The Impact of Pharmaceutical Care on the Infection Control Measures Among Hemodialytic Patients

NCT ID: NCT06968754

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-05-15

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.

Conditions

Infection; Hemodialysis Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Non-Intervention group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Group

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.

Group Type: EXPERIMENTAL

Intervention Group

Intervention Type: OTHER

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.

Interventions

Intervention Group

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.

Intervention Type: OTHER

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sulaimani

OTHER

Sponsor Role: lead

Responsible Party

Kawa Ahmad Obeid

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shar Hospital

Sulaymaniyah, Sulaymaniyah Governorate, Iraq

Countries

Iraq

Other Identifiers

PH 140-24

Identifier Type: -

Identifier Source: org_study_id