InfectionNCT06968754
The Impact of Pharmaceutical Care on the Infection Control Measures Among Hemodialytic Patients
A study testing Intervention Group in people with Infection and Hemodialysis Patients, run by University of Sulaimani at 1 site in Iraq.
Trial summary
The study aims to assess the effectiveness of pharmaceutical care in reducing infection rates among hemodialysis patients with central venous (CV) lines. It will evaluate the role of clinical pharmacists in optimizing infection management and antimicrobial use. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infection, Hemodialysis Patients
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIraq
- Study dates
- 1 Nov 2024to 15 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients in dialysis center with CKD
- Patients that can communicate with the researcher.
Who cannot join
- The patients who are not willing to participate in this study are going to be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to assess the effectiveness of pharmaceutical care in reducing infection rates among hemodialysis patients with central venous (CV) lines. It will evaluate the role of clinical pharmacists in optimizing infection management and antimicrobial use. Additionally, the study will examine the impact of pharmacist-led education on patient adherence to infection prevention and medication regimens. The role of pharmacists in reducing catheter-related bloodstream infections (CRBSIs) and other dialysis-related infections will also be investigated. Finally, the study will evaluate patient satisfaction and quality of life improvements resulting from pharmaceutical interventions in infection management.
Read the detailed description
This interventional randomized controlled trial aims to investigate the impact of clinical pharmacist intervention on infection control measures among hemodialysis patients. A total of 70 patients will be randomly assigned to either an intervention group (35 patients) or a non-intervention (control) group (35 patients), and the study will be conducted over a period of six months. Patients in the intervention group will receive pharmaceutical care in addition to standard care, with the clinical pharmacist identifying and resolving drug therapy problems (DTPs) related to indication, effectiveness, safety, and compliance. Specific infection control strategies in this group will include early referral to a nephrologist and patient education to reduce catheter use, thereby promoting timely transition to permanent vascular access options such as arteriovenous fistulas or grafts. In addition, topical antimicrobial ointments (e.g., Polysporin triple antibiotic ointment, Mupirocin, or medicinal honey) will be recommended for application at the catheter exit site during insertion and at each dialysis session to reduce catheter-related bloodstream infections. Antiseptic lock solutions will be used to prevent catheter colonization and biofilm formation, while prophylactic antibiotic-anticoagulant lock solutions will be applied to further reduce bloodstream infection risk. The pharmacist will also ensure appropriate selection and monitoring of antimicrobial agents based on culture sensitivity results. Meanwhile, patients in the non-intervention group will receive only conventional healthcare, with the researcher following them regularly to assess infection rates and identify any DTPs without intervening. For both groups, regular monitoring will include laboratory tests such as CBC, C-reactive protein (CRP) plasma viscosity, blood culture, and serum creatinine.
- Conditions
- Infection, Hemodialysis Patients
- Being tested
- Intervention Group
- Keywords
- Pharmaceutical Care, Infection, hemodialysis, Staphylococcus aureus
- Medical subject headings
- Infections, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupOther
Pharmaceutical care will be provided by a clinical pharmacist in addition to conventional care. This includes assessment and resolution of drug therapy problems (DTPs) related to indication, effectiveness, safety, and compliance. Infection control interventions involve: patient education for early AV fistula use, topical antimicrobials at the catheter exit site (e.g., Mupirocin), antiseptic/antibiotic lock solutions to prevent bloodstream infections, and antimicrobial selection based on culture sensitivity. Patients will receive ongoing follow-up and support throughout the study period.
| Study group | Role | What they receive |
|---|---|---|
| Non-Intervention group | No intervention | Not described |
| Intervention Group | Experimental | Pharmaceutical care will be provided by a clinical pharmacist in addition to conventional care. This includes assessment and resolution of drug therapy problems (DTPs) related to indication, effectiveness, safety, and compliance. Infection control interventions involve: patient education for early AV fistula use, topical antimicrobials at the catheter exit site (e.g., Mupirocin), antiseptic/antibiotic lock solutions to prevent bloodstream infections, and antimicrobial selection based on culture sensitivity. Patients will receive ongoing follow-up and support throughout the study period. Receives: Other: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection Parameters
This study measures several clinical outcomes related to catheter use in hemodialysis patients. The primary outcome is the rate of catheter-related infections, identified based on clinical symptoms (such as fever or local inflammation) and confirmed by laboratory culture.
Measured: From enrollment to about 6 months
Secondary outcomes (1)
Hospital admission rate
Secondary outcomes include the hospital admission rate for any cause, ICU admission rate due to clinical deterioration (particularly from catheter-related sepsis), and the total length of hospital stay in days, including both ward and ICU durations. Additionally, all-cause mortality is recorded, capturing deaths from infection, dialysis-related complications, or other comorbidities. Data for all outcomes are obtained from hospital medical records and, when necessary, national death registries. These measures provide a comprehensive view of the clinical impact of the intervention and are used to compare the intervention and non-intervention groups over the study period.
Measured: From enrollment to about 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Nov 2024
- Primary completion15 May 2025 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sulaimani
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kawa Ahmad Obeid, University of Sulaimani
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968754
- Sponsor's protocol ID
- PH 140-24
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Pharmaceutical Care on the Infection Control Measures Among Hemodialytic Patients
- ClinicalTrials.gov ID
- NCT06968754
- Acronym / sponsor ID
- PH 140-24
- Conditions
- Infection, Hemodialysis Patients
- Keywords
- Pharmaceutical Care, Infection, hemodialysis, Staphylococcus aureus
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of SulaimaniUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 13 May 2025 (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.
The study aims to assess the effectiveness of pharmaceutical care in reducing infection rates among hemodialysis patients with central venous (CV) lines. It will evaluate the role of clinical pharmacists in optimizing infection management and antimicrobial use. Additionally, the study will examine the impact of pharmacist-led education on patient adherence to infection prevention and medication regimens. The role of pharmacists in reducing catheter-related bloodstream infections (CRBSIs) and other dialysis-related infections will also be investigated. Finally, the study will evaluate patient satisfaction and quality of life improvements resulting from pharmaceutical interventions in infection management.
Detailed description
This interventional randomized controlled trial aims to investigate the impact of clinical pharmacist intervention on infection control measures among hemodialysis patients. A total of 70 patients will be randomly assigned to either an intervention group (35 patients) or a non-intervention (control) group (35 patients), and the study will be conducted over a period of six months. Patients in the intervention group will receive pharmaceutical care in addition to standard care, with the clinical pharmacist identifying and resolving drug therapy problems (DTPs) related to indication, effectiveness, safety, and compliance. Specific infection control strategies in this group will include early referral to a nephrologist and patient education to reduce catheter use, thereby promoting timely transition to permanent vascular access options such as arteriovenous fistulas or grafts. In addition, topical antimicrobial ointments (e.g., Polysporin triple antibiotic ointment, Mupirocin, or medicinal honey) will be recommended for application at the catheter exit site during insertion and at each dialysis session to reduce catheter-related bloodstream infections. Antiseptic lock solutions will be used to prevent catheter colonization and biofilm formation, while prophylactic antibiotic-anticoagulant lock solutions will be applied to further reduce bloodstream infection risk. The pharmacist will also ensure appropriate selection and monitoring of antimicrobial agents based on culture sensitivity results. Meanwhile, patients in the non-intervention group will receive only conventional healthcare, with the researcher following them regularly to assess infection rates and identify any DTPs without intervening. For both groups, regular monitoring will include laboratory tests such as CBC, C-reactive protein (CRP) plasma viscosity, blood culture, and serum creatinine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Intervention group | No intervention | – |
| Intervention Group | Experimental | Other: Intervention GroupPharmaceutical care will be provided by a clinical pharmacist in addition to conventional care. This includes assessment and resolution of drug therapy problems (DTPs) related to indication, effectiveness, safety, and compliance. Infection control interventions involve: patient education for early AV fistula use, topical antimicrobials at the catheter exit site (e.g., Mupirocin), antiseptic/antibiotic lock solutions to prevent bloodstream infections, and antimicrobial selection based on culture sensitivity. Patients will receive ongoing follow-up and support throughout the study period. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients in dialysis center with CKD
- Patients that can communicate with the researcher.
Key exclusion criteria (1 listed)
- The patients who are not willing to participate in this study are going to be excluded.
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 |
|---|---|---|
| Intervention GroupPharmaceutical care will be provided by a clinical pharmacist in addition to conventional care. This includes assessment and resolution of drug therapy problems (DTPs) related to indication, effectiveness, safety, and compliance. Infection control interventions involve: patient education for early AV fistula use, topical antimicrobials at the catheter exit site (e.g., Mupirocin), antiseptic/antibiotic lock solutions to prevent bloodstream infections, and antimicrobial selection based on culture sensitivity. Patients will receive ongoing follow-up and support throughout the study period. | Other | Intervention Group |
Primary outcome
Infection Parameters
Time frame: From enrollment to about 6 months
This study measures several clinical outcomes related to catheter use in hemodialysis patients. The primary outcome is the rate of catheter-related infections, identified based on clinical symptoms (such as fever or local inflammation) and confirmed by laboratory culture.
1 secondary outcome
Hospital admission rate
Time frame: From enrollment to about 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- 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?
A study testing Intervention Group in people with Infection and Hemodialysis Patients, run by University of Sulaimani at 1 site in Iraq.
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: under way, not looking for participants, as of the sponsor's last update on 13 May 2025. 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 Iraq. 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?
This study is still under way. Results are not available in the source record yet.
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?
Infection Parameters (time frame: From enrollment to about 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 13 May 2025.