Cost-effectiveness AnalysisNCT03474367
Cost-effectiveness of Urgent-start Therapies Hemodialysis and Peritoneal Dialysis
An observational study of Cost-effectiveness Analysis and Chronic Kidney Disease Requiring Chronic Dialysis, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
Trial summary
This study will evaluate the cost-effectiveness of unplanned dialysis (peritoneal dialysis and hemodialysis) in chronic kidney disease (CKD) during the first year of therapy in a single center. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cost-effectiveness Analysis, Chronic Kidney Disease Requiring Chronic Dialysis
- How many people
- 198 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2017to 12 Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Incident dialysis patients.
Who may be able to join
- Ambulatorial Chronic Kidney Disease patients stage 5 (eGFR < 15 ml/min) or stages 4 with abrupt worsening requiring dialysis treatment immediately followed or not by nephrologists prior to Renal Replacement Therapy indication.
Who cannot join
- Transitions between HD and PD
- Patients with functional arteriovenous fistula entering hemodialysis
- Patients with functional PD access implanted ate least 48h before the first use
- Patient or family trained in PD and/or with the right adequacy of the home
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da Faculdade de Medicina de Botucatu
Botucatu, São Paulo, 18606-260
About this study
This study will evaluate the cost-effectiveness of unplanned dialysis (peritoneal dialysis and hemodialysis) in chronic kidney disease (CKD) during the first year of therapy in a single center.
Read the detailed description
Despite evidence of worse outcomes, initiation of renal replacement therapy by unplanned modalities in chronic kidney disease (CKD) patients is the reality in the practice for both hemodialysis and peritoneal dialysis. Unplanned therapy peritoneal dialysis (PD) is the initiation of the modality in less than 48 hours after implantation of the peritoneal catheter, without family training or adequacy of the home. Unplanned hemodialysis (HD) is the initiation of the method without a functional arteriovenous fistula, i.e., with a central venous catheter (nontunneled or tunneled).
Growing evidence shows unplanned PD (or urgent start PD) as a viable and safe alternative to unplanned HD, with the similar rates of infection and survival.
On planned scenario, solid studies demonstrate that PD has a better cost-effectiveness when compared to HD, however the literature lacks in this kind of analysis in unplanned methods.
Briefly, the workgroup will follow patients that would anyway start a Renal Replacement Therapy by an unplanned method and register Government payment for the therapy, including the therapy direct costs and the costs with events (internation, infection), access for dialysis, laboratory and CKD specific medications to performed a cost-effectiveness analysis in both groups (Unplanned Hemodialysis and Unplanned Peritoneal Dialysis).
The workgroup is responsible for the placement of the catheters (PD and HD) using the Seldinger Technique.
The study is unicentric, the therapy is continuous and necessary for the maintenance of life; therefore, no great difficult in the follow up is expected. A database with up-to-date information of patients will be functional during the study.
A Markov model will be developed to assess the relative cost-effectiveness of different dialysis modality distribution scenarios versus current practice. The model considers a hypothetical adult incident patient cohort with end-stage renal disease (ESRD) requiring dialysis and adopts payer perspective. Markov models have been used to model dialysis treatment in previous economic analyses and are widely accepted to be suitable for modelling chronic condition
Statistical analysis plan:
From the study protocol, the data will be entered in a spreadsheet and verified typographical errors and their analysis will be performed using the statistical program Statistical Analysis System (SAS) for Windows (version 9.2: SAS Institute, Cary, North Carolina, USA, 2012).
Considering an alpha error of 0.05 and a beta error of 0.2, power of statistic test of 0.8 and cost difference detection between groups of 15%, the calculated sample size for each group is 94 patients.
Initially descriptive analysis will be done for all patients treated in the period, calculated measures of central tendency and dispersion for continuous variables and frequencies for categorical variables.
For the analysis of repeated measures, asymmetric distribution (gamma) under the Generalized Linear Model (GENMOD) procedure will be used.
Chi Square will be used to compare categorical variable between the two groups. T test or Mann-Whitney will be used to compare parametric continue variables.
By the utilization of Kaplan Meyer and log rank, survival curves of the two groups will be presented at the end of the study. A p-value of 5% or lower will be considered to be statistically significant
- Keywords
- Unplanned Peritoneal Dialysis, Unplanned Hemodialysis, Cost-Benefit Analysis, Dialysis, Peritoneal Dialysis, Hemodialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Unplanned Peritoneal Dialysis | CKD patients stage 5 (eGFR < 15 ml/min/1,73m²) or stages 4 with abrupt worsening renal function requiring dialysis treatment immediately, followed or not by nephrologists prior to renal replacement therapy (RRT) indication, that agree to initiate peritoneal dialysis (PD) in less than 48 hours after implantation of the peritoneal catheter, without family training or adequacy of the home. The patient must not have any absolute contraindications to initiate PD, which include: presence of recent abdominal surgery (less than 30 days); multiple previous abdominal surgery (more than two); presence of fibrosis or peritoneal adhesions; fungal peritonitis; severe respiratory insufficiency (FiO2> 70%); abdominal infections; severe hyperkalemia with changes characteristic in ECG; and acute pulmonary edema. These patients will be treated with HD. | |
| Unplanned Hemodialysis | CKD patients stage 5 (eGFR < 15 ml/min/1,73m²) or stages 4 with abrupt worsening renal function requiring dialysis treatment immediately, followed or not by nephrologists prior to renal replacement therapy (RRT) indication, that agree to initiate HD without a functional arteriovenous fistula, ie, with a central venous catheter (nontunneled or tunneled). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost effectiveness analysis of unplanned PD and HD at the General Hospital of the School of Medicine of Botucatu (HC-FMB)
Cost effectiveness analysis of unplanned PD and HD with the data collected at our center
Measured: 12 months
Secondary outcomes (1)
Cost effectiveness analysis of unplanned PD and HD in national and international scenario
Transpose the cost-effectiveness analysis to a national and international scenario, using a Markov model
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start1 Apr 2017
- Primary completion12 Mar 2020 (estimated)
- Study completion12 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Cost-effectiveness AnalysisStudies 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
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre Minetto Brabo, Universidade Estadual Paulista Júlio de Mesquita Filho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474367
- Sponsor's protocol ID
- 97/2017
- Status last verified
- Sep 2019
- First submitted
- 28 Jun 2017
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Woo KT, Choong HL, Wong KS, Tan HB, Chan CM. The contribution of chronic kidney disease to the global burden of major noncommunicable diseases. Kidney Int. 2012 May;81(10):1044-1045. doi: 10.1038/ki.2012.39. No abstract available.
PubMed 22543907Eggers PW. Has the incidence of end-stage renal disease in the USA and other countries stabilized? Curr Opin Nephrol Hypertens. 2011 May;20(3):241-5. doi: 10.1097/MNH.0b013e3283454319.
PubMed 21422925Klarenbach SW, Tonelli M, Chui B, Manns BJ. Economic evaluation of dialysis therapies. Nat Rev Nephrol. 2014 Nov;10(11):644-52. doi: 10.1038/nrneph.2014.145. Epub 2014 Aug 26.
PubMed 25157840Haller M, Gutjahr G, Kramar R, Harnoncourt F, Oberbauer R. Cost-effectiveness analysis of renal replacement therapy in Austria. Nephrol Dial Transplant. 2011 Sep;26(9):2988-95. doi: 10.1093/ndt/gfq780. Epub 2011 Feb 10.
PubMed 21310740Howard K, Salkeld G, White S, McDonald S, Chadban S, Craig JC, Cass A. The cost-effectiveness of increasing kidney transplantation and home-based dialysis. Nephrology (Carlton). 2009 Feb;14(1):123-32. doi: 10.1111/j.1440-1797.2008.01073.x.
PubMed 19207859Korevaar JC, Feith GW, Dekker FW, van Manen JG, Boeschoten EW, Bossuyt PM, Krediet RT; NECOSAD Study Group. Effect of starting with hemodialysis compared with peritoneal dialysis in patients new on dialysis treatment: a randomized controlled trial. Kidney Int. 2003 Dec;64(6):2222-8. doi: 10.1046/j.1523-1755.2003.00321.x.
PubMed 14633146Vonesh EF, Snyder JJ, Foley RN, Collins AJ. Mortality studies comparing peritoneal dialysis and hemodialysis: what do they tell us? Kidney Int Suppl. 2006 Nov;(103):S3-11. doi: 10.1038/sj.ki.5001910.
PubMed 17080109Perl J, Wald R, McFarlane P, Bargman JM, Vonesh E, Na Y, Jassal SV, Moist L. Hemodialysis vascular access modifies the association between dialysis modality and survival. J Am Soc Nephrol. 2011 Jun;22(6):1113-21. doi: 10.1681/ASN.2010111155. Epub 2011 Apr 21.
PubMed 21511830Heaf JG, Lokkegaard H, Madsen M. Initial survival advantage of peritoneal dialysis relative to haemodialysis. Nephrol Dial Transplant. 2002 Jan;17(1):112-7. doi: 10.1093/ndt/17.1.112.
PubMed 11773473Termorshuizen F, Korevaar JC, Dekker FW, Van Manen JG, Boeschoten EW, Krediet RT; Netherlands Cooperative Study on the Adequacy of Dialysis Study Group. Hemodialysis and peritoneal dialysis: comparison of adjusted mortality rates according to the duration of dialysis: analysis of The Netherlands Cooperative Study on the Adequacy of Dialysis 2. J Am Soc Nephrol. 2003 Nov;14(11):2851-60. doi: 10.1097/01.asn.0000091585.45723.9e.
PubMed 14569095Dias DB, Banin V, Mendes ML, Barretti P, Ponce D. Peritoneal dialysis can be an option for unplanned chronic dialysis: initial results from a developing country. Int Urol Nephrol. 2016 Jun;48(6):901-6. doi: 10.1007/s11255-016-1243-x. Epub 2016 Feb 20.
PubMed 26897038Silva TN, de Marchi D, Mendes ML, Barretti P, Ponce D. Approach to prophylactic measures for central venous catheter-related infections in hemodialysis: a critical review. Hemodial Int. 2014 Jan;18(1):15-23. doi: 10.1111/hdi.12071. Epub 2013 Aug 14.
PubMed 23944971Mendes ML, Castro JH, Silva TN, Barretti P, Ponce D. Effective use of alteplase for occluded tunneled venous catheter in hemodialysis patients. Artif Organs. 2014 May;38(5):399-403. doi: 10.1111/aor.12186. Epub 2013 Oct 3.
PubMed 24117542Koch M, Kohnle M, Trapp R, Haastert B, Rump LC, Aker S. Comparable outcome of acute unplanned peritoneal dialysis and haemodialysis. Nephrol Dial Transplant. 2012 Jan;27(1):375-80. doi: 10.1093/ndt/gfr262. Epub 2011 May 28.
PubMed 21622993Lobbedez T, Lecouf A, Ficheux M, Henri P, Hurault de Ligny B, Ryckelynck JP. Is rapid initiation of peritoneal dialysis feasible in unplanned dialysis patients? A single-centre experience. Nephrol Dial Transplant. 2008 Oct;23(10):3290-4. doi: 10.1093/ndt/gfn213. Epub 2008 Apr 19.
PubMed 18424817
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness of Urgent-start Therapies Hemodialysis and Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT03474367
- Acronym / sponsor ID
- 97/2017
- Keywords
- Unplanned Peritoneal Dialysis, Unplanned Hemodialysis, Cost-Benefit Analysis, Dialysis, Peritoneal Dialysis, Hemodialysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 12 Mar 2020 (estimated)
- Study completion
- 12 Dec 2021 (estimated)
- First posted
- 22 Mar 2018 (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.
This study will evaluate the cost-effectiveness of unplanned dialysis (peritoneal dialysis and hemodialysis) in chronic kidney disease (CKD) during the first year of therapy in a single center.
Detailed description
Despite evidence of worse outcomes, initiation of renal replacement therapy by unplanned modalities in chronic kidney disease (CKD) patients is the reality in the practice for both hemodialysis and peritoneal dialysis. Unplanned therapy peritoneal dialysis (PD) is the initiation of the modality in less than 48 hours after implantation of the peritoneal catheter, without family training or adequacy of the home. Unplanned hemodialysis (HD) is the initiation of the method without a functional arteriovenous fistula, i.e., with a central venous catheter (nontunneled or tunneled).
Growing evidence shows unplanned PD (or urgent start PD) as a viable and safe alternative to unplanned HD, with the similar rates of infection and survival.
On planned scenario, solid studies demonstrate that PD has a better cost-effectiveness when compared to HD, however the literature lacks in this kind of analysis in unplanned methods.
Briefly, the workgroup will follow patients that would anyway start a Renal Replacement Therapy by an unplanned method and register Government payment for the therapy, including the therapy direct costs and the costs with events (internation, infection), access for dialysis, laboratory and CKD specific medications to performed a cost-effectiveness analysis in both groups (Unplanned Hemodialysis and Unplanned Peritoneal Dialysis).
The workgroup is responsible for the placement of the catheters (PD and HD) using the Seldinger Technique.
The study is unicentric, the therapy is continuous and necessary for the maintenance of life; therefore, no great difficult in the follow up is expected. A database with up-to-date information of patients will be functional during the study.
A Markov model will be developed to assess the relative cost-effectiveness of different dialysis modality distribution scenarios versus current practice. The model considers a hypothetical adult incident patient cohort with end-stage renal disease (ESRD) requiring dialysis and adopts payer perspective. Markov models have been used to model dialysis treatment in previous economic analyses and are widely accepted to be suitable for modelling chronic condition
Statistical analysis plan:
From the study protocol, the data will be entered in a spreadsheet and verified typographical errors and their analysis will be performed using the statistical program Statistical Analysis System (SAS) for Windows (version 9.2: SAS Institute, Cary, North Carolina, USA, 2012).
Considering an alpha error of 0.05 and a beta error of 0.2, power of statistic test of 0.8 and cost difference detection between groups of 15%, the calculated sample size for each group is 94 patients.
Initially descriptive analysis will be done for all patients treated in the period, calculated measures of central tendency and dispersion for continuous variables and frequencies for categorical variables.
For the analysis of repeated measures, asymmetric distribution (gamma) under the Generalized Linear Model (GENMOD) procedure will be used.
Chi Square will be used to compare categorical variable between the two groups. T test or Mann-Whitney will be used to compare parametric continue variables.
By the utilization of Kaplan Meyer and log rank, survival curves of the two groups will be presented at the end of the study. A p-value of 5% or lower will be considered to be statistically significant
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unplanned Peritoneal Dialysis | – | –CKD patients stage 5 (eGFR < 15 ml/min/1,73m²) or stages 4 with abrupt worsening renal function requiring dialysis treatment immediately, followed or not by nephrologists prior to renal replacement therapy (RRT) indication, that agree to initiate peritoneal dialysis (PD) in less than 48 hours after implantation of the peritoneal catheter, without family training or adequacy of the home. The patient must not have any absolute contraindications to initiate PD, which include: presence of recent abdominal surgery (less than 30 days); multiple previous abdominal surgery (more than two); presence of fibrosis or peritoneal adhesions; fungal peritonitis; severe respiratory insufficiency (FiO2> 70%); abdominal infections; severe hyperkalemia with changes characteristic in ECG; and acute pulmonary edema. These patients will be treated with HD. |
| Unplanned Hemodialysis | – | –CKD patients stage 5 (eGFR < 15 ml/min/1,73m²) or stages 4 with abrupt worsening renal function requiring dialysis treatment immediately, followed or not by nephrologists prior to renal replacement therapy (RRT) indication, that agree to initiate HD without a functional arteriovenous fistula, ie, with a central venous catheter (nontunneled or tunneled). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Incident dialysis patients.
Key inclusion criteria (1 listed)
- Ambulatorial Chronic Kidney Disease patients stage 5 (eGFR < 15 ml/min) or stages 4 with abrupt worsening requiring dialysis treatment immediately followed or not by nephrologists prior to Renal Replacement Therapy indication.
Key exclusion criteria (4 listed)
- Transitions between HD and PD
- Patients with functional arteriovenous fistula entering hemodialysis
- Patients with functional PD access implanted ate least 48h before the first use
- Patient or family trained in PD and/or with the right adequacy of the home
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cost effectiveness analysis of unplanned PD and HD at the General Hospital of the School of Medicine of Botucatu (HC-FMB)
Time frame: 12 months
Cost effectiveness analysis of unplanned PD and HD with the data collected at our center
1 secondary outcome
Cost effectiveness analysis of unplanned PD and HD in national and international scenario
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Background: PubMed 22543907Woo KT, Choong HL, Wong KS, Tan HB, Chan CM. The contribution of chronic kidney disease to the global burden of major noncommunicable diseases. Kidney Int. 2012 May;81(10):1044-1045. doi: 10.1038/ki.2012.39. No abstract available.
- Background: PubMed 21422925Eggers PW. Has the incidence of end-stage renal disease in the USA and other countries stabilized? Curr Opin Nephrol Hypertens. 2011 May;20(3):241-5. doi: 10.1097/MNH.0b013e3283454319.
- Background: PubMed 25157840Klarenbach SW, Tonelli M, Chui B, Manns BJ. Economic evaluation of dialysis therapies. Nat Rev Nephrol. 2014 Nov;10(11):644-52. doi: 10.1038/nrneph.2014.145. Epub 2014 Aug 26.
- Background: PubMed 21310740Haller M, Gutjahr G, Kramar R, Harnoncourt F, Oberbauer R. Cost-effectiveness analysis of renal replacement therapy in Austria. Nephrol Dial Transplant. 2011 Sep;26(9):2988-95. doi: 10.1093/ndt/gfq780. Epub 2011 Feb 10.
- Background: PubMed 19207859Howard K, Salkeld G, White S, McDonald S, Chadban S, Craig JC, Cass A. The cost-effectiveness of increasing kidney transplantation and home-based dialysis. Nephrology (Carlton). 2009 Feb;14(1):123-32. doi: 10.1111/j.1440-1797.2008.01073.x.
- Background: PubMed 14633146Korevaar JC, Feith GW, Dekker FW, van Manen JG, Boeschoten EW, Bossuyt PM, Krediet RT; NECOSAD Study Group. Effect of starting with hemodialysis compared with peritoneal dialysis in patients new on dialysis treatment: a randomized controlled trial. Kidney Int. 2003 Dec;64(6):2222-8. doi: 10.1046/j.1523-1755.2003.00321.x.
- Background: PubMed 17080109Vonesh EF, Snyder JJ, Foley RN, Collins AJ. Mortality studies comparing peritoneal dialysis and hemodialysis: what do they tell us? Kidney Int Suppl. 2006 Nov;(103):S3-11. doi: 10.1038/sj.ki.5001910.
- Background: PubMed 21511830Perl J, Wald R, McFarlane P, Bargman JM, Vonesh E, Na Y, Jassal SV, Moist L. Hemodialysis vascular access modifies the association between dialysis modality and survival. J Am Soc Nephrol. 2011 Jun;22(6):1113-21. doi: 10.1681/ASN.2010111155. Epub 2011 Apr 21.
- Background: PubMed 11773473Heaf JG, Lokkegaard H, Madsen M. Initial survival advantage of peritoneal dialysis relative to haemodialysis. Nephrol Dial Transplant. 2002 Jan;17(1):112-7. doi: 10.1093/ndt/17.1.112.
- Background: PubMed 14569095Termorshuizen F, Korevaar JC, Dekker FW, Van Manen JG, Boeschoten EW, Krediet RT; Netherlands Cooperative Study on the Adequacy of Dialysis Study Group. Hemodialysis and peritoneal dialysis: comparison of adjusted mortality rates according to the duration of dialysis: analysis of The Netherlands Cooperative Study on the Adequacy of Dialysis 2. J Am Soc Nephrol. 2003 Nov;14(11):2851-60. doi: 10.1097/01.asn.0000091585.45723.9e.
- Background: PubMed 26897038Dias DB, Banin V, Mendes ML, Barretti P, Ponce D. Peritoneal dialysis can be an option for unplanned chronic dialysis: initial results from a developing country. Int Urol Nephrol. 2016 Jun;48(6):901-6. doi: 10.1007/s11255-016-1243-x. Epub 2016 Feb 20.
- Background: PubMed 23944971Silva TN, de Marchi D, Mendes ML, Barretti P, Ponce D. Approach to prophylactic measures for central venous catheter-related infections in hemodialysis: a critical review. Hemodial Int. 2014 Jan;18(1):15-23. doi: 10.1111/hdi.12071. Epub 2013 Aug 14.
- National Kidney Foundation. 2016Link provided by the sponsor.
- Danish Nephrology Registry, Annual Report 2011Link provided by the sponsor.
- Census of the Brazillian Society of Nephrology 2014Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cost-effectiveness Analysis and Chronic Kidney Disease Requiring Chronic Dialysis, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
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 1 inclusion and 4 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 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
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?
Cost effectiveness analysis of unplanned PD and HD at the General Hospital of the School of Medicine of Botucatu (HC-FMB) (time frame: 12 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 NCT03474367, which also lists 25 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 2 Oct 2019.