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

NCT06968754 | Active Not Recruiting DMC

• 1 other identifier: PH 140-24
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection; Hemodialysis Patients

Keywords

Pharmaceutical Care; Infection; hemodialysis; Staphylococcus aureus

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to about 6 months

Secondary Outcomes (1)

• Hospital admission rate

  From enrollment to about 6 months

Study Arms (2)

Non-Intervention group

NO INTERVENTION

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.

Other: Intervention Group

Interventions

Intervention Group 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.

Intervention Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sulaimani: lead

Study Sites (1)

Shar Hospital

Sulaymaniyah, Sulaymaniyah Governorate, 46000, Iraq

Location

MeSH Terms

Conditions

Infections; Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: November 1, 2024
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

IR (1)