Drug InteractionsSEDDINCT00850330
Study for Early Detection of Drug Interactions in Older Hospitalized Patients Using on Line Software
An observational study of Drug Interactions, run by Universidad Nacional de Córdoba at 2 sites in Argentina.
Trial summary
A drug interaction (DI) is the mutual action of two drugs in a way that they can increase their action, even to a toxic level, or reduce it to its minimum. People elder than 65 years old have theirs biological ability to metabolized and eliminate drugs impaired. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Drug Interactions
- What is being tested?
- on line software to detect DI early on
- How many people
- 3,000 participants
- Where
- 2 sitesArgentina
- Study dates
- Jun 2009to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Hospitalized patients older than 65 years old
Who may be able to join
- Hospitalization
- 65 years old or more
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Argentina2 sites, 2 recruiting
- Recruiting
Clínica Privada Colombo
Córdoba, Córdoba Province, x5000
Marcelo Dellatorre, M.D., 543514891398, secretaria@fundcolombodiaz.org.ar
Herminia Cesca, M.D.
- Not yet recruiting
Hospital Nacional de Clínicas
Córdoba, Córdoba Province, x5009
Gabriel S Iraci, MD, Prof, 54 0351 489 9454, gabysi_01@yahoo.com
About this study
Official title: Transversal, Multicentric Study for Early Detection of Drug Interactions in Older Hospitalized Patients Using on Line Software in Córdoba, Argentina
A drug interaction (DI) is the mutual action of two drugs in a way that they can increase their action, even to a toxic level, or reduce it to its minimum.
People elder than 65 years old have theirs biological ability to metabolized and eliminate drugs impaired. Even more, they tend to suffer from many diseases, are treated for many physicians, and receive many drugs for those conditions. If hospitalized older people are prone to receive a greater number of drugs. This scenario is the worst to suffer from adverse drug events and DI, which in turn compromise more the health and even life of hospitalized older people.
Many computerized strategies have been developed to prevent those problems. In this trial the investigators use on line software to early detect DI that could endanger health or life of hospitalized older patients.
Read the detailed description
A drug interaction (DI) is the mutual action of two drugs in a way that they can increase their action, even to a toxic level, o reduce it to its minimum.
Adverse drug events (ADE) are an important health problem. In the book To Err Is Human: Building a Safer Health System its authors Kohn, Corrigan and Donaldson from the "Committee on Quality of Health Care in America, Institute of Medicine" (U.S.A.) expressed that 2 out of every 100 hospital admissions were due to ADE. That results in an average increase of U$D 4,700 extra for each admission or about to 2.8 million U$D annually for a 700-bed teaching hospital. In this study were only considered direct costs. No indirect costs were taken into account, like days out of work, rehabilitation, deaths, lost of quality of life, etc.
In 2003, in a cohort study done in people of Medicare elder than 65 years old, were detected 50.1 ADE / 1000 persons a year. Of that number of ADE 13.8 were considered preventable. In Switzerland 3.3 % of hospitalisations were considered due to ADE.
Among ADE, DI are a very important part of the problem. In Canada was demonstrated that certain drug associations were responsible of an increase in the number of hospital admissions. They would not have occurred if those prescriptions would have been properly controlled or never done. In Mexico 3.8 % of patients elder than 50 years old received prescriptions of drugs, which should be avoided according to their interaction. In hospital setting DI endanger even more health and people's life. In Spain was demonstrated a prevalence of clinical relevant DI of 3 % in hospitalized patients, and in Switzerland that percentage rose 11 %. This phenomenon increased in later years, in Rotterdam DI compromising lethal risk in patients elder than 70 years old, climb from 1.5 % in 1992 to 2.9 % in 2005. Drug interactions are directly proportional to: the number of administered drugs (> 2 drugs or > 4 ); the age of patients and the number of prescribing physicians.
Older persons, for its detriment in physical condition and the pathologies they suffer from, are prone to suffer DI when being prescribed with drugs or even herbal medicines. In Brazil ambulatory patients elder than 60 years old have 2.5 pathologies diagnosed and consume in average 1.3 to 2.3 drugs. During hospitalisation the number of prescribed drugs reach 9.9 to 13.6 per patient. In a survey done in six European countries the number of drugs consumed for each ambulatory patient was 7. In Argentina according to the Instituto Nacional de Estadísticas y Censos (INDEC) the number of citizens elder than 65 years old was 3,587,620 (9.89% total population). Unfortunately there is no other information about polypharmacy or prevalent pathologies in INDEC or other medical databases or national institutions web sites.
In 1995, it was published an article in JAMA that stated the possibility that 28 % of ADE could be prevented in non-obstetric hospitalized adults. Fifty six percent of those were due to mistakes done during prescription, 34 % during administration, 6 % during transcription of indications and 4 % during dispensation. This astonishing results poses on the need to develop strategies to cut this numbers.
Many lists of drugs with potential to produce ADE were developed to prevent DI and other related drugs damages. Beers criteria (BC) is one example of them. In Amsterdam it was demonstrated an 80 % improvement in drug regimens in patients elder than 81 years old of in whom their therapeutic indications were reviewed and adjusted using BC and the Medication Appropriateness Index after suffering from ADE. In that study, a list of only 10 drug combinations was also used but did not showed the same benefits. In Argentina, the Adminstración Nacional de Medicamentos, Alimentos y Tecnología (ANMAT) publish in its web page a list of 16 risky drugs, considering the disadvantages of their own pharmacological action, but there is no information about its usefulness.
Much software was developed in later years to alert physician about DI. Some of them are even more sensible than the search of DI at the bedside, but this software overestimates the prevalence of serious DI. The usage of computerized alert systems for prescriptions significantly reduced potential ADE, however many physicians tend to override them for different reasons. Finally a Cochrane´s review showed a reduction in hospitalization days and drug toxic effects when using a computerized warning systems for drug dosing.
The growing number of drugs, apart from its not always well-proven benefits, implies risks for health; specially in sick and older people and even more during hospitalizations. Nowadays software to alert physicians about DI or ADE could help to prevent them but its real contribution is still a matter of debate. For this reasons we developed this trial to test the usefulness of on line software to detect DI in hospitalized elder patients.
- Conditions
- Drug Interactions
- Being tested
- on line software to detect DI early on
- Keywords
- Drug interactions, Drug interaction software, Older patients, Hospitalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
on line software to detect DI early onOther
Also called Software are available on:, http://www.medscape.com/druginfo/druginterchecker, http://www.medicamentosrothlin.com.ar/
Patients hospital records will be reviewed on the day of admission to assess all their indication using on line software to early detect drug interactions.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized patients | Patients elder than 65 years old hospitalized for any reason. Receives: Other: on line software to detect DI early on |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early detect DI in hospitalized elder patients
Measured: One year and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Drug InteractionsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Córdoba
- Sponsor type
- University, hospital or other
- Investigators
- Gabriel S Iraci, MD, Prof, Principal investigator, Catedra de Farmacología, Hospital Nacional de Clínicas, Universidad Nacional de Córdoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850330
- Sponsor's protocol ID
- Iraci-01
- Acronym
- SEDDI
- Status last verified
- Aug 2009
- First submitted
- 20 Feb 2009
- Last updated
- 4 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Gurwitz JH, Field TS, Harrold LR, Rothschild J, Debellis K, Seger AC, Cadoret C, Fish LS, Garber L, Kelleher M, Bates DW. Incidence and preventability of adverse drug events among older persons in the ambulatory setting. JAMA. 2003 Mar 5;289(9):1107-16. doi: 10.1001/jama.289.9.1107.
PubMed 12622580Fattinger K, Roos M, Vergeres P, Holenstein C, Kind B, Masche U, Stocker DN, Braunschweig S, Kullak-Ublick GA, Galeazzi RL, Follath F, Gasser T, Meier PJ. Epidemiology of drug exposure and adverse drug reactions in two swiss departments of internal medicine. Br J Clin Pharmacol. 2000 Feb;49(2):158-67. doi: 10.1046/j.1365-2125.2000.00132.x.
PubMed 10671911Juurlink DN, Mamdani M, Kopp A, Laupacis A, Redelmeier DA. Drug-drug interactions among elderly patients hospitalized for drug toxicity. JAMA. 2003 Apr 2;289(13):1652-8. doi: 10.1001/jama.289.13.1652.
PubMed 12672733Doubova Dubova SV, Reyes-Morales H, Torres-Arreola Ldel P, Suarez-Ortega M. Potential drug-drug and drug-disease interactions in prescriptions for ambulatory patients over 50 years of age in family medicine clinics in Mexico City. BMC Health Serv Res. 2007 Sep 19;7:147. doi: 10.1186/1472-6963-7-147.
PubMed 17880689Peral Aguirregoitia J, Lertxundi Etxebarria U, Martinez Bengoechea MJ, Mora Atorrasagasti O, Franco Lamela E, Gabilondo Zelaia I. [Prospective assessment of drug interactions in hospitalized patients using a computer programme]. Farm Hosp. 2007 Mar-Apr;31(2):93-100. doi: 10.1016/s1130-6343(07)75719-7. Spanish.
PubMed 17590117Becker ML, Visser LE, van Gelder T, Hofman A, Stricker BH. Increasing exposure to drug-drug interactions between 1992 and 2005 in people aged > or = 55 years. Drugs Aging. 2008;25(2):145-52. doi: 10.2165/00002512-200825020-00006.
PubMed 18257601Preskorn SH, Silkey B, Shah R, Neff M, Jones TL, Choi J, Golbeck AL. Complexity of medication use in the Veterans Affairs healthcare system: Part I: Outpatient use in relation to age and number of prescribers. J Psychiatr Pract. 2005 Jan;11(1):5-15. doi: 10.1097/00131746-200501000-00002.
PubMed 15650617Marin MJ, Cecilio LC, Perez AE, Santella F, Silva CB, Goncalves Filho JR, Roceti LC. [Use of medicines by the elderly in a Family Health Program unit in Brazil]. Cad Saude Publica. 2008 Jul;24(7):1545-55. doi: 10.1590/s0102-311x2008000700009. Portuguese.
PubMed 18670678Medeiros-Souza P, Santos-Neto LL, Kusano LT, Pereira MG. Diagnosis and control of polypharmacy in the elderly. Rev Saude Publica. 2007 Dec;41(6):1049-53. doi: 10.1590/s0034-89102006005000050. Epub 2007 Dec 4.
PubMed 17992356Bjorkman IK, Fastbom J, Schmidt IK, Bernsten CB; Pharmaceutical Care of the Elderly in Europe Research (PEER) Group. Drug-drug interactions in the elderly. Ann Pharmacother. 2002 Nov;36(11):1675-81. doi: 10.1345/aph.1A484.
PubMed 12398558Bates DW, Cullen DJ, Laird N, Petersen LA, Small SD, Servi D, Laffel G, Sweitzer BJ, Shea BF, Hallisey R, et al. Incidence of adverse drug events and potential adverse drug events. Implications for prevention. ADE Prevention Study Group. JAMA. 1995 Jul 5;274(1):29-34.
PubMed 7791255Fick DM, Cooper JW, Wade WE, Waller JL, Maclean JR, Beers MH. Updating the Beers criteria for potentially inappropriate medication use in older adults: results of a US consensus panel of experts. Arch Intern Med. 2003 Dec 8-22;163(22):2716-24. doi: 10.1001/archinte.163.22.2716.
PubMed 14662625Tulner LR, Frankfort SV, Gijsen GJ, van Campen JP, Koks CH, Beijnen JH. Drug-drug interactions in a geriatric outpatient cohort: prevalence and relevance. Drugs Aging. 2008;25(4):343-55. doi: 10.2165/00002512-200825040-00007.
PubMed 18361544Bates DW, Leape LL, Cullen DJ, Laird N, Petersen LA, Teich JM, Burdick E, Hickey M, Kleefield S, Shea B, Vander Vliet M, Seger DL. Effect of computerized physician order entry and a team intervention on prevention of serious medication errors. JAMA. 1998 Oct 21;280(15):1311-6. doi: 10.1001/jama.280.15.1311.
PubMed 9794308Durieux P, Trinquart L, Colombet I, Nies J, Walton R, Rajeswaran A, Rege Walther M, Harvey E, Burnand B. Computerized advice on drug dosage to improve prescribing practice. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD002894. doi: 10.1002/14651858.CD002894.pub2.
PubMed 18646085
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversal, Multicentric Study for Early Detection of Drug Interactions in Older Hospitalized Patients Using on Line Software in Córdoba, Argentina
- ClinicalTrials.gov ID
- NCT00850330
- Acronym / sponsor ID
- SEDDI / Iraci-01
- Conditions
- Drug Interactions
- Keywords
- Drug interactions, Drug interaction software, Older patients, Hospitalization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Universidad Nacional de CórdobaUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 25 Feb 2009 (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.
A drug interaction (DI) is the mutual action of two drugs in a way that they can increase their action, even to a toxic level, or reduce it to its minimum.
People elder than 65 years old have theirs biological ability to metabolized and eliminate drugs impaired. Even more, they tend to suffer from many diseases, are treated for many physicians, and receive many drugs for those conditions. If hospitalized older people are prone to receive a greater number of drugs. This scenario is the worst to suffer from adverse drug events and DI, which in turn compromise more the health and even life of hospitalized older people.
Many computerized strategies have been developed to prevent those problems. In this trial the investigators use on line software to early detect DI that could endanger health or life of hospitalized older patients.
Detailed description
A drug interaction (DI) is the mutual action of two drugs in a way that they can increase their action, even to a toxic level, o reduce it to its minimum.
Adverse drug events (ADE) are an important health problem. In the book To Err Is Human: Building a Safer Health System its authors Kohn, Corrigan and Donaldson from the "Committee on Quality of Health Care in America, Institute of Medicine" (U.S.A.) expressed that 2 out of every 100 hospital admissions were due to ADE. That results in an average increase of U$D 4,700 extra for each admission or about to 2.8 million U$D annually for a 700-bed teaching hospital. In this study were only considered direct costs. No indirect costs were taken into account, like days out of work, rehabilitation, deaths, lost of quality of life, etc.
In 2003, in a cohort study done in people of Medicare elder than 65 years old, were detected 50.1 ADE / 1000 persons a year. Of that number of ADE 13.8 were considered preventable. In Switzerland 3.3 % of hospitalisations were considered due to ADE.
Among ADE, DI are a very important part of the problem. In Canada was demonstrated that certain drug associations were responsible of an increase in the number of hospital admissions. They would not have occurred if those prescriptions would have been properly controlled or never done. In Mexico 3.8 % of patients elder than 50 years old received prescriptions of drugs, which should be avoided according to their interaction. In hospital setting DI endanger even more health and people's life. In Spain was demonstrated a prevalence of clinical relevant DI of 3 % in hospitalized patients, and in Switzerland that percentage rose 11 %. This phenomenon increased in later years, in Rotterdam DI compromising lethal risk in patients elder than 70 years old, climb from 1.5 % in 1992 to 2.9 % in 2005. Drug interactions are directly proportional to: the number of administered drugs (> 2 drugs or > 4 ); the age of patients and the number of prescribing physicians.
Older persons, for its detriment in physical condition and the pathologies they suffer from, are prone to suffer DI when being prescribed with drugs or even herbal medicines. In Brazil ambulatory patients elder than 60 years old have 2.5 pathologies diagnosed and consume in average 1.3 to 2.3 drugs. During hospitalisation the number of prescribed drugs reach 9.9 to 13.6 per patient. In a survey done in six European countries the number of drugs consumed for each ambulatory patient was 7. In Argentina according to the Instituto Nacional de Estadísticas y Censos (INDEC) the number of citizens elder than 65 years old was 3,587,620 (9.89% total population). Unfortunately there is no other information about polypharmacy or prevalent pathologies in INDEC or other medical databases or national institutions web sites.
In 1995, it was published an article in JAMA that stated the possibility that 28 % of ADE could be prevented in non-obstetric hospitalized adults. Fifty six percent of those were due to mistakes done during prescription, 34 % during administration, 6 % during transcription of indications and 4 % during dispensation. This astonishing results poses on the need to develop strategies to cut this numbers.
Many lists of drugs with potential to produce ADE were developed to prevent DI and other related drugs damages. Beers criteria (BC) is one example of them. In Amsterdam it was demonstrated an 80 % improvement in drug regimens in patients elder than 81 years old of in whom their therapeutic indications were reviewed and adjusted using BC and the Medication Appropriateness Index after suffering from ADE. In that study, a list of only 10 drug combinations was also used but did not showed the same benefits. In Argentina, the Adminstración Nacional de Medicamentos, Alimentos y Tecnología (ANMAT) publish in its web page a list of 16 risky drugs, considering the disadvantages of their own pharmacological action, but there is no information about its usefulness.
Much software was developed in later years to alert physician about DI. Some of them are even more sensible than the search of DI at the bedside, but this software overestimates the prevalence of serious DI. The usage of computerized alert systems for prescriptions significantly reduced potential ADE, however many physicians tend to override them for different reasons. Finally a Cochrane´s review showed a reduction in hospitalization days and drug toxic effects when using a computerized warning systems for drug dosing.
The growing number of drugs, apart from its not always well-proven benefits, implies risks for health; specially in sick and older people and even more during hospitalizations. Nowadays software to alert physicians about DI or ADE could help to prevent them but its real contribution is still a matter of debate. For this reasons we developed this trial to test the usefulness of on line software to detect DI in hospitalized elder patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized patients | – | Other: on line software to detect DI early onPatients elder than 65 years old hospitalized for any reason. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Hospitalized patients older than 65 years old
Key inclusion criteria (2 listed)
- Hospitalization
- 65 years old or more
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| on line software to detect DI early onAlso: Software are available on:, http://www.medscape.com/druginfo/druginterchecker, http://www.medicamentosrothlin.com.ar/Patients hospital records will be reviewed on the day of admission to assess all their indication using on line software to early detect drug interactions. | Other | Hospitalized patients |
Primary outcome
Early detect DI in hospitalized elder patients
Time frame: One year and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2009.
- Background: PubMed 12622580Gurwitz JH, Field TS, Harrold LR, Rothschild J, Debellis K, Seger AC, Cadoret C, Fish LS, Garber L, Kelleher M, Bates DW. Incidence and preventability of adverse drug events among older persons in the ambulatory setting. JAMA. 2003 Mar 5;289(9):1107-16. doi: 10.1001/jama.289.9.1107.
- Background: PubMed 10671911Fattinger K, Roos M, Vergeres P, Holenstein C, Kind B, Masche U, Stocker DN, Braunschweig S, Kullak-Ublick GA, Galeazzi RL, Follath F, Gasser T, Meier PJ. Epidemiology of drug exposure and adverse drug reactions in two swiss departments of internal medicine. Br J Clin Pharmacol. 2000 Feb;49(2):158-67. doi: 10.1046/j.1365-2125.2000.00132.x.
- Background: PubMed 12672733Juurlink DN, Mamdani M, Kopp A, Laupacis A, Redelmeier DA. Drug-drug interactions among elderly patients hospitalized for drug toxicity. JAMA. 2003 Apr 2;289(13):1652-8. doi: 10.1001/jama.289.13.1652.
- Background: PubMed 17880689Doubova Dubova SV, Reyes-Morales H, Torres-Arreola Ldel P, Suarez-Ortega M. Potential drug-drug and drug-disease interactions in prescriptions for ambulatory patients over 50 years of age in family medicine clinics in Mexico City. BMC Health Serv Res. 2007 Sep 19;7:147. doi: 10.1186/1472-6963-7-147.
- Background: PubMed 17590117Peral Aguirregoitia J, Lertxundi Etxebarria U, Martinez Bengoechea MJ, Mora Atorrasagasti O, Franco Lamela E, Gabilondo Zelaia I. [Prospective assessment of drug interactions in hospitalized patients using a computer programme]. Farm Hosp. 2007 Mar-Apr;31(2):93-100. doi: 10.1016/s1130-6343(07)75719-7. Spanish.
- Background: PubMed 18257601Becker ML, Visser LE, van Gelder T, Hofman A, Stricker BH. Increasing exposure to drug-drug interactions between 1992 and 2005 in people aged > or = 55 years. Drugs Aging. 2008;25(2):145-52. doi: 10.2165/00002512-200825020-00006.
- Background: PubMed 15650617Preskorn SH, Silkey B, Shah R, Neff M, Jones TL, Choi J, Golbeck AL. Complexity of medication use in the Veterans Affairs healthcare system: Part I: Outpatient use in relation to age and number of prescribers. J Psychiatr Pract. 2005 Jan;11(1):5-15. doi: 10.1097/00131746-200501000-00002.
- Background: PubMed 18670678Marin MJ, Cecilio LC, Perez AE, Santella F, Silva CB, Goncalves Filho JR, Roceti LC. [Use of medicines by the elderly in a Family Health Program unit in Brazil]. Cad Saude Publica. 2008 Jul;24(7):1545-55. doi: 10.1590/s0102-311x2008000700009. Portuguese.
- Background: PubMed 17992356Medeiros-Souza P, Santos-Neto LL, Kusano LT, Pereira MG. Diagnosis and control of polypharmacy in the elderly. Rev Saude Publica. 2007 Dec;41(6):1049-53. doi: 10.1590/s0034-89102006005000050. Epub 2007 Dec 4.
- Background: PubMed 12398558Bjorkman IK, Fastbom J, Schmidt IK, Bernsten CB; Pharmaceutical Care of the Elderly in Europe Research (PEER) Group. Drug-drug interactions in the elderly. Ann Pharmacother. 2002 Nov;36(11):1675-81. doi: 10.1345/aph.1A484.
- Background: PubMed 7791255Bates DW, Cullen DJ, Laird N, Petersen LA, Small SD, Servi D, Laffel G, Sweitzer BJ, Shea BF, Hallisey R, et al. Incidence of adverse drug events and potential adverse drug events. Implications for prevention. ADE Prevention Study Group. JAMA. 1995 Jul 5;274(1):29-34.
- Background: PubMed 14662625Fick DM, Cooper JW, Wade WE, Waller JL, Maclean JR, Beers MH. Updating the Beers criteria for potentially inappropriate medication use in older adults: results of a US consensus panel of experts. Arch Intern Med. 2003 Dec 8-22;163(22):2716-24. doi: 10.1001/archinte.163.22.2716.
- Software to check multiple drug interactions. (Needs registration)Link provided by the sponsor.
- Free software in spanish to check drug interactions on lineLink provided by the sponsor.
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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.
Gabriel S Iraci, MD, Prof principal investigator
Catedra de Farmacología, Hospital Nacional de Clínicas, Universidad Nacional de Córdoba
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Interactions, run by Universidad Nacional de Córdoba at 2 sites in Argentina.
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 2 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: status not confirmed, as of the sponsor's last update on 4 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriel S Iraci, MD, Prof (54 0351 489 9454, gabysi_01@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early detect DI in hospitalized elder patients (time frame: One year and 6 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 NCT00850330, which also lists 17 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 4 Aug 2009.