Complication of HemodialysisPhase 1/2NCT02263196
The Efficacy of Alcohol After Betadine and Combination of Alcohol and Betadine on Inflammation Vascular Access
A Phase 1/2 study testing Alcohol and povidone iodine and combination of alcohol and betadin in people with Complication of Hemodialysis, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study was to compare the efficacy of combination of alcohol and povidone iodine 10% and Alcohol 70% after povidone iodine 10% on inflammation and infection related to vascular access area in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Complication of Hemodialysis
- What is being tested?
- Alcohol and povidone iodine and combination of alcohol and betadin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteIran
- Study dates
- Sep 2014to May 2015
- Phase
- Phase 1/2
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- absence of inflammatory vascular access site
- three dialysis sessions per week
Who cannot join
- patient dies
- patient withdrew from the partnership
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Ali Bazzi
Mashhad
maryam bagheri, instructor, 09153031112, bagherim@mums.ac.ir
About this study
Official title: Mashhad University of Medical Sciences
The purpose of this study was to compare the efficacy of combination of alcohol and povidone iodine 10% and Alcohol 70% after povidone iodine 10% on inflammation and infection related to vascular access area in hemodialysis patients.
Read the detailed description
These cases were identified from patient that lack of specific diseases; Non-use of antibiotics or immunosuppressive drugs. That the participants will be selected using convenience sampling method and randomly divided into three groups: combination of alcohol and povidone iodine 10%, Alcohol after and control groups. In the Intervention in one group the vascular access site disinfected with Alcohol(group1) and in group 2, Alcohol and povidone iodine 10% was used to separate were disinfected. Then the patient in a month of inflammation and infection of the vascular access will be monitor. Exclusion criteria: inflammation or fistula failure during the study for any reason other than infection. Sample size determination: Through the pilot study. Date: 02.10.2014 till 02.11.2014 Outcome: Washing with both solution affected on reduce the inflammation and infection of the patient.
the efficacy of Alcohol after Betadine and combination of alcohol and Betadine on inflammation and infection related to Vascular access hemodialysis patients.
- Conditions
- Complication of Hemodialysis
- Being tested
- Alcohol and povidone iodine, combination of alcohol and betadin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol and povidone iodineOther
using from Alcohol and povidone iodine for prevention of inflammation
combination of alcohol and betadinOther
using from combination Alcohol and povidone iodine for prevention of inflammation
| Study group | Role | What they receive |
|---|---|---|
| alcohol and povidone iodine | Experimental | the efficacy of combination of alcohol and povidone iodine on inflammation related to vascular access Receives: Other: Alcohol and povidone iodine |
| combination of alcohol and betadin | Experimental | the efficacy of combination of alcohol and povidone iodine on infection related to vascular access Receives: Other: combination of alcohol and betadin |
What is being measured
The primary outcome is the main question the study is designed to answer.
effected of betadin and alcohol on inflammation and infection of the patient
Measured: up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complication of HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rajabpoor, Mashhad University of Medical Sciences
- Investigators
- mohmmad rajabpoor, student, Principal investigator, Msc Student, Faculty of Nursing and Midwifery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263196
- Sponsor's protocol ID
- 921839
- Status last verified
- Apr 2015
- First submitted
- 26 Sep 2014
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Branas P, Morales E, Rios F, Sanz F, Gutierrez E, Quintanilla N, Orellana MA, Sanchez M, Rodriguez-Aranda A, Chaves F. Usefulness of endoluminal catheter colonization surveillance cultures to reduce catheter-related bloodstream infections in hemodialysis. Am J Infect Control. 2014 Nov;42(11):1182-7. doi: 10.1016/j.ajic.2014.07.022. Epub 2014 Sep 22.
PubMed 25248485
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mashhad University of Medical Sciences
- ClinicalTrials.gov ID
- NCT02263196
- Acronym / sponsor ID
- 921839
- Conditions
- Complication of Hemodialysis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 13 Oct 2014 (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.
The purpose of this study was to compare the efficacy of combination of alcohol and povidone iodine 10% and Alcohol 70% after povidone iodine 10% on inflammation and infection related to vascular access area in hemodialysis patients.
Detailed description
These cases were identified from patient that lack of specific diseases; Non-use of antibiotics or immunosuppressive drugs. That the participants will be selected using convenience sampling method and randomly divided into three groups: combination of alcohol and povidone iodine 10%, Alcohol after and control groups. In the Intervention in one group the vascular access site disinfected with Alcohol(group1) and in group 2, Alcohol and povidone iodine 10% was used to separate were disinfected. Then the patient in a month of inflammation and infection of the vascular access will be monitor. Exclusion criteria: inflammation or fistula failure during the study for any reason other than infection. Sample size determination: Through the pilot study. Date: 02.10.2014 till 02.11.2014 Outcome: Washing with both solution affected on reduce the inflammation and infection of the patient.
the efficacy of Alcohol after Betadine and combination of alcohol and Betadine on inflammation and infection related to Vascular access hemodialysis patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alcohol and povidone iodine | Experimental | Other: Alcohol and povidone iodinethe efficacy of combination of alcohol and povidone iodine on inflammation related to vascular access |
| combination of alcohol and betadin | Experimental | Other: combination of alcohol and betadinthe efficacy of combination of alcohol and povidone iodine on infection related to vascular access |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- absence of inflammatory vascular access site
- three dialysis sessions per week
Key exclusion criteria (2 listed)
- patient dies
- patient withdrew from the partnership
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 |
|---|---|---|
| Alcohol and povidone iodineusing from Alcohol and povidone iodine for prevention of inflammation | Other | alcohol and povidone iodine |
| combination of alcohol and betadinusing from combination Alcohol and povidone iodine for prevention of inflammation | Other | combination of alcohol and betadin |
Primary outcome
effected of betadin and alcohol on inflammation and infection of the patient
Time frame: up to one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
- Background: PubMed 25248485Branas P, Morales E, Rios F, Sanz F, Gutierrez E, Quintanilla N, Orellana MA, Sanchez M, Rodriguez-Aranda A, Chaves F. Usefulness of endoluminal catheter colonization surveillance cultures to reduce catheter-related bloodstream infections in hemodialysis. Am J Infect Control. 2014 Nov;42(11):1182-7. doi: 10.1016/j.ajic.2014.07.022. Epub 2014 Sep 22.
- that is a article from pubmedLink provided by the sponsor.
Related trials for Complication of Hemodialysis
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Not yet recruiting
Cycling During Dialysis: A Feasibility and Safety Study
Hemodialysis, Kidney Disease, End-Stage
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.
mohmmad rajabpoor, student principal investigator
Msc Student, Faculty of Nursing and Midwifery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Alcohol and povidone iodine and combination of alcohol and betadin in people with Complication of Hemodialysis, run by Mashhad University of Medical Sciences at 1 site in Iran.
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 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 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 Iran. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ali bazzi, MSc student (09113723582, bazzia911@mums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effected of betadin and alcohol on inflammation and infection of the patient (time frame: up to one month). 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 NCT02263196, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2015.