Clinical trial NCT06968754: The Impact of Pharmaceutical Care on the Infection Control Measures Among Hemodialytic Patients
Official title: The Impact of Pharmaceutical Care on the Infection Control Measures Among Hemodialytic Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Infection
Hemodialysis Patients
Keywords: Pharmaceutical Care
Infection
hemodialysis
Staphylococcus aureus
Lead sponsor: University of Sulaimani
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Patients in dialysis center with CKD
* Patients that can communicate with the researcher.

Exclusion Criteria:

* The patients who are not willing to participate in this study are going to be excluded.

Primary outcomes:
measure: Infection Parameters
timeFrame: From enrollment to about 6 months
Secondary outcomes:
measure: Hospital admission rate
timeFrame: From enrollment to about 6 months
Other outcomes:
Locations:
city: Sulaymaniyah
country: Iraq
facility: Shar Hospital
state: Sulaymaniyah Governorate
Study officials:
References: