Alcohol WithdrawalPhase 4PARTINCT04156464
Phenobarbital vs Ativan for Alcohol Withdrawal in the Intensive Care Unit
A Phase 4 study testing Phenobarbital and Lorazepam in people with Alcohol Withdrawal and Alcohol Withdrawal Delirium, run by OSF Healthcare System at 1 site in United States.
Trial summary
Our aim is to compare outcomes of patients with benzodiazepine-refractory alcohol withdrawal syndrome who are treated with either a phenobarbital-based or a lorazepam based protocol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Withdrawal, Alcohol Withdrawal Delirium
- What is being tested?
- Phenobarbital and Lorazepam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2020to 1 Mar 2022
- 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 will be eligible for randomization if he/she has met one of the following three conditions:
- has required more than 10 mg of lorazepam within a one hour time period,
- has required more than 30 mg of lorazepam within a four hour time period, or
- requires admission/transfer to the intensive care unit for primarily uncontrolled alcohol withdrawal symptoms
Who cannot join
- Patients will be excluded from the study if he/she:
- has a traumatic brain injury or other neurological condition requiring frequent neurological assessment (stroke, intracranial hemorrhage, active seizures on admission)
- has severe hypotension requiring vasopressor support
- is less than 18 years of age
- is actively pregnant
- has an allergy to either of the drugs being studied (phenobarbital or lorazepam)
- is already intubated at the time of randomization
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
Sara J Riggenbach, BS, 309-624-5419, sara.j.riggenbach@osfhealthcare.org
Kimberly L Hartwig, BSN, (309) 655-4229, kimberly.hartwig@osfhealthcare.org
About this study
Official title: Phenobarbital Versus Ativan for Refractory Alcohol Withdrawal Treatment in the Intensive Care Unit
Our aim is to compare outcomes of patients with benzodiazepine-refractory alcohol withdrawal syndrome who are treated with either a phenobarbital-based or a lorazepam based protocol.
Read the detailed description
- This study is a prospective, open-label, randomized, controlled trial.
- The electronic medical record will be used to identify patients who have a diagnosis of alcohol withdrawal or are receiving alcohol withdrawal. Subjects who are anticipated to meet inclusion criteria will be pre-consented for the study using an informed consent process. see informed consent form.
- Subjects will not be enrolled and randomized until they have met inclusion criteria.
- If a patient meets criteria, but is deemed non-decisional or unable to give consent, the patient's medical decision maker will undergo the informed consent process.
- After enrollment, participants will be randomized to either the control group (lorazepam-based therapy) or the study group (phenobarbital-based therapy)
- Personnel unassociated with patient screening, enrollment, or follow up will create the allocation sequence and will use a random, computerized number generator. The allocation sequence will then be transferred to sequentially numbered, opaque envelopes for purposes of allocation concealment. These sequentially numbered envelopes, which are blinded to clinical trial coordinators/physicians, will be handed out in order as patients are enrolled. Clinical trial coordinators/physicians will verify treatment eligibility and informed consent before opening the envelope to obtain the treatment assignment.
- The study group will be placed on the phenobarbital-based protocol as described below in procedures. The control group will be placed on the lorazepam-based protocol, also listed below in procedures.
- All medications in the study are FDA approved. No investigational medicines will be used.
- Data will be collected on each participant as noted below in measurements.
- The data will be analyzed and published as noted above in the statistical analysis plan and data use and management section.
- Conditions
- Alcohol Withdrawal, Alcohol Withdrawal Delirium
- Being tested
- Phenobarbital, Lorazepam
- Keywords
- lorazepam, phenobarbital, ativan, alcohol withdrawal syndrome, alcohol withdrawal, intensive care unit, delirium tremens, refractory alcohol withdrawal, benzodiazepine
- Medical subject headings
- Alcohol Withdrawal Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenobarbitalDrug
Also called solfoton, luminal
Phenobarbital loading dose followed by a taper will be given to control acute alcohol withdrawal syndrome
LorazepamDrug
Also called ativan
Ativan will be given according to our institutional alcohol withdrawal protocol to control acute alcohol withdrawal syndrome
| Study group | Role | What they receive |
|---|---|---|
| Phenobarbital based treatment | Active comparator | * The phenobarbital group will undergo management with a phenobarbital based treatment protocol with additional symptom triggered therapies.
* On day 1, the phenobarbital group receive a loading dose of phenobarbital intravenous 10mg/kg (actual body weight) with a maximum dose of 1 g/100 mL
* On day 2 of study protocol, and no sooner than 12 hours after loading dose, phenobarbital 64.8 mg is administered every 12 hours for two doses.
* On day 3 of study protocol, patients will receive phenobarbital 32.4 mg every 12 hours for two doses.
* On day 4 of study protocol, patients will receive phenobarbital 32.4 mg once, to be given 24 hours after last scheduled dose.
* Throughout the 4 day protocol, the patient will have phenobarbital 65 mg every 6 hours as needed available either IM or IV, starting no sooner than 30 minutes after the loading dose. Receives: Drug: Phenobarbital |
| Lorazepam based treatment | Active comparator | * The lorazepam group will undergo management with a lorazepam based treatment protocol with additional symptom triggered therapies.
* On Day 1, the lorazepam group will be started on scheduled lorazepam 4 mg every 6 hours
* After day 1, the scheduled lorazepam dose will be modified based on the total lorazepam requirements from the previous day and divided into 4-6 doses.
* A lorazepam infusion, at physician discretion, will be available at any point if the dose of scheduled and PRN lorazepam being given is too high or frequent to effectively be administered.
* Once symptoms are well controlled on lorazepam based therapy, the total dose given over the past 24 hours will be calculated and weaned by approximately 10-20% per day when clinically appropriate.
* Throughout the entire protocol, 2-4 mg lorazepam IV q 30 minutes PRN will be available for a goal CIWA <6 or RASS -1 to 0. Receives: Drug: Lorazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU length of stay
number of days in the intensive care unit
Measured: study completion, up to 18 months
Secondary outcomes (8)
Hospital length of stay
number of days in the hospital
Measured: Study completion, up to 18 months
30-day readmission
rate of readmission of patients within 30 days for any cause
Measured: study complettion, up to 18 months
mortality
number of deaths
Measured: Study completion, up to 18 months
Intubation
rate of endotracheal intubation
Measured: study completion, up to 18 months
Hospitalization cost
Cost of index hospital stay
Measured: Study completion, up to 18 months
Lorazepam use
total lorazepam use in mg during the entire hospital stay
Measured: Study completion, up to 18 months
dexmedetomidine use
total dexmedetomidine used in mcg during the entire hospital stay
Measured: Study completion, up to 18 months
propofol use
total propofol used in mg during the entire hospital stay
Measured: Study completion, up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start6 Jul 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Alcohol WithdrawalStudies 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
- 2 arms
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OSF Healthcare System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bhagat Aulakh, OSF Healthcare System
- Investigators
- Bhagat Aulakh, MD, Principal investigator, OSF Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156464
- Sponsor's protocol ID
- 1499413
- Acronym
- PARTI
- Status last verified
- Oct 2020
- First submitted
- 16 Oct 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Friedmann PD. Alcohol use in adults. N Engl J Med. 2013 Apr 25;368(17):1655-6. doi: 10.1056/NEJMc1302445. No abstract available.
PubMed 23614598Saitz R, Friedman LS, Mayo-Smith MF. Alcohol withdrawal: a nationwide survey of inpatient treatment practices. J Gen Intern Med. 1995 Sep;10(9):479-87. doi: 10.1007/BF02602395.
PubMed 8523149Kosten TR, O'Connor PG. Management of drug and alcohol withdrawal. N Engl J Med. 2003 May 1;348(18):1786-95. doi: 10.1056/NEJMra020617. No abstract available.
PubMed 12724485Holbrook AM, Crowther R, Lotter A, Cheng C, King D. Diagnosis and management of acute alcohol withdrawal. CMAJ. 1999 Mar 9;160(5):675-80.
PubMed 10102003Miller NS, Gold MS. Management of withdrawal syndromes and relapse prevention in drug and alcohol dependence. Am Fam Physician. 1998 Jul;58(1):139-46.
PubMed 9672434Kaim SC, Klett CJ, Rothfeld B. Treatment of the acute alcohol withdrawal state: a comparison of four drugs. Am J Psychiatry. 1969 Jun;125(12):1640-6. doi: 10.1176/ajp.125.12.1640. No abstract available.
PubMed 4890289Sarff M, Gold JA. Alcohol withdrawal syndromes in the intensive care unit. Crit Care Med. 2010 Sep;38(9 Suppl):S494-501. doi: 10.1097/CCM.0b013e3181ec5412.
PubMed 20724883Dixit D, Endicott J, Burry L, Ramos L, Yeung SY, Devabhakthuni S, Chan C, Tobia A, Bulloch MN. Management of Acute Alcohol Withdrawal Syndrome in Critically Ill Patients. Pharmacotherapy. 2016 Jul;36(7):797-822. doi: 10.1002/phar.1770. Epub 2016 Jun 30.
PubMed 27196747Hack JB, Hoffmann RS, Nelson LS. Resistant alcohol withdrawal: does an unexpectedly large sedative requirement identify these patients early? J Med Toxicol. 2006 Jun;2(2):55-60. doi: 10.1007/BF03161171.
PubMed 18072114Wong A, Benedict NJ, Lohr BR, Pizon AF, Kane-Gill SL. Management of benzodiazepine-resistant alcohol withdrawal across a healthcare system: Benzodiazepine dose-escalation with or without propofol. Drug Alcohol Depend. 2015 Sep 1;154:296-9. doi: 10.1016/j.drugalcdep.2015.07.005. Epub 2015 Jul 16.
PubMed 26205315Duby JJ, Berry AJ, Ghayyem P, Wilson MD, Cocanour CS. Alcohol withdrawal syndrome in critically ill patients: protocolized versus nonprotocolized management. J Trauma Acute Care Surg. 2014 Dec;77(6):938-43. doi: 10.1097/TA.0000000000000352.
PubMed 25248063Crispo AL, Daley MJ, Pepin JL, Harford PH, Brown CV. Comparison of clinical outcomes in nonintubated patients with severe alcohol withdrawal syndrome treated with continuous-infusion sedatives: dexmedetomidine versus benzodiazepines. Pharmacotherapy. 2014 Sep;34(9):910-7. doi: 10.1002/phar.1448. Epub 2014 Jun 5.
PubMed 24898418Pandharipande PP, Pun BT, Herr DL, Maze M, Girard TD, Miller RR, Shintani AK, Thompson JL, Jackson JC, Deppen SA, Stiles RA, Dittus RS, Bernard GR, Ely EW. Effect of sedation with dexmedetomidine vs lorazepam on acute brain dysfunction in mechanically ventilated patients: the MENDS randomized controlled trial. JAMA. 2007 Dec 12;298(22):2644-53. doi: 10.1001/jama.298.22.2644.
PubMed 18073360Ives TJ, Mooney AJ 3rd, Gwyther RE. Pharmacokinetic dosing of phenobarbital in the treatment of alcohol withdrawal syndrome. South Med J. 1991 Jan;84(1):18-21. doi: 10.1097/00007611-199101000-00006.
PubMed 1986421Tangmose K, Nielsen MK, Allerup P, Ulrichsen J. Linear correlation between phenobarbital dose and concentration in alcohol withdrawal patients. Dan Med Bull. 2010 Aug;57(8):A4141.
PubMed 20682131
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenobarbital Versus Ativan for Refractory Alcohol Withdrawal Treatment in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04156464
- Acronym / sponsor ID
- PARTI / 1499413
- Conditions
- Alcohol Withdrawal, Alcohol Withdrawal Delirium
- Keywords
- lorazepam, phenobarbital, ativan, alcohol withdrawal syndrome, alcohol withdrawal, intensive care unit, delirium tremens, refractory alcohol withdrawal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- OSF Healthcare SystemUniversity, hospital or other
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 7 Nov 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.
Our aim is to compare outcomes of patients with benzodiazepine-refractory alcohol withdrawal syndrome who are treated with either a phenobarbital-based or a lorazepam based protocol.
Detailed description
- This study is a prospective, open-label, randomized, controlled trial.
- The electronic medical record will be used to identify patients who have a diagnosis of alcohol withdrawal or are receiving alcohol withdrawal. Subjects who are anticipated to meet inclusion criteria will be pre-consented for the study using an informed consent process. see informed consent form.
- Subjects will not be enrolled and randomized until they have met inclusion criteria.
- If a patient meets criteria, but is deemed non-decisional or unable to give consent, the patient's medical decision maker will undergo the informed consent process.
- After enrollment, participants will be randomized to either the control group (lorazepam-based therapy) or the study group (phenobarbital-based therapy)
- Personnel unassociated with patient screening, enrollment, or follow up will create the allocation sequence and will use a random, computerized number generator. The allocation sequence will then be transferred to sequentially numbered, opaque envelopes for purposes of allocation concealment. These sequentially numbered envelopes, which are blinded to clinical trial coordinators/physicians, will be handed out in order as patients are enrolled. Clinical trial coordinators/physicians will verify treatment eligibility and informed consent before opening the envelope to obtain the treatment assignment.
- The study group will be placed on the phenobarbital-based protocol as described below in procedures. The control group will be placed on the lorazepam-based protocol, also listed below in procedures.
- All medications in the study are FDA approved. No investigational medicines will be used.
- Data will be collected on each participant as noted below in measurements.
- The data will be analyzed and published as noted above in the statistical analysis plan and data use and management section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 arms
| Arm | Type | Receives |
|---|---|---|
| Phenobarbital based treatment | Active comparator | Drug: Phenobarbital* The phenobarbital group will undergo management with a phenobarbital based treatment protocol with additional symptom triggered therapies. * On day 1, the phenobarbital group receive a loading dose of phenobarbital intravenous 10mg/kg (actual body weight) with a maximum dose of 1 g/100 mL * On day 2 of study protocol, and no sooner than 12 hours after loading dose, phenobarbital 64.8 mg is administered every 12 hours for two doses. * On day 3 of study protocol, patients will receive phenobarbital 32.4 mg every 12 hours for two doses. * On day 4 of study protocol, patients will receive phenobarbital 32.4 mg once, to be given 24 hours after last scheduled dose. * Throughout the 4 day protocol, the patient will have phenobarbital 65 mg every 6 hours as needed available either IM or IV, starting no sooner than 30 minutes after the loading dose. |
| Lorazepam based treatment | Active comparator | Drug: Lorazepam* The lorazepam group will undergo management with a lorazepam based treatment protocol with additional symptom triggered therapies. * On Day 1, the lorazepam group will be started on scheduled lorazepam 4 mg every 6 hours * After day 1, the scheduled lorazepam dose will be modified based on the total lorazepam requirements from the previous day and divided into 4-6 doses. * A lorazepam infusion, at physician discretion, will be available at any point if the dose of scheduled and PRN lorazepam being given is too high or frequent to effectively be administered. * Once symptoms are well controlled on lorazepam based therapy, the total dose given over the past 24 hours will be calculated and weaned by approximately 10-20% per day when clinically appropriate. * Throughout the entire protocol, 2-4 mg lorazepam IV q 30 minutes PRN will be available for a goal CIWA <6 or RASS -1 to 0. |
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 will be eligible for randomization if he/she has met one of the following three conditions:
Key exclusion criteria (7 listed)
- Patients will be excluded from the study if he/she:
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 |
|---|---|---|
| PhenobarbitalAlso: solfoton, luminalPhenobarbital loading dose followed by a taper will be given to control acute alcohol withdrawal syndrome | Drug | Phenobarbital based treatment |
| LorazepamAlso: ativanAtivan will be given according to our institutional alcohol withdrawal protocol to control acute alcohol withdrawal syndrome | Drug | Lorazepam based treatment |
Primary outcome
ICU length of stay
Time frame: study completion, up to 18 months
number of days in the intensive care unit
8 secondary outcomes
Hospital length of stay
Time frame: Study completion, up to 18 months
30-day readmission
Time frame: study complettion, up to 18 months
mortality
Time frame: Study completion, up to 18 months
Intubation
Time frame: study completion, up to 18 months
Hospitalization cost
Time frame: Study completion, up to 18 months
Lorazepam use
Time frame: Study completion, up to 18 months
dexmedetomidine use
Time frame: Study completion, up to 18 months
propofol use
Time frame: Study completion, up to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Background: PubMed 23614598Friedmann PD. Alcohol use in adults. N Engl J Med. 2013 Apr 25;368(17):1655-6. doi: 10.1056/NEJMc1302445. No abstract available.
- Background: PubMed 8523149Saitz R, Friedman LS, Mayo-Smith MF. Alcohol withdrawal: a nationwide survey of inpatient treatment practices. J Gen Intern Med. 1995 Sep;10(9):479-87. doi: 10.1007/BF02602395.
- Background: PubMed 12724485Kosten TR, O'Connor PG. Management of drug and alcohol withdrawal. N Engl J Med. 2003 May 1;348(18):1786-95. doi: 10.1056/NEJMra020617. No abstract available.
- Background: PubMed 10102003Holbrook AM, Crowther R, Lotter A, Cheng C, King D. Diagnosis and management of acute alcohol withdrawal. CMAJ. 1999 Mar 9;160(5):675-80.
- Background: PubMed 9672434Miller NS, Gold MS. Management of withdrawal syndromes and relapse prevention in drug and alcohol dependence. Am Fam Physician. 1998 Jul;58(1):139-46.
- Background: PubMed 4890289Kaim SC, Klett CJ, Rothfeld B. Treatment of the acute alcohol withdrawal state: a comparison of four drugs. Am J Psychiatry. 1969 Jun;125(12):1640-6. doi: 10.1176/ajp.125.12.1640. No abstract available.
- Background: PubMed 20724883Sarff M, Gold JA. Alcohol withdrawal syndromes in the intensive care unit. Crit Care Med. 2010 Sep;38(9 Suppl):S494-501. doi: 10.1097/CCM.0b013e3181ec5412.
- Background: PubMed 27196747Dixit D, Endicott J, Burry L, Ramos L, Yeung SY, Devabhakthuni S, Chan C, Tobia A, Bulloch MN. Management of Acute Alcohol Withdrawal Syndrome in Critically Ill Patients. Pharmacotherapy. 2016 Jul;36(7):797-822. doi: 10.1002/phar.1770. Epub 2016 Jun 30.
- Background: PubMed 18072114Hack JB, Hoffmann RS, Nelson LS. Resistant alcohol withdrawal: does an unexpectedly large sedative requirement identify these patients early? J Med Toxicol. 2006 Jun;2(2):55-60. doi: 10.1007/BF03161171.
- Background: PubMed 26205315Wong A, Benedict NJ, Lohr BR, Pizon AF, Kane-Gill SL. Management of benzodiazepine-resistant alcohol withdrawal across a healthcare system: Benzodiazepine dose-escalation with or without propofol. Drug Alcohol Depend. 2015 Sep 1;154:296-9. doi: 10.1016/j.drugalcdep.2015.07.005. Epub 2015 Jul 16.
- Background: PubMed 25248063Duby JJ, Berry AJ, Ghayyem P, Wilson MD, Cocanour CS. Alcohol withdrawal syndrome in critically ill patients: protocolized versus nonprotocolized management. J Trauma Acute Care Surg. 2014 Dec;77(6):938-43. doi: 10.1097/TA.0000000000000352.
- Background: PubMed 24898418Crispo AL, Daley MJ, Pepin JL, Harford PH, Brown CV. Comparison of clinical outcomes in nonintubated patients with severe alcohol withdrawal syndrome treated with continuous-infusion sedatives: dexmedetomidine versus benzodiazepines. Pharmacotherapy. 2014 Sep;34(9):910-7. doi: 10.1002/phar.1448. Epub 2014 Jun 5.
- Individual participant dataSharing planned: No
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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.
Bhagat Aulakh, MD principal investigator
OSF Healthcare System
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 Phenobarbital and Lorazepam in people with Alcohol Withdrawal and Alcohol Withdrawal Delirium, run by OSF Healthcare System at 1 site in United States.
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: status not confirmed, as of the sponsor's last update on 8 Oct 2020. 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 United States. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachael M Davis, MD (309-655-7257, rachael.m.davis@osfhealthcare.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU length of stay (time frame: study completion, up to 18 months). 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 NCT04156464, which also lists 28 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 8 Oct 2020.