Clinical trial NCT05705895: The Efficiency of the Central Venous Catheter Care Protocol
Official title: Evaluation of the Efficiency of the Central Venous Catheter Care Protocol for Patients With Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stem Cell Transplant Complications
Central Venous Catheter Exit Site Infection
Keywords: Central Venous Catheter
Hematopoietic Stem Cell Transplantation
Lead sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Descriptive Information Form
timeFrame: Baseline
measure: Daily Patient Evaluation Chart
timeFrame: During the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Health Science University Gülhane Training and Research Hospital
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Canan PORUCU, MsN, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Callister D, Limchaiyawat P, Eells SJ, Miller LG. Risk factors for central line-associated bloodstream infections in the era of prevention bundles. Infect Control Hosp Epidemiol. 2015 Feb;36(2):214-6. doi: 10.1017/ice.2014.32.
citation: Demiraslan H, Cevahir F, Berk E, Metan G, Cetin M, Alp E. Is surveillance for colonization of carbapenem-resistant gram-negative bacteria important in adult bone marrow transplantation units? Am J Infect Control. 2017 Jul 1;45(7):735-739. doi: 10.1016/j.ajic.2017.01.006. Epub 2017 Feb 15.
citation: Ferroni A, Gaudin F, Guiffant G, Flaud P, Durussel JJ, Descamps P, Berche P, Nassif X, Merckx J. Pulsative flushing as a strategy to prevent bacterial colonization of vascular access devices. Med Devices (Auckl). 2014 Nov 7;7:379-83. doi: 10.2147/MDER.S71217. eCollection 2014.
citation: Gunasegaran N, See MTA, Leong ST, Yuan LX, Ang SY. A Randomized Controlled Study to Evaluate the Effectiveness of 2 Treatment Methods in Reducing Incidence of Short Peripheral Catheter-Related Phlebitis. J Infus Nurs. 2018 Mar/Apr;41(2):131-137. doi: 10.1097/NAN.0000000000000271.
citation: Flint AC, Toossi S, Chan SL, Rao VA, Sheridan W. A Simple Infection Control Protocol Durably Reduces External Ventricular Drain Infections to Near-Zero Levels. World Neurosurg. 2017 Mar;99:518-523. doi: 10.1016/j.wneu.2016.12.042. Epub 2016 Dec 22.