Stem Cell Transplant ComplicationsNCT05705895
The Efficiency of the Central Venous Catheter Care Protocol
A study testing CENTRAL VENOUS CATHETER CARE PROTOCOL in people with Stem Cell Transplant Complications and Central Venous Catheter Exit Site Infection, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stem Cell Transplant Complications, Central Venous Catheter Exit Site Infection
- What is being tested?
- CENTRAL VENOUS CATHETER CARE PROTOCOL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Health Science University Gülhane Training and Research Hospital
Ankara
Canan PORUCU, MsN, RN, 5344327559, cananyaranoglu@hotmail.com
About this study
Official title: Evaluation of the Efficiency of the Central Venous Catheter Care Protocol for Patients With Hematopoietic Stem Cell Transplantation
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.
Read the 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.
- Being tested
- CENTRAL VENOUS CATHETER CARE PROTOCOL
- Keywords
- Central Venous Catheter, Hematopoietic Stem Cell Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CENTRAL VENOUS CATHETER CARE PROTOCOLProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Catheter care is provided in line with the CVC care protocol developed by the researcher. Receives: Procedure: CENTRAL VENOUS CATHETER CARE PROTOCOL |
| Control Group | No intervention | No intervention will be made to the patients in the control group, and catheter care will be provided in line with the clinical routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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..
Measured: Baseline
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.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start1 Jan 2022
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Stem Cell Transplant ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Canan Yaranoglu, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Investigators
- Canan PORUCU, MsN, RN, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705895
- Sponsor's protocol ID
- 2021/51
- Status last verified
- Jan 2023
- First submitted
- 13 Jan 2023
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25633005Demiraslan 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.
PubMed 28214159Ferroni 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.
PubMed 25404862Gunasegaran 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.
PubMed 29489709Flint 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.
PubMed 28012890
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency of the Central Venous Catheter Care Protocol for Patients With Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT05705895
- Acronym / sponsor ID
- 2021/51
- Keywords
- Central Venous Catheter, Hematopoietic Stem Cell Transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Procedure: CENTRAL VENOUS CATHETER CARE PROTOCOLCatheter care is provided in line with the CVC care protocol developed by the researcher. |
| Control Group | No intervention | –No intervention will be made to the patients in the control group, and catheter care will be provided in line with the clinical routine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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,
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CENTRAL VENOUS CATHETER CARE PROTOCOLCatheter 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. | Procedure or surgery | Intervention Group |
Primary outcome
Patient Descriptive Information Form
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Background: PubMed 25633005Callister 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.
- Background: PubMed 28214159Demiraslan 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.
- Background: PubMed 25404862Ferroni 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.
- Background: PubMed 29489709Gunasegaran 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.
- Background: PubMed 28012890Flint 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Canan PORUCU, MsN, RN principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CENTRAL VENOUS CATHETER CARE PROTOCOL in people with Stem Cell Transplant Complications and Central Venous Catheter Exit Site Infection, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Canan PORUCU, MsN, RN (05344327559, cananyaranoglu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Descriptive Information Form (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05705895, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.