0.004 MG/MLDexmedetomidine. Dexmedetomidine use 400 mcg in 100 cc 0.9% physiological solution in continuous infusion starting at a dose of 0.2 mcg / kg / hr titrating until reaching a decrease in the adrenergic response, with a maximum dose of 0.7 mcg / kg / hr7. Dosage form: DEX 0.2-0.7 mcg/Kg/min. |
| Diazepam | Active comparator | Drug: Diazepam Injectable SolutionDosage form: Diazepam 5-10 mg IV, steps until a maximum dose of 120 mg diazepam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who received dexmedetomidine during their Emergency stay
- Patients who received diazepam during their Emergency stay
- CIE-10 codes consistent with alcohol withdrawal during hospitalization
- CIWA-A score >10 points
Key exclusion criteria (1 listed)
- comorbid disease, including several with CNS trauma or cerebrovascular accidents, one with end-stage metastatic carcinoma, and one patient with severe sepsis.
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 |
|---|---|---|
| Dexmedetomidine 0.004 MG/MLExperimental studies and single case reports suggest the α2-agonist dexmedetomidine is effective in managing the autonomic symptoms seen with alcohol withdrawal. | Drug | Dexmedetomidine |
| Diazepam Injectable Solutiondiazepam start with 5-20 mg IV as a dose response, steps until a maximum dose of 120 mg diazepam. | Drug | Diazepam |
Primary outcome
Average Alcohol Withdrawal Scoring
Time frame: dosing, total dose per 24 hours period for each patient, limited to 10 days
Total Score = 0 - 9: absent or minimal withdrawal 10 - 19: mild to moderate withdrawal more than 20: severe withdrawal
Average Diazepam Received (mg)
Time frame: Limited to 10 days
Dosis total: Diacepam 5-20 mg IV
Average Dexmedetomidine Received (mg)
Time frame: dosing, total dose per 24 hours period for each patient, limited to 10 days
Infusión: DEX 0.2-0.7 mcg/Kg/min
heart rate average
Time frame: 24 hours
mean values per 24 hours period for each patient
Systolic blood pressure average
Time frame: 24hours
mean values per 24 hours period for each patient
1 secondary outcome
days of hospital stay
Time frame: 24 hours limited to 10 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 15 Mar 2019.
- Results publication: PubMed 8701843Yost DA. Alcohol withdrawal syndrome. Am Fam Physician. 1996 Aug;54(2):657-64, 669.
- Derived from this study: PubMed 33423824Garcia-Mendez N, Briceno-Santana M, Totomoch-Serra A, Manterola C, Otzen T, Valdez PS, Campos-Duran R, Reyna GC. The hemodynamic effects of diazepam versus dexmedetomidine in the treatment of alcohol withdrawal syndrome: A randomized clinical trial. Med Clin (Barc). 2021 Dec 24;157(12):561-568. doi: 10.1016/j.medcli.2020.09.023. Epub 2021 Jan 8. English, Spanish.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine 0.004 MG/ML and Diazepam Injectable Solution in people with Alcohol Withdrawal Delirium, run by Centro Medico Nacional La Raza, IMSS at 1 site in Mexico.
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 1 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 15 Mar 2019. 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 Mexico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Average Alcohol Withdrawal Scoring (time frame: dosing, total dose per 24 hours period for each patient, limited to 10 days). The study lists 5 primary outcomes in all. 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 NCT03877120, 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 15 Mar 2019.