DeliriumNCT01700816
Prevention of Delirium After Bone Marrow Transplantation
A study testing Bright light therapy in people with Delirium, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to find out if using bright light sessions during bone marrow transplant can prevent people from developing confusion also known as delirium. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Delirium
- What is being tested?
- Bright light therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Oct 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 or older
- Male or female
- Patients scheduled to undergo HSCT
- English speaking
Who cannot join
- Previous history of bipolar affective disorder
- On-going delirium
- History of substance abuse/dependence within 6 months prior to HSCT
- History of invasive melanoma. Patients with a history of basal cell carcinoma, melanoma in situ, or squamous cell carcinoma are permitted to enroll if the lesion(s) have been excised with negative margins
- History of medical/dermatological conditions that make skin especially sensitive to light,such as systemic lupus erythematosus (SLE) and/or porphyria
- Eye condition that makes eyes vulnerable to light damage
- Concomitant use of medications that increase sensitivity to sunlight, such as the herbal supplement St. John's Wort
- Established primary insomnia
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Usefulness of Bright Light Therapy in the Prevention of Delirium in Patients Undergoing Hematopoietic Stem Cell Transplant (HSCT)
The purpose of this study is to find out if using bright light sessions during bone marrow transplant can prevent people from developing confusion also known as delirium.
Read the detailed description
This is a pilot, double blind randomized study conducted in patients scheduled to undergo bone marrow transplant at the Massachusetts General Hospital. The goal of this study is to look at the usefulness of bright light therapy in the prevention of delirium in a population at high risk for developing this condition.
Delirium can develop in up to half of the people that undergo bone marrow transplant. Symptoms include changes in level of alertness, confusion, and temporary problems with memory and attention. In severe cases, it can be accompanied by agitation, paranoia(overly suspicious), and hallucinations(seeing or hearing things that are not really there).
Bright light uses no medication and is often used to treat seasonal affective depression and multiple sleep disorders. The light boxes are portable and are placed in front of individuals for about 30 minutes every day.
- Conditions
- Delirium
- Being tested
- Bright light therapy, Sham light
- Keywords
- Delirium, Hematopoietic stem cell transplantation, Bone marrow transplantation, Bright Light Therapy
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright light therapyDevice
Also called DL930 Day-Light Classic by Uplift Technologies Inc.
The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.
Sham lightDevice
Also called DL930 Day-Light Classic Uplift Tecnologies placebo box
The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.
| Study group | Role | What they receive |
|---|---|---|
| Bright light therapy | Experimental | 2500 Lux gaze directed every morning from 8 am until 8:30 am Receives: Device: Bright light therapy |
| Sham light | Placebo comparator | <1000 Lux gaze directed every morning from 8 am until 8:30 am Receives: Device: Sham light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Developed Delirium Based on Meeting Criteria on the Delirium Rating Scale and/or Memorial Delirium Assessment Scale
Monday, Wednesday, and Friday assessments will begin after beginning light therapy and include the Delirium Rating Scale-Revised-98 (DRS-98)and Memorial Delirium Assessment Scale (MDAS)
Measured: From hospital admission until the date of first documented delirium, assessed up to 28 days post-transplant
Secondary outcomes (10)
Severity of Delirium Episodes: Memorial Delirium Assessment Scale (MDAS)
Monday, Wednesday, and Friday assessments of the Memorial Delirium Assessment Scale (MDAS); Patients will receive assessments after beginning light therapy until day 28 post-transplant or discharge, whichever comes first.
10 item scale Items are rated on a four-point scale from 0 (none) to 3 (severe) depending on the level of impairment, rendering a maximum possible score of 30.
A score of 13 has been recommended as a cut-off for establishing the diagnosis of delirium
Measured: From first documented episode of delirium until discharge from the hospital, assessed up to 28 days post-transplant
Average Dose of Antipsychotic Medications Required to Manage Delirium
Measured: From admission to hospital to discharge, an expected average of 28 days post-transplant
Hospital Length of Stay
Measured: From admission to hospital to discharge, an expected average of 28 days post-transplant
Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2)
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT (Hematopoietic Stem Cell Transplantation).
Measured: From admission to hospital to discharge, an expected average of 28 days post-transplant
Serum Creatinine and Blood Urea Nitrogen (BUN)
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
Measured: From admission to hospital to discharge, an expected average of 28 days post-transplant
Red Blood Cells (RBC)
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
Measured: From admission to hospital to discharge, an expected average of 28 days post-transplant
White Blood Cells (WBC)
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
Measured: From admission to hospital to discharge, an expected average of 28 days post-transplant
Hemoglobin (HGB)
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
Measured: From admission to hospital to discharge, an expected average of 28 days post-transplant
Hematocrit (HCT)
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
Measured: From admission to hospital to discharge, an expected average of 28 days post-transplant
Platelet Count
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
Measured: From admission to hospital to discharge, an expected average of 28 days post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2013
- Study completionOct 2013
Why it stopped: Low incidence of delirium.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Carlos Fernandez-Robles, Massachusetts General Hospital
- Investigators
- Carlos Fernandez-Robles, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700816
- Sponsor's protocol ID
- 2010P002801
- Status last verified
- May 2017
- First submitted
- 1 Oct 2012
- Last updated
- 28 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kirshner HS. Delirium: a focused review. Curr Neurol Neurosci Rep. 2007 Nov;7(6):479-82. doi: 10.1007/s11910-007-0074-7.
PubMed 17999893Minden SL, Carbone LA, Barsky A, Borus JF, Fife A, Fricchione GL, Orav EJ. Predictors and outcomes of delirium. Gen Hosp Psychiatry. 2005 May-Jun;27(3):209-14. doi: 10.1016/j.genhosppsych.2004.12.004.
PubMed 15882768Inouye SK, Schlesinger MJ, Lydon TJ. Delirium: a symptom of how hospital care is failing older persons and a window to improve quality of hospital care. Am J Med. 1999 May;106(5):565-73. doi: 10.1016/s0002-9343(99)00070-4.
PubMed 10335730Fricchione GL, Nejad SH, Esses JA, Cummings TJ Jr, Querques J, Cassem NH, Murray GB. Postoperative delirium. Am J Psychiatry. 2008 Jul;165(7):803-12. doi: 10.1176/appi.ajp.2008.08020181. No abstract available.
PubMed 18593786Hshieh TT, Fong TG, Marcantonio ER, Inouye SK. Cholinergic deficiency hypothesis in delirium: a synthesis of current evidence. J Gerontol A Biol Sci Med Sci. 2008 Jul;63(7):764-72. doi: 10.1093/gerona/63.7.764.
PubMed 18693233Kalisvaart KJ, de Jonghe JF, Bogaards MJ, Vreeswijk R, Egberts TC, Burger BJ, Eikelenboom P, van Gool WA. Haloperidol prophylaxis for elderly hip-surgery patients at risk for delirium: a randomized placebo-controlled study. J Am Geriatr Soc. 2005 Oct;53(10):1658-66. doi: 10.1111/j.1532-5415.2005.53503.x.
PubMed 16181163Prakanrattana U, Prapaitrakool S. Efficacy of risperidone for prevention of postoperative delirium in cardiac surgery. Anaesth Intensive Care. 2007 Oct;35(5):714-9. doi: 10.1177/0310057X0703500509.
PubMed 17933157Liptzin B, Laki A, Garb JL, Fingeroth R, Krushell R. Donepezil in the prevention and treatment of post-surgical delirium. Am J Geriatr Psychiatry. 2005 Dec;13(12):1100-6. doi: 10.1176/appi.ajgp.13.12.1100.
PubMed 16319303Sampson EL, Raven PR, Ndhlovu PN, Vallance A, Garlick N, Watts J, Blanchard MR, Bruce A, Blizard R, Ritchie CW. A randomized, double-blind, placebo-controlled trial of donepezil hydrochloride (Aricept) for reducing the incidence of postoperative delirium after elective total hip replacement. Int J Geriatr Psychiatry. 2007 Apr;22(4):343-9. doi: 10.1002/gps.1679.
PubMed 17006875Leung JM, Sands LP, Rico M, Petersen KL, Rowbotham MC, Dahl JB, Ames C, Chou D, Weinstein P. Pilot clinical trial of gabapentin to decrease postoperative delirium in older patients. Neurology. 2006 Oct 10;67(7):1251-3. doi: 10.1212/01.wnl.0000233831.87781.a9. Epub 2006 Aug 16.
PubMed 16914695Tabet N, Howard R. Non-pharmacological interventions in the prevention of delirium. Age Ageing. 2009 Jul;38(4):374-9. doi: 10.1093/ageing/afp039. Epub 2009 May 21.
PubMed 19460856Inouye SK, Bogardus ST Jr, Charpentier PA, Leo-Summers L, Acampora D, Holford TR, Cooney LM Jr. A multicomponent intervention to prevent delirium in hospitalized older patients. N Engl J Med. 1999 Mar 4;340(9):669-76. doi: 10.1056/NEJM199903043400901.
PubMed 10053175Lipowski ZJ. Delirium (acute confusional states). JAMA. 1987 Oct 2;258(13):1789-92.
PubMed 3625989Shigeta H, Yasui A, Nimura Y, Machida N, Kageyama M, Miura M, Menjo M, Ikeda K. Postoperative delirium and melatonin levels in elderly patients. Am J Surg. 2001 Nov;182(5):449-54. doi: 10.1016/s0002-9610(01)00761-9.
PubMed 11754849McIntyre IM, Norman TR, Burrows GD, Armstrong SM. Human melatonin suppression by light is intensity dependent. J Pineal Res. 1989;6(2):149-56. doi: 10.1111/j.1600-079x.1989.tb00412.x.
PubMed 2915324
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Bright Light Therapy in the Prevention of Delirium in Patients Undergoing Hematopoietic Stem Cell Transplant (HSCT)
- ClinicalTrials.gov ID
- NCT01700816
- Acronym / sponsor ID
- 2010P002801
- Conditions
- Delirium
- Keywords
- Delirium, Hematopoietic stem cell transplantation, Bone marrow transplantation, Bright Light Therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low incidence of delirium.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Oct 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 4 Oct 2012 (estimated)
- Results
- Posted 28 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out if using bright light sessions during bone marrow transplant can prevent people from developing confusion also known as delirium.
Detailed description
This is a pilot, double blind randomized study conducted in patients scheduled to undergo bone marrow transplant at the Massachusetts General Hospital. The goal of this study is to look at the usefulness of bright light therapy in the prevention of delirium in a population at high risk for developing this condition.
Delirium can develop in up to half of the people that undergo bone marrow transplant. Symptoms include changes in level of alertness, confusion, and temporary problems with memory and attention. In severe cases, it can be accompanied by agitation, paranoia(overly suspicious), and hallucinations(seeing or hearing things that are not really there).
Bright light uses no medication and is often used to treat seasonal affective depression and multiple sleep disorders. The light boxes are portable and are placed in front of individuals for about 30 minutes every day.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bright light therapy | Experimental | Device: Bright light therapy2500 Lux gaze directed every morning from 8 am until 8:30 am |
| Sham light | Placebo comparator | Device: Sham light<1000 Lux gaze directed every morning from 8 am until 8:30 am |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 or older
- Male or female
- Patients scheduled to undergo HSCT
- English speaking
Key exclusion criteria (8 listed)
- Previous history of bipolar affective disorder
- On-going delirium
- History of substance abuse/dependence within 6 months prior to HSCT
- History of invasive melanoma. Patients with a history of basal cell carcinoma, melanoma in situ, or squamous cell carcinoma are permitted to enroll if the lesion(s) have been excised with negative margins
- History of medical/dermatological conditions that make skin especially sensitive to light,such as systemic lupus erythematosus (SLE) and/or porphyria
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 |
|---|---|---|
| Bright light therapyAlso: DL930 Day-Light Classic by Uplift Technologies Inc.The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am. | Device | Bright light therapy |
| Sham lightAlso: DL930 Day-Light Classic Uplift Tecnologies placebo boxThe light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am. | Device | Sham light |
Primary outcome
Number of Participants Who Developed Delirium Based on Meeting Criteria on the Delirium Rating Scale and/or Memorial Delirium Assessment Scale
Time frame: From hospital admission until the date of first documented delirium, assessed up to 28 days post-transplant
Monday, Wednesday, and Friday assessments will begin after beginning light therapy and include the Delirium Rating Scale-Revised-98 (DRS-98)and Memorial Delirium Assessment Scale (MDAS)
10 secondary outcomes
Severity of Delirium Episodes: Memorial Delirium Assessment Scale (MDAS)
Time frame: From first documented episode of delirium until discharge from the hospital, assessed up to 28 days post-transplant
Average Dose of Antipsychotic Medications Required to Manage Delirium
Time frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
Hospital Length of Stay
Time frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2)
Time frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
Serum Creatinine and Blood Urea Nitrogen (BUN)
Time frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
Red Blood Cells (RBC)
Time frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
White Blood Cells (WBC)
Time frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
Hemoglobin (HGB)
Time frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
Hematocrit (HCT)
Time frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
Platelet Count
Time frame: From admission to hospital to discharge, an expected average of 28 days post-transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17999893Kirshner HS. Delirium: a focused review. Curr Neurol Neurosci Rep. 2007 Nov;7(6):479-82. doi: 10.1007/s11910-007-0074-7.
- Background: PubMed 15882768Minden SL, Carbone LA, Barsky A, Borus JF, Fife A, Fricchione GL, Orav EJ. Predictors and outcomes of delirium. Gen Hosp Psychiatry. 2005 May-Jun;27(3):209-14. doi: 10.1016/j.genhosppsych.2004.12.004.
- Background: PubMed 10335730Inouye SK, Schlesinger MJ, Lydon TJ. Delirium: a symptom of how hospital care is failing older persons and a window to improve quality of hospital care. Am J Med. 1999 May;106(5):565-73. doi: 10.1016/s0002-9343(99)00070-4.
- Background: PubMed 18593786Fricchione GL, Nejad SH, Esses JA, Cummings TJ Jr, Querques J, Cassem NH, Murray GB. Postoperative delirium. Am J Psychiatry. 2008 Jul;165(7):803-12. doi: 10.1176/appi.ajp.2008.08020181. No abstract available.
- Background: PubMed 18693233Hshieh TT, Fong TG, Marcantonio ER, Inouye SK. Cholinergic deficiency hypothesis in delirium: a synthesis of current evidence. J Gerontol A Biol Sci Med Sci. 2008 Jul;63(7):764-72. doi: 10.1093/gerona/63.7.764.
- Background: PubMed 16181163Kalisvaart KJ, de Jonghe JF, Bogaards MJ, Vreeswijk R, Egberts TC, Burger BJ, Eikelenboom P, van Gool WA. Haloperidol prophylaxis for elderly hip-surgery patients at risk for delirium: a randomized placebo-controlled study. J Am Geriatr Soc. 2005 Oct;53(10):1658-66. doi: 10.1111/j.1532-5415.2005.53503.x.
- Background: PubMed 17933157Prakanrattana U, Prapaitrakool S. Efficacy of risperidone for prevention of postoperative delirium in cardiac surgery. Anaesth Intensive Care. 2007 Oct;35(5):714-9. doi: 10.1177/0310057X0703500509.
- Background: PubMed 16319303Liptzin B, Laki A, Garb JL, Fingeroth R, Krushell R. Donepezil in the prevention and treatment of post-surgical delirium. Am J Geriatr Psychiatry. 2005 Dec;13(12):1100-6. doi: 10.1176/appi.ajgp.13.12.1100.
- Background: PubMed 17006875Sampson EL, Raven PR, Ndhlovu PN, Vallance A, Garlick N, Watts J, Blanchard MR, Bruce A, Blizard R, Ritchie CW. A randomized, double-blind, placebo-controlled trial of donepezil hydrochloride (Aricept) for reducing the incidence of postoperative delirium after elective total hip replacement. Int J Geriatr Psychiatry. 2007 Apr;22(4):343-9. doi: 10.1002/gps.1679.
- Background: PubMed 16914695Leung JM, Sands LP, Rico M, Petersen KL, Rowbotham MC, Dahl JB, Ames C, Chou D, Weinstein P. Pilot clinical trial of gabapentin to decrease postoperative delirium in older patients. Neurology. 2006 Oct 10;67(7):1251-3. doi: 10.1212/01.wnl.0000233831.87781.a9. Epub 2006 Aug 16.
- Background: PubMed 19460856Tabet N, Howard R. Non-pharmacological interventions in the prevention of delirium. Age Ageing. 2009 Jul;38(4):374-9. doi: 10.1093/ageing/afp039. Epub 2009 May 21.
- Background: PubMed 10053175Inouye SK, Bogardus ST Jr, Charpentier PA, Leo-Summers L, Acampora D, Holford TR, Cooney LM Jr. A multicomponent intervention to prevent delirium in hospitalized older patients. N Engl J Med. 1999 Mar 4;340(9):669-76. doi: 10.1056/NEJM199903043400901.
- Individual participant dataSharing planned: No
Related trials for Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
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.
Carlos Fernandez-Robles, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright light therapy in people with Delirium, run by Massachusetts General Hospital 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 8 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: stopped early, as of the sponsor's last update on 28 Jun 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 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. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Developed Delirium Based on Meeting Criteria on the Delirium Rating Scale and/or Memorial Delirium Assessment Scale (time frame: From hospital admission until the date of first documented delirium, assessed up to 28 days post-transplant). 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 NCT01700816, which also lists 27 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 28 Jun 2017.