DeliriumPhase 4NCT00303433
Namenda to Prevent Post-Operative Delirium
A Phase 4 study testing Namenda in people with Delirium and Post-Operative States, run by University of Rochester at 1 site in United States.
Trial summary
Post Operative Delirium is a common and serious risk of surgery. Delirium, when it occurs is associated with an increased risk of mortality, increase length of stay, and more adverse outcomes in general, including increased risk of higher level of care required at discharge. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Delirium, Post-Operative States
- What is being tested?
- Namenda
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Sep 2006
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medically stable
- 50 years of age or older
- having elective joint replacement surgery or other orthopedic procedures that are major surgery and require general anesthesia.
Who cannot join
- Alcohol or sedative hypnotic abuse or dependence
- Pregnancy
- Dementia or MR/DD patients if they do not have sufficient capacity to understand the consent
- renal impairment or a creatinine of 1.4 or higher
- currently taking cholinesterase inhibitors.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Namenda as Prevention for Post-Operative Delirium
Post Operative Delirium is a common and serious risk of surgery. Delirium, when it occurs is associated with an increased risk of mortality, increase length of stay, and more adverse outcomes in general, including increased risk of higher level of care required at discharge.
Namenda, which is currently approved for moderate or severe Alzheimer's disease has a unique mechanism of action than other drugs for this condition. It may have the ability to protect the brain from more severe consequences of hypoxia, or hypoglycemia. Hence it is being looked at in this study to see if it can reduce the incidence and/or severity of delirium post-operatively.
Read the detailed description
Objectives of this double blind placebo-controlled study are to determine the efficacy, safety and tolerability of Namenda in the prevention of post-operative delirium as defined by DSM-IV-TR categories 293.0 Delirium due to medical condition or medications, and 780.09 Delirium NOS. The incidence of post-operative delirium is 10-50% of general surgical cases, depending on the population studied. Delirium is known to affect mortality and morbidity, and increase the length of stay of patients. Hospital mortality estimates in patients with delirium range from 10-65%, estimated to be 2-20 times that of control patients without delirium. Delirium is an independent prognostic determinant of hospital outcomes, including death, new nursing home placements and functional decline. Delirium is an independent marker for increased mortality among older medical inpatients in the 12 months post hospitalization, particularly in those patients without dementia.
Delirium may be better understood by a Multifactorial Model of Delirium, which involves a complex inter-relationship between predisposing Factors/Vulnerability and Precipitating Factors/Insults.
If higher risk factors can be identified, then preventive interventions targeted to these groups may be able to significantly reduce morbitity, possibly mortality, but at minimum improve the quality of life of those patients who otherwise would have gone through such an enormously traumatic and disturbing experience as the psychosis and disorientation of a delirium.
The Academy of Psyhosomatic Medicine Task Force on Mental Disorders in General Medical Practice, found that co-morbid delirium increased hospital length of stay: 100% in general medical inpatients, 114% in elderly patients, 67% in stroke patients, 300% in critical care patients, 27% in cardiac surgery patients, and 200-250% in hip surgery patients.
Overall Design and Plan of Study: 30 Surgical patients (type of elective surgery: total hip and total knee replacements) will be randomized into two arms of the study attempting to get a similar mean age for each group: Group 1: 15 patients receive placebo Day --8,--7,--6,--5,--4,--3,--2,--1,Day 0 (surgery), Post-op day 1,2,3, and 4. Group 2: 15 patients receive (10 mg) of Namenda (memantine) Day --8,--7,--6,--5,--4,--3,--2, then 20 mg per day on Day --1, day 0 (surgery), Post-op day 1,2,3 then 10 mg per day Post-op day 4, then stop Namenda.
Both groups will receive a MMSE, CLOX, Confusion Assessment Method (CAM) and the Delirium Rating Scale-Revised-98 Scale on day --8 (or before drug/placebo), day --1, then post-op day 1-6. Actigraphy will be performed day --8 through post-op day 6, and sleep diaries will be collected (subjected diaries pre-hospital day --8 through day --1, then objective diaries, day --1 through post-op day 6 in hospital).
Baseline screening blood tests will be drawn on all patients and include SMA-8 including BUN and creatinine, serum albumin, TSH, NH3 and baseline BP, Pulse and Temperature. Pre-op hematocrit has been shown to be a predictor as well, and may be worthwhile to follow up in these patients.
If delirium should develop in any patients, treatment will be as per usual standard of care, with likely psychiatric consultation and medications used will be tracked.
Pharmaco-economic arm (PEA) of syudy: We are working with hospital administration and will be able to obtain costs of care such as the following: room charges, locations (whether ICU, step-down unit or regular floor etc), pharmacy costs, cost of consultations needed, number of days in the hospital needed for each group. Discharge outcome (disposition, need for SNF vs. home, visiting nurse service needs) will be compared at discharge, and fo;;ow-up 30 days later.
- Conditions
- Delirium, Post-Operative States
- Being tested
- Namenda
- Keywords
- Prevention, Post-Operative tates, Delirium, Namenda
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NamendaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of delirium measured by Delirium Rating Scale-Revised-98, MMSE. Confusion Assessment Method, Clock Drawing Tests (CLOX), DSM-IV-TR criteria for Delirium.
Secondary outcomes (1)
Length and cost of stay, disposition, level of care required post hosptialization, hospitalization satisfaction, number of consultants involved, total costs of care.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2006 (estimated)
- Study startMar 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Investigators
- Michael R Privitera, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00303433
- Sponsor's protocol ID
- RSRB-00012460
- Other IDs
- NAM-MD-35
- Status last verified
- Dec 2009
- First submitted
- 14 Mar 2006
- Last updated
- 3 Jun 2015
- Results posted
- No
Publications
Schwartz TL, Masand PS. The role of atypical antipsychotics in the treatment of delirium. Psychosomatics. 2002 May-Jun;43(3):171-4. doi: 10.1176/appi.psy.43.3.171.
PubMed 12075031Breitbart W, Rosenfeld B, Roth A, Smith MJ, Cohen K, Passik S. The Memorial Delirium Assessment Scale. J Pain Symptom Manage. 1997 Mar;13(3):128-37. doi: 10.1016/s0885-3924(96)00316-8.
PubMed 9114631Bekker AY, Weeks EJ. Cognitive function after anaesthesia in the elderly. Best Pract Res Clin Anaesthesiol. 2003 Jun;17(2):259-72. doi: 10.1016/s1521-6896(03)00005-3.
PubMed 12817919Nishikawa K, Nakayama M, Omote K, Namiki A. Recovery characteristics and post-operative delirium after long-duration laparoscope-assisted surgery in elderly patients: propofol-based vs. sevoflurane-based anesthesia. Acta Anaesthesiol Scand. 2004 Feb;48(2):162-8. doi: 10.1111/j.0001-5172.2004.00264.x.
PubMed 14995937Inouye SK. Delirium in hospitalized elderly patients: recognition, evaluation, and management. Conn Med. 1993 May;57(5):309-15. No abstract available.
PubMed 8319447Inouye SK, Rushing JT, Foreman MD, Palmer RM, Pompei P. Does delirium contribute to poor hospital outcomes? A three-site epidemiologic study. J Gen Intern Med. 1998 Apr;13(4):234-42. doi: 10.1046/j.1525-1497.1998.00073.x.
PubMed 9565386McCusker J, Cole M, Abrahamowicz M, Primeau F, Belzile E. Delirium predicts 12-month mortality. Arch Intern Med. 2002 Feb 25;162(4):457-63. doi: 10.1001/archinte.162.4.457.
PubMed 11863480Inouye SK. Delirium in hospitalized older patients: recognition and risk factors. J Geriatr Psychiatry Neurol. 1998 Fall;11(3):118-25; discussion 157-8. doi: 10.1177/089198879801100302.
PubMed 9894730Breitbart W, Gibson C, Tremblay A. The delirium experience: delirium recall and delirium-related distress in hospitalized patients with cancer, their spouses/caregivers, and their nurses. Psychosomatics. 2002 May-Jun;43(3):183-94. doi: 10.1176/appi.psy.43.3.183.
PubMed 12075033Gustafson Y, Berggren D, Brannstrom B, Bucht G, Norberg A, Hansson LI, Winblad B. Acute confusional states in elderly patients treated for femoral neck fracture. J Am Geriatr Soc. 1988 Jun;36(6):525-30. doi: 10.1111/j.1532-5415.1988.tb04023.x.
PubMed 2897391Saravay SM, Strain JJ. APM Task Force on Funding Implications of Consultation-Liaison Outcome Studies. Special series introduction: a review of outcome studies. Psychosomatics. 1994 May-Jun;35(3):227-32. doi: 10.1016/S0033-3182(94)71771-0. No abstract available.
PubMed 8036252Thomas RI, Cameron DJ, Fahs MC. A prospective study of delirium and prolonged hospital stay. Exploratory study. Arch Gen Psychiatry. 1988 Oct;45(10):937-40. doi: 10.1001/archpsyc.1988.01800340065009.
PubMed 3138960Schor JD, Levkoff SE, Lipsitz LA, Reilly CH, Cleary PD, Rowe JW, Evans DA. Risk factors for delirium in hospitalized elderly. JAMA. 1992 Feb 12;267(6):827-31.
PubMed 1732655Cushman LA. Secondary neuropsychiatric complications in stroke: implications for acute care. Arch Phys Med Rehabil. 1988 Oct;69(10):877-9.
PubMed 3178456Kishi Y, Iwasaki Y, Takezawa K, Kurosawa H, Endo S. Delirium in critical care unit patients admitted through an emergency room. Gen Hosp Psychiatry. 1995 Sep;17(5):371-9. doi: 10.1016/0163-8343(95)00056-w.
PubMed 8522152
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Namenda as Prevention for Post-Operative Delirium
- ClinicalTrials.gov ID
- NCT00303433
- Acronym / sponsor ID
- RSRB-00012460
- Conditions
- Delirium, Post-Operative States
- Keywords
- Prevention, Post-Operative tates, Delirium, Namenda
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Mar 2006
- Study completion
- Sep 2006
- First posted
- 16 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post Operative Delirium is a common and serious risk of surgery. Delirium, when it occurs is associated with an increased risk of mortality, increase length of stay, and more adverse outcomes in general, including increased risk of higher level of care required at discharge.
Namenda, which is currently approved for moderate or severe Alzheimer's disease has a unique mechanism of action than other drugs for this condition. It may have the ability to protect the brain from more severe consequences of hypoxia, or hypoglycemia. Hence it is being looked at in this study to see if it can reduce the incidence and/or severity of delirium post-operatively.
Detailed description
Objectives of this double blind placebo-controlled study are to determine the efficacy, safety and tolerability of Namenda in the prevention of post-operative delirium as defined by DSM-IV-TR categories 293.0 Delirium due to medical condition or medications, and 780.09 Delirium NOS. The incidence of post-operative delirium is 10-50% of general surgical cases, depending on the population studied. Delirium is known to affect mortality and morbidity, and increase the length of stay of patients. Hospital mortality estimates in patients with delirium range from 10-65%, estimated to be 2-20 times that of control patients without delirium. Delirium is an independent prognostic determinant of hospital outcomes, including death, new nursing home placements and functional decline. Delirium is an independent marker for increased mortality among older medical inpatients in the 12 months post hospitalization, particularly in those patients without dementia.
Delirium may be better understood by a Multifactorial Model of Delirium, which involves a complex inter-relationship between predisposing Factors/Vulnerability and Precipitating Factors/Insults.
If higher risk factors can be identified, then preventive interventions targeted to these groups may be able to significantly reduce morbitity, possibly mortality, but at minimum improve the quality of life of those patients who otherwise would have gone through such an enormously traumatic and disturbing experience as the psychosis and disorientation of a delirium.
The Academy of Psyhosomatic Medicine Task Force on Mental Disorders in General Medical Practice, found that co-morbid delirium increased hospital length of stay: 100% in general medical inpatients, 114% in elderly patients, 67% in stroke patients, 300% in critical care patients, 27% in cardiac surgery patients, and 200-250% in hip surgery patients.
Overall Design and Plan of Study: 30 Surgical patients (type of elective surgery: total hip and total knee replacements) will be randomized into two arms of the study attempting to get a similar mean age for each group: Group 1: 15 patients receive placebo Day --8,--7,--6,--5,--4,--3,--2,--1,Day 0 (surgery), Post-op day 1,2,3, and 4. Group 2: 15 patients receive (10 mg) of Namenda (memantine) Day --8,--7,--6,--5,--4,--3,--2, then 20 mg per day on Day --1, day 0 (surgery), Post-op day 1,2,3 then 10 mg per day Post-op day 4, then stop Namenda.
Both groups will receive a MMSE, CLOX, Confusion Assessment Method (CAM) and the Delirium Rating Scale-Revised-98 Scale on day --8 (or before drug/placebo), day --1, then post-op day 1-6. Actigraphy will be performed day --8 through post-op day 6, and sleep diaries will be collected (subjected diaries pre-hospital day --8 through day --1, then objective diaries, day --1 through post-op day 6 in hospital).
Baseline screening blood tests will be drawn on all patients and include SMA-8 including BUN and creatinine, serum albumin, TSH, NH3 and baseline BP, Pulse and Temperature. Pre-op hematocrit has been shown to be a predictor as well, and may be worthwhile to follow up in these patients.
If delirium should develop in any patients, treatment will be as per usual standard of care, with likely psychiatric consultation and medications used will be tracked.
Pharmaco-economic arm (PEA) of syudy: We are working with hospital administration and will be able to obtain costs of care such as the following: room charges, locations (whether ICU, step-down unit or regular floor etc), pharmacy costs, cost of consultations needed, number of days in the hospital needed for each group. Discharge outcome (disposition, need for SNF vs. home, visiting nurse service needs) will be compared at discharge, and fo;;ow-up 30 days later.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medically stable
- 50 years of age or older
- having elective joint replacement surgery or other orthopedic procedures that are major surgery and require general anesthesia.
Key exclusion criteria (5 listed)
- Alcohol or sedative hypnotic abuse or dependence
- Pregnancy
- Dementia or MR/DD patients if they do not have sufficient capacity to understand the consent
- renal impairment or a creatinine of 1.4 or higher
- currently taking cholinesterase inhibitors.
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 |
|---|---|---|
| Namenda | Drug | – |
Primary outcome
Incidence and severity of delirium measured by Delirium Rating Scale-Revised-98, MMSE. Confusion Assessment Method, Clock Drawing Tests (CLOX), DSM-IV-TR criteria for Delirium.
1 secondary outcome
Length and cost of stay, disposition, level of care required post hosptialization, hospitalization satisfaction, number of consultants involved, total costs of care.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
- Background: PubMed 12075031Schwartz TL, Masand PS. The role of atypical antipsychotics in the treatment of delirium. Psychosomatics. 2002 May-Jun;43(3):171-4. doi: 10.1176/appi.psy.43.3.171.
- Background: PubMed 9114631Breitbart W, Rosenfeld B, Roth A, Smith MJ, Cohen K, Passik S. The Memorial Delirium Assessment Scale. J Pain Symptom Manage. 1997 Mar;13(3):128-37. doi: 10.1016/s0885-3924(96)00316-8.
- Background: PubMed 12817919Bekker AY, Weeks EJ. Cognitive function after anaesthesia in the elderly. Best Pract Res Clin Anaesthesiol. 2003 Jun;17(2):259-72. doi: 10.1016/s1521-6896(03)00005-3.
- Background: PubMed 14995937Nishikawa K, Nakayama M, Omote K, Namiki A. Recovery characteristics and post-operative delirium after long-duration laparoscope-assisted surgery in elderly patients: propofol-based vs. sevoflurane-based anesthesia. Acta Anaesthesiol Scand. 2004 Feb;48(2):162-8. doi: 10.1111/j.0001-5172.2004.00264.x.
- Background: PubMed 8319447Inouye SK. Delirium in hospitalized elderly patients: recognition, evaluation, and management. Conn Med. 1993 May;57(5):309-15. No abstract available.
- Background: PubMed 9565386Inouye SK, Rushing JT, Foreman MD, Palmer RM, Pompei P. Does delirium contribute to poor hospital outcomes? A three-site epidemiologic study. J Gen Intern Med. 1998 Apr;13(4):234-42. doi: 10.1046/j.1525-1497.1998.00073.x.
- Background: PubMed 11863480McCusker J, Cole M, Abrahamowicz M, Primeau F, Belzile E. Delirium predicts 12-month mortality. Arch Intern Med. 2002 Feb 25;162(4):457-63. doi: 10.1001/archinte.162.4.457.
- Background: PubMed 9894730Inouye SK. Delirium in hospitalized older patients: recognition and risk factors. J Geriatr Psychiatry Neurol. 1998 Fall;11(3):118-25; discussion 157-8. doi: 10.1177/089198879801100302.
- Background: PubMed 12075033Breitbart W, Gibson C, Tremblay A. The delirium experience: delirium recall and delirium-related distress in hospitalized patients with cancer, their spouses/caregivers, and their nurses. Psychosomatics. 2002 May-Jun;43(3):183-94. doi: 10.1176/appi.psy.43.3.183.
- Background: PubMed 2897391Gustafson Y, Berggren D, Brannstrom B, Bucht G, Norberg A, Hansson LI, Winblad B. Acute confusional states in elderly patients treated for femoral neck fracture. J Am Geriatr Soc. 1988 Jun;36(6):525-30. doi: 10.1111/j.1532-5415.1988.tb04023.x.
- Background: PubMed 8036252Saravay SM, Strain JJ. APM Task Force on Funding Implications of Consultation-Liaison Outcome Studies. Special series introduction: a review of outcome studies. Psychosomatics. 1994 May-Jun;35(3):227-32. doi: 10.1016/S0033-3182(94)71771-0. No abstract available.
- Background: PubMed 3138960Thomas RI, Cameron DJ, Fahs MC. A prospective study of delirium and prolonged hospital stay. Exploratory study. Arch Gen Psychiatry. 1988 Oct;45(10):937-40. doi: 10.1001/archpsyc.1988.01800340065009.
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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.
Michael R Privitera, MD principal investigator
University of Rochester
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 Namenda in people with Delirium and Post-Operative States, run by University of Rochester 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 3 inclusion and 5 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 3 Jun 2015. 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?
The study was stopped early. Results are not available in the source record.
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 and severity of delirium measured by Delirium Rating Scale-Revised-98, MMSE. Confusion Assessment Method, Clock Drawing Tests (CLOX), DSM-IV-TR criteria for Delirium.. 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 NCT00303433, which also lists 43 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 3 Jun 2015.