End Stage Renal Failure on DialysisHIPPO-SATNCT02002169
Hemodialysis Infection Prevention Using Polysporin Ointment With Shower Technique in Satellite Centres Pilot Study
A study testing Shower Technique Protocol and Standard CVC Care in people with End Stage Renal Failure on Dialysis, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Background: The investigators developed a Shower Technique protocol (STP) for hemodialysis (HD) patients with healed central venous catheter (CVC) exit sites, designed to permit showering but not increase infection risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Failure on Dialysis
- What is being tested?
- Shower Technique Protocol and Standard CVC Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2012to Nov 2014
- Phase
- Interventional
- 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
Who may be able to join
- Informed written consent obtained (English speaking)
- Age >18 years
- Requires a CVC as the vascular access: a) end stage kidney disease without a functioning surgically created access; b) end stage kidney disease whose peritoneal dialysis problems require transfer to HD for an anticipated prolonged period
- Passed 2/3 tests of CVC exit site healing (see below)
- Must be willing and able to take a shower as the standard form of body cleansing if randomized to STP
- Trisodium citrate (4%) as standard CVC locking solution
- CVC has been in situ for > 6 weeks
Who cannot join
- Acute kidney failure, likely to be reversible with recovery of renal function
- Non-Tunneled CVC
- Antibiotic use by any route in the week prior to enrolling in the study, including intranasal mupirocin
- On immunosuppressant therapy
- Use of the CVC for purposes other than access for hemodialysis
- Involvement in another interventional study related to their vascular access
Show all 9Show fewer
- CVC or patient life expectancy <6 months (e.g. active malignancy; serious comorbidity such as hepatic failure)
- Routine use of tissue plasminogen activator or antibiotic as a locking solution
- CVC insertion in location other than the neck/chest region (IJ or subclavian acceptable)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital
Toronto, Ontario, M4N 2C4
S Daisy Kosa, BHSc, (905) 745-4773, sarah.kosa@uhn.ca
Cathy Forrester, RN, (416) 340-4800 ext. 4806, cathy.forrester@uhn.ca
About this study
Official title: Hemodialysis Infection Prevention Using Polysporin Ointment With Shower Technique in Satellite Centres (HIPPO SAT) Pilot Study
Background: The investigators developed a Shower Technique protocol (STP) for hemodialysis (HD) patients with healed central venous catheter (CVC) exit sites, designed to permit showering but not increase infection risk.
Research question: Is it feasible to conduct a randomized control trial comparing the rate of CVC related bacteremia (CRB) in adult satellite HD patients using STP versus standard CVC care alone with 6 month follow up? Study Design: This pilot study is a multi-centre randomized control trial. Eligible participants will be randomized to STP versus standard care after meeting predefined criteria to confirm healed tunneled CVC exit site.
Read more
Primary Outcome: Feasibility will be determined based on 5 outcome measures: accuracy of the CRB rate documentation in the satellite setting, percentage of patients screened, recruited, educated successfully in the STP (intervention arm), and aspects of STP (% of contaminated patients in the control arm).
Study Setting: In satellite units affiliated with 2 academic and 3 community centres in south central Ontario, Canada.
Patient Population: Adult satellite HD patients dialyzing via CVC with healed CVC exit sites.
Intervention: STP and standard CVC care; or Control: standard CVC care; Analysis: Each measure of feasibility has its statistical threshold for success. If the threshold is reached in 4 of the 5 measures, the full HIPPO SAT study will be deemed feasible.
Discussion: A pilot feasibility study of the larger study is critical due to the potential challenges associated with recruitment, compliance and contamination.
Read the detailed description
CVC related infections are associated with increased morbidity and hospitalization rates, high treatment costs, and poor survival compared to use of an arteriovenous access. To prevent infection, patients should preserve the integrity and dryness of their CVC dressings. Showering should be avoided, as it is difficult to attain full protective coverage of the exit site using dressings and barriers. Wet dressings place patients at increased infection risk, especially if their CVC exit site is not fully healed. However, in a survey of 274 CVC dependent HD patients, 64% indicated that the recommended prohibition to shower was moderately to extremely inconvenient and reduced their quality of life. Additionally 77% of patients admitted to showering at least once while they had a CVC.
While submersion of the CVC in water is discouraged by clinical practice guidelines, they also state that if precautions can be taken to reduce the likelihood of bacterial CVC entry then showering may be acceptable. However, this guidance is opinion based with no evidence to support specific precautions. Thus, to address the patients' desire to shower safely, at least 2 separate dialysis facilities in Ontario, Canada have developed a showering procedure as an alternative method of CVC care. Preliminary data from a small proof-of-concept study of 65 patients suggests acceptable CRB rates (0.46/1000 CVC days) using such showering procedures. The study was conducted in satellite HD units on a select population of patients who were infection-free for 6 months using the same CVC. Satellite units offer dialysis in an outpatient setting for those patients who are stable and require less intensive care than in-centre patients. The satellite HD population is typically younger and healthier, and likely more able to perform showering procedures than in-centre patients. With increasing patients in satellite HD, it is crucial that a pragmatic, yet effective, prophylactic CVC infection strategy be formally tested and established for this setting.
Following the proof-of-concept study, nephrologists, vascular access coordinators, and HD centres from five dialysis centres across Ontario, collaborated to create a formal Shower Technique Protocol (STP) which includes chlorhexidine applicators after showering to minimize the risk of bacterial entry at the CVC exit site. STP is designed specifically for patients with a fully endothelialized CVC tunnel and healed exit site. Participants allocated to STP are able to shower and change their dressing up to 3 times per week. Prior to more widespread implementation of the STP, it is critical to determine whether it is safe for use in patients with healed CVC exit sites. In other words, to confirm that CRB rates in patients using STP are not greater than the CRB rates in patients using the gold standard of CVC care. It is unknown whether using the STP improves patient satisfaction with their CVC care.
- Conditions
- End Stage Renal Failure on Dialysis
- Being tested
- Shower Technique Protocol, Standard CVC Care
- Keywords
- Catheter Related Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shower Technique ProtocolOther
Video and educational pamphlets of the STP will be used to assist in training participants randomized to this intervention. The participant must successfully demonstrate the STP on a training mannequin and be deemed by the study coordinator as ready to independently and correctly perform it before proceeding.
Standard CVC CareOther
Nuanced differences may be present at participating units; however, the key components of the intervention are 1) HD nurse delivery of CVC care 2) chlorhexidine or povidone cleansing 3) dry gauze dressing 4) standardized frequency. For both STP and control arms, participants whose HD centre uses polysporin triple ointment as part of standard CVC care will continue to have it applied as per program policy.
| Study group | Role | What they receive |
|---|---|---|
| Shower Technique Protocol (STP) | Experimental | Participants will be given a minimum 30 minute personalized educational session by the study coordinator. They will be taught safe and clean techniques for showering with their CVC. If the participant passes the Shower Technique Test, they will be provided a pamphlet on the STP, not to be shared with other participants, to be kept as a reference and placed in their bathroom/household. They will also be given the necessary supplies for the STP. Receives: Other: Shower Technique Protocol; Other: Standard CVC Care |
| Standard CVC care | Active comparator | Standard CVC Care consists of cleansing with chlorhexidine 2% or povidone (if allergic to chlorhexidine) at the CVC exit site by trained HD nurses followed by placement of a dry gauze dressing by the HD nurse 1x/week or when clinically indicated. In order to participate in the standard CVC care arm, participating sites must have in their policy that it is trained HD nurses who will apply the Polysporin Triple Ointment after standard cleansing with chlorhexidine 2% or povidone during HD, according to guideline recommendations or as per hospital patient care standards and nursing regulations. Receives: Other: Standard CVC Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Feasibility Measure of the HIPPO SAT trial: Defined by 5 outcomes
Outcome Measures of Feasibility
- The level of agreement between the date the nurse contacts the coordinator to inform them of a suspected infection and the date the culture was sent to the lab from the HD unit
- The percentage of eligible patients who consent to participate in each participating satellite unit
- The percentage of satellite HD patients with CVCs who are screened for eligibility
- The percentage of patients in the Shower Technique arm passing the shower technique test at 3 and 6 months
- The percentage of patients in the control arm who are contaminated i.e. using aspects of the STP such as chlorhexidine swabs at home at the exit site which they were not using at baseline
Measured: 6 months
Secondary outcomes (2)
Secondary Feasibility Outcome: The change in Vascular Access Questionnaire (VAQ) score over time using the Shower Technique protocol compared to standard care.
The VAQ is a measure of patient satisfaction with their vascular access that is previously un validated in this population
Measured: 6 months
Secondary Feasibility Outcome: The level agreement between the Deep Breath and CVC Seal tests and the blinded photo test
Once written consent is obtained, the participant will undergo formal testing for CVC exit site healing. The tests of CVC exit site healing are as follows: 1) Deep Breath Stability Test measures the migration of the CVC as marked by a 2 cm indicator on the CVC from the skin at CVC exit. There should be < 3 mm movement between complete exhalation and inhalation; 2) CVC Seal Test is a visual inspection against an objective checklist to determine healing; and 3) Blinded Photo Test where two photos are taken of the CVC exit site to be evaluated for healing by independent blinded trained assessors. Both assessors must agree that the exit site is healed to pass the test.
Measured: After consent and prior to randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startDec 2012
- Primary completionJul 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Failure on DialysisStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Scarborough General Hospital, London Health Sciences Centre, Trillium Health Centre, York Central Hospital, Ontario
- Responsible party
- Sponsor
- Investigators
- Charmaine Lok, MD, MSc, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002169
- Sponsor's protocol ID
- REB 12-0404-AE
- Acronym
- HIPPO-SAT
- Status last verified
- Dec 2013
- First submitted
- 28 Nov 2013
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodialysis Infection Prevention Using Polysporin Ointment With Shower Technique in Satellite Centres (HIPPO SAT) Pilot Study
- ClinicalTrials.gov ID
- NCT02002169
- Acronym / sponsor ID
- HIPPO-SAT / REB 12-0404-AE
- Conditions
- End Stage Renal Failure on Dialysis
- Keywords
- Catheter Related Bacteremia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Scarborough General Hospital, London Health Sciences Centre, Trillium Health Centre, York Central Hospital, Ontario
- Study start
- Dec 2012
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 5 Dec 2013 (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.
Background: The investigators developed a Shower Technique protocol (STP) for hemodialysis (HD) patients with healed central venous catheter (CVC) exit sites, designed to permit showering but not increase infection risk.
Research question: Is it feasible to conduct a randomized control trial comparing the rate of CVC related bacteremia (CRB) in adult satellite HD patients using STP versus standard CVC care alone with 6 month follow up? Study Design: This pilot study is a multi-centre randomized control trial. Eligible participants will be randomized to STP versus standard care after meeting predefined criteria to confirm healed tunneled CVC exit site.
Primary Outcome: Feasibility will be determined based on 5 outcome measures: accuracy of the CRB rate documentation in the satellite setting, percentage of patients screened, recruited, educated successfully in the STP (intervention arm), and aspects of STP (% of contaminated patients in the control arm).
Study Setting: In satellite units affiliated with 2 academic and 3 community centres in south central Ontario, Canada.
Patient Population: Adult satellite HD patients dialyzing via CVC with healed CVC exit sites.
Intervention: STP and standard CVC care; or Control: standard CVC care; Analysis: Each measure of feasibility has its statistical threshold for success. If the threshold is reached in 4 of the 5 measures, the full HIPPO SAT study will be deemed feasible.
Discussion: A pilot feasibility study of the larger study is critical due to the potential challenges associated with recruitment, compliance and contamination.
Detailed description
CVC related infections are associated with increased morbidity and hospitalization rates, high treatment costs, and poor survival compared to use of an arteriovenous access. To prevent infection, patients should preserve the integrity and dryness of their CVC dressings. Showering should be avoided, as it is difficult to attain full protective coverage of the exit site using dressings and barriers. Wet dressings place patients at increased infection risk, especially if their CVC exit site is not fully healed. However, in a survey of 274 CVC dependent HD patients, 64% indicated that the recommended prohibition to shower was moderately to extremely inconvenient and reduced their quality of life. Additionally 77% of patients admitted to showering at least once while they had a CVC.
While submersion of the CVC in water is discouraged by clinical practice guidelines, they also state that if precautions can be taken to reduce the likelihood of bacterial CVC entry then showering may be acceptable. However, this guidance is opinion based with no evidence to support specific precautions. Thus, to address the patients' desire to shower safely, at least 2 separate dialysis facilities in Ontario, Canada have developed a showering procedure as an alternative method of CVC care. Preliminary data from a small proof-of-concept study of 65 patients suggests acceptable CRB rates (0.46/1000 CVC days) using such showering procedures. The study was conducted in satellite HD units on a select population of patients who were infection-free for 6 months using the same CVC. Satellite units offer dialysis in an outpatient setting for those patients who are stable and require less intensive care than in-centre patients. The satellite HD population is typically younger and healthier, and likely more able to perform showering procedures than in-centre patients. With increasing patients in satellite HD, it is crucial that a pragmatic, yet effective, prophylactic CVC infection strategy be formally tested and established for this setting.
Following the proof-of-concept study, nephrologists, vascular access coordinators, and HD centres from five dialysis centres across Ontario, collaborated to create a formal Shower Technique Protocol (STP) which includes chlorhexidine applicators after showering to minimize the risk of bacterial entry at the CVC exit site. STP is designed specifically for patients with a fully endothelialized CVC tunnel and healed exit site. Participants allocated to STP are able to shower and change their dressing up to 3 times per week. Prior to more widespread implementation of the STP, it is critical to determine whether it is safe for use in patients with healed CVC exit sites. In other words, to confirm that CRB rates in patients using STP are not greater than the CRB rates in patients using the gold standard of CVC care. It is unknown whether using the STP improves patient satisfaction with their CVC care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shower Technique Protocol (STP) | Experimental | Other: Shower Technique Protocol, Other: Standard CVC CareParticipants will be given a minimum 30 minute personalized educational session by the study coordinator. They will be taught safe and clean techniques for showering with their CVC. If the participant passes the Shower Technique Test, they will be provided a pamphlet on the STP, not to be shared with other participants, to be kept as a reference and placed in their bathroom/household. They will also be given the necessary supplies for the STP. |
| Standard CVC care | Active comparator | Other: Standard CVC CareStandard CVC Care consists of cleansing with chlorhexidine 2% or povidone (if allergic to chlorhexidine) at the CVC exit site by trained HD nurses followed by placement of a dry gauze dressing by the HD nurse 1x/week or when clinically indicated. In order to participate in the standard CVC care arm, participating sites must have in their policy that it is trained HD nurses who will apply the Polysporin Triple Ointment after standard cleansing with chlorhexidine 2% or povidone during HD, according to guideline recommendations or as per hospital patient care standards and nursing regulations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed written consent obtained (English speaking)
- Age >18 years
- Requires a CVC as the vascular access: a) end stage kidney disease without a functioning surgically created access; b) end stage kidney disease whose peritoneal dialysis problems require transfer to HD for an anticipated prolonged period
- Passed 2/3 tests of CVC exit site healing (see below)
- Must be willing and able to take a shower as the standard form of body cleansing if randomized to STP
Key exclusion criteria (9 listed)
- Acute kidney failure, likely to be reversible with recovery of renal function
- Non-Tunneled CVC
- Antibiotic use by any route in the week prior to enrolling in the study, including intranasal mupirocin
- On immunosuppressant therapy
- Use of the CVC for purposes other than access for hemodialysis
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 |
|---|---|---|
| Shower Technique ProtocolVideo and educational pamphlets of the STP will be used to assist in training participants randomized to this intervention. The participant must successfully demonstrate the STP on a training mannequin and be deemed by the study coordinator as ready to independently and correctly perform it before proceeding. | Other | Shower Technique Protocol (STP) |
| Standard CVC CareNuanced differences may be present at participating units; however, the key components of the intervention are 1) HD nurse delivery of CVC care 2) chlorhexidine or povidone cleansing 3) dry gauze dressing 4) standardized frequency. For both STP and control arms, participants whose HD centre uses polysporin triple ointment as part of standard CVC care will continue to have it applied as per program policy. | Other | Shower Technique Protocol (STP), Standard CVC care |
Primary outcome
Primary Feasibility Measure of the HIPPO SAT trial: Defined by 5 outcomes
Time frame: 6 months
Outcome Measures of Feasibility 1. The level of agreement between the date the nurse contacts the coordinator to inform them of a suspected infection and the date the culture was sent to the lab from the HD unit 2. The percentage of eligible patients who consent to participate in each participating satellite unit 3. The percentage of satellite HD patients with CVCs who are screened for eligibility 4. The percentage of patients in the Shower Technique arm passing the shower technique test at 3 and 6 months 5. The percentage of patients in the control arm who are contaminated i.e. using aspects of the STP such as chlorhexidine swabs at home at the exit site which they were not using at baseline
2 secondary outcomes
Secondary Feasibility Outcome: The change in Vascular Access Questionnaire (VAQ) score over time using the Shower Technique protocol compared to standard care.
Time frame: 6 months
Secondary Feasibility Outcome: The level agreement between the Deep Breath and CVC Seal tests and the blinded photo test
Time frame: After consent and prior to randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2013.
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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.
Charmaine Lok, MD, MSc principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shower Technique Protocol and Standard CVC Care in people with End Stage Renal Failure on Dialysis, run by University Health Network, Toronto at 1 site in Canada.
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 7 inclusion and 9 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 10 Dec 2013. 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 Canada. 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 Daisy Kosa, MSc. (c) ((905) 745-4773, sarah.kosa@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Feasibility Measure of the HIPPO SAT trial: Defined by 5 outcomes (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2013.