The Efficiency of the Central Venous Catheter Care Protocol

Not Applicable

Recruiting

• Conditions: Central Venous Catheter Exit Site Infection; Stem Cell Transplant Complications

• Registration Number: NCT05705895
• Lead Sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Brief Summary

The study aims to evaluate the effectiveness of a central venous catheter (CVC) care protocol, which was created using current guidelines, research results, and expert opinions, on developing CVC-related bloodstream infection in patients with hematopoietic stem cell transplantation (HSCT) until discharge.

Detailed Description

Hematopoietic stem cell transplantation (HSCT) is one of the important treatment approaches that prolongs survival in patients with hematological malignancies, immunodeficiency and some solid tumors. Despite advances in the treatment process, reasons such as recurrence of the underlying disease, organ toxicities and infectious complications adversely affect treatment success. Reasons such as high-dose chemotherapy, frequent blood sampling, stem cell reinfusion, and total parenteral nutrition applied to HSCT patients increase the need for central venous catheter insertion. Although these tools are often necessary and useful in the bone marrow transplantation process, they also bring mechanical, embolic, and infectious complications.

Central venous catheters (CVC) are one of the main applications of modern clinical treatment. Reasons such as high-dose chemotherapy, frequent blood sampling, stem cell reinfusion, and total parenteral nutrition applied to HSCT patients increase the need for central venous catheter insertion. Although these tools are often necessary and valuable in the bone marrow transplantation process, they also bring mechanical, embolic, and infectious complications. The study aims to evaluate the effectiveness of a central venous catheter (CVC) care protocol, created using current guidelines, research results, and expert opinions, on developing CVC-related bloodstream infection in patients with hematopoietic stem cell transplantation (HSCT) until discharge.

This research is a pretest-posttest quasi-experimental clinical study. It is conducted with 60 patients between January 2022 and December 2023. The data is collected with Patient Information Form and Daily Patient Evaluation Chart. No application will be made to 30 patients in the control group, and catheter care will be provided to the patients of the intervention group in line with the CVC Care Protocol created by the researchers.

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2023-01
• Study First Submitted: 2023-01-13
• Study First Submitted QC: 2023-01-27
• Last Update Submitted: 2023-01-27
• Study First Posted: 2023-01-31
• Last Update Posted: 2023-01-31
• Primary Completion: 2023-07-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Being hospitalized by the Medical Oncology Clinic at in a training and research hospital to become an Autologous HSCT,
• The patient has an 8F-size, two-lumen temporary CVC,
• Over 18 years of age
• There is no communication problem,
• Agreeing to participate in the research voluntarily after being informed about the study,

Exclusion Criteria

• Using a vascular access method other than an 8F size two-lumen temporary CVC in the patient,
• Refusal to participate in the research voluntarily after being informed about the study,
• Identification of a different focus of infection in the patient.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient Descriptive Information Form	Baseline	It was developed by the researchers by examining the literature; It contains information about the socio-demographic characteristics of the patients such as age, gender, marital status, educational status, and the planned chemotherapy protocol, previous treatments, and medical conditions such as chronic diseases. There are 8 questions in the first part of the form, which includes socio-demographic characteristics, and 12 questions in the second part, which includes information on medical status..
Daily Patient Evaluation Chart	During the procedure	It was developed by researchers by examining the literature; patients' vital signs (recording of signs of infection such as hypotension, tachycardia, high fever), height-weight measurement results, daily central venous catheter insertion site control results (evaluation findings such as exudate, swelling, redness, discharge, etc.) and routine clinical procedures from patients every day. This is the chart in which the results of whole blood, CRP, Procalcitonin, sedimentation count values and hemoculture routinely taken at every fever, urine culture and catheter tip culture taken during discharge will be recorded. It also includes the control of the protocol implementation steps.

Trial Locations

Locations (1)

Health Science University Gülhane Training and Research Hospital; 🇹🇷 Ankara, Turkey