The Efficiency of the Central Venous Catheter Care Protocol

Stem Cell Transplant Complications Clinical Trial

Official title:

Evaluation of the Efficiency of the Central Venous Catheter Care Protocol for Patients With Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05705895
• Other study ID #: 2021/51
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2023
• Source: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
• Contact: Canan PORUCU, MsN, RN
• Phone: 05344327559
• Email: cananyaranoglu[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Central Venous Catheter Exit Site Infection
• Stem Cell Transplant Complications

Intervention

Procedure:
• CENTRAL VENOUS CATHETER CARE PROTOCOL
Catheter care is provided in line with the CVC care protocol developed by the researcher: For subsequent catheter care, a transparent sterile catheter cover impregnated with 2% chlorhexidine gluconate will be used. The entry point of the catheter will be wiped with a disposable sterile skin cleaning applicator containing 2% Chlorhexidine Gluconate and 70% Isopropyl Alcohol, which will be provided by the researchers, and wait for it to dry. Vein valve/needleless connector will be used. Effective manual disinfection of needle-free connectors (hubs) will be ensured before each intervention. Needle-free connectors will be replaced every 96 hours at the latest. If necessary, the catheter lumen will be washed with a disposable, positive-pressure sterile washing system containing 10 ccs 0.9% sodium chloride to be provided by the investigators. Pulsatile "give stop give stop" technique will be used in the washing process.

Locations

Country	Name	City	State
Turkey	Health Science University Gülhane Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Descriptive Information Form	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..	Baseline
Primary	Daily Patient Evaluation Chart	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.	During the procedure