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The objective of this study is to compare the rate of hemodialysis catheter-related infections according to the treatment regimen: chlorhexidine gluconate dressing or chlorhexidine solution.
Introduction: The use of CVC as a vascular access for haemodialysis is associated with increased morbidity and mortality (up to 10 times higher in a patient with a CVC compared to an arteriovenous fistula), contributing to poorer patient outcomes and increased haemodialysis-related costs.
Aim: To compare the rate of catheter-related infections (bacteraemia, exit site infection and tunelitis) between haemodialysis catheter exit site dressing with 2% chlorhexidine gluconate self-adhesive semi-permeable polyurethane dressings (AGCD); and dressing with 2% chlorhexidine solution and covered with self-adhesive semi-permeable polyurethane dressing (PD).
Methods: A randomized clinical trial will be conducted to compare the occurrence of local and systemic infections related to hemodialysis catheter. Two care groups will be formed in which AGCD and PD dressings will be used. In addition, other clinical variables, patient satisfaction and dressing-related skin alterations will also be analyzed.
Scientific relevance: Infectious complications related with hemodialysis catheter have an increased morbidity, mortality and incremented costs.
Key words: hemodialysis, Central Venous Catheters, Bacteremia, exit site infection, tunnel infection, chlorhexidine gluconate dressing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group "chlorhexidine dressing" | Experimental | CHG Chlorhexidine Gluconate dressing |
|
| Group "solution" | Other | 2% aqueous-based chlorhexidine solution and covering with a semi-permeable self-adhesive polyurethane dressing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group "chlorhexidine dressing" | Device | Cleaning of the exit site with physiological saline (0.9%), drying with sterile gauze, application of semi-permeable polyurethane dressing with self-adhesive 2% chlorhexidine gluconate, centring the chlorhexidine gluconate band well over the exit site. |
| Measure | Description | Time Frame |
|---|---|---|
| Bacteraemia Rate | presence of fever (body temperature ≥38°C) together with a positive blood culture , with no other source of infection. | 3 months |
| Exit Site Infection Rate | positive culture of pericatheter smear together with presence of inflammatory signs limited to 2 cm around the cutaneous exit site, without upper extension towards the catheter cuff. | 3 months |
| Tunnelitis Rate | occurrence of inflammatory signs extending beyond 2 cm from the cutaneous exit site and into the subcutaneous tract of the catheter (tunnelitis). It may or may not be associated with fever and bacteraemia, and may be accompanied by purulent exudate through the cutaneous exit site. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction Rate | SCALE 18: Degree of perception of positive expectations, of the NOC taxonomy will be used. It will be evaluated using a 5-point Likert-type scale where 1- Not at all satisfied, 2- Somewhat satisfied, 3- Moderately satisfied, 4- Very satisfied, 5- Completely satisfied. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raquel Pelayo Alonso | Santander | Cantabria | 39008 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30792802 | Background | Vanholder R, Canaud B, Fluck R, Jadoul M, Labriola L, Marti-Monros A, Tordoir J, Van Biesen W. Diagnosis, prevention and treatment of haemodialysis catheter-related bloodstream infections (CRBSI): a position statement of European Renal Best Practice (ERBP). NDT Plus. 2010 Jun;3(3):234-246. doi: 10.1093/ndtplus/sfq041. No abstract available. | |
| 26589425 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group "Chlorhexidine Dressing" | CHG Chlorhexidine Gluconate dressing Group "chlorhexidine dressing": Cleaning of the exit site with physiological saline (0.9%), drying with sterile gauze, application of semi-permeable polyurethane dressing with self-adhesive 2% chlorhexidine gluconate, centring the chlorhexidine gluconate band well over the exit site. |
| FG001 | Group "Solution" | 2% aqueous-based chlorhexidine solution and covering with a semi-permeable self-adhesive polyurethane dressing. Group "solution": Cleansing of the exit site with physiological saline (0.9%), drying with sterile gauze, disinfection with 2% aqueous-based chlorhexidine solution, environmental drying for 30 seconds and covering with a semi-permeable self-adhesive polyurethane dressing. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group "Solution" | Clinical characteristics of the "solution" group |
| BG001 | Group "Chlorhexidine Dressing" | Clinical characteristics of the "chlorhexidine dressing" group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bacteraemia Rate | presence of fever (body temperature ≥38°C) together with a positive blood culture , with no other source of infection. | Patients with tunneled central venous catheter for hemodialysis | Posted | Number | episodes | 3 months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group "Chlorhexidine Dressing" | CHG Chlorhexidine Gluconate dressing Group "chlorhexidine dressing": Cleaning of the exit site with physiological saline (0.9%), drying with sterile gauze, application of semi-permeable polyurethane dressing with self-adhesive 2% chlorhexidine gluconate, centring the chlorhexidine gluconate band well over the exit site. |
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The main limitation is the limited follow-up time
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raquel Pelayo Alonso, Head Nurse of Nephrology, RN | Marques de Valdecilla University Hospital | +34 649443488 | raquel.pelayo@scsalud.es |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2021 | Nov 30, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 20, 2021 | Nov 30, 2023 | ICF_001.pdf |
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Group A: Haemodialysis catheter exit site dressing with 2% chlorhexidine gluconate self-adhesive semi-permeable polyurethane dressings
Group B: Haemodialysis catheter exit site dressing with 2% chlorhexidine aqueous solution and covered with a dressing of self-adhesive semi-permeable polyurethane dressings.
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|
| Group "solution" | Other | Cleansing of the exit site with physiological saline (0.9%), drying with sterile gauze, disinfection with 2% aqueous-based chlorhexidine solution, environmental drying for 30 seconds and covering with a semi-permeable self-adhesive polyurethane dressing. |
|
| Percentage of Hemodialysis Sessions With Skin Lesions |
They will be assessed at each hemodialysis session, using the NOC taxonomy Skin lesions, by means of the SCALE 14: Degree of a negative or adverse condition or response. A 5-point Likert-type scale will be used, where 1-Severe, 2-Substantial, 3-Moderate, 4-Leve, 5- None. |
| 3 months |
| Percentage of Hemodialysis Sessions With Dressing-related Skin Erythema Rate | They will be assessed at each hemodialysis session, using the NOC taxonomy Erytema, by means of the SCALE 14: Degree of a negative or adverse condition or response. A 5-point Likert-type scale will be used, where 1-Severe, 2-Substantial, 3-Moderate, 4-Leve, 5- None. | 3 months |
| Wang K, Wang P, Liang X, Lu X, Liu Z. Epidemiology of haemodialysis catheter complications: a survey of 865 dialysis patients from 14 haemodialysis centres in Henan province in China. BMJ Open. 2015 Nov 20;5(11):e007136. doi: 10.1136/bmjopen-2014-007136. |
| 27516139 | Background | Righetti M, Palmieri N, Bracchi O, Prencipe M, Bruschetta E, Colombo F, Brenna I, Stefani F, Amar K, Scalia A, Conte F. Tegaderm CHG dressing significantly improves catheter-related infection rate in hemodialysis patients. J Vasc Access. 2016 Sep 21;17(5):417-422. doi: 10.5301/jva.5000596. Epub 2016 Aug 1. |
| 31096918 | Background | Wei L, Li Y, Li X, Bian L, Wen Z, Li M. Chlorhexidine-impregnated dressing for the prophylaxis of central venous catheter-related complications: a systematic review and meta-analysis. BMC Infect Dis. 2019 May 16;19(1):429. doi: 10.1186/s12879-019-4029-9. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Exit Site Infection Rate | positive culture of pericatheter smear together with presence of inflammatory signs limited to 2 cm around the cutaneous exit site, without upper extension towards the catheter cuff. | patients with tunneled central venous catheters for hemodialysis | Posted | Number | episodes | 3 months |
|
|
|
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| Primary | Tunnelitis Rate | occurrence of inflammatory signs extending beyond 2 cm from the cutaneous exit site and into the subcutaneous tract of the catheter (tunnelitis). It may or may not be associated with fever and bacteraemia, and may be accompanied by purulent exudate through the cutaneous exit site. | patients with tunneled central venous catheters for hemodialysis | Posted | Number | episodes | 3 months |
|
|
|
| Secondary | Patient Satisfaction Rate | SCALE 18: Degree of perception of positive expectations, of the NOC taxonomy will be used. It will be evaluated using a 5-point Likert-type scale where 1- Not at all satisfied, 2- Somewhat satisfied, 3- Moderately satisfied, 4- Very satisfied, 5- Completely satisfied. | Patients with tunneled central venous catheter for hemodialysis | Posted | Count of Participants | Participants | 3 months |
|
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|
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| Secondary | Percentage of Hemodialysis Sessions With Skin Lesions | They will be assessed at each hemodialysis session, using the NOC taxonomy Skin lesions, by means of the SCALE 14: Degree of a negative or adverse condition or response. A 5-point Likert-type scale will be used, where 1-Severe, 2-Substantial, 3-Moderate, 4-Leve, 5- None. | Hemodialysis sessions performed during the follow-up period are analyzed. | Posted | Number | percentage of sessions | 3 months | Hemodialysis sessions | Hemodialysis sessions |
|
|
|
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| Secondary | Percentage of Hemodialysis Sessions With Dressing-related Skin Erythema Rate | They will be assessed at each hemodialysis session, using the NOC taxonomy Erytema, by means of the SCALE 14: Degree of a negative or adverse condition or response. A 5-point Likert-type scale will be used, where 1-Severe, 2-Substantial, 3-Moderate, 4-Leve, 5- None. | Hemodialysis sessions performed during the follow-up period are analyzed. | Posted | Number | percentage of sessions | 3 months | Hemodialysis sessions | Hemodialysis sessions |
|
|
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| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Group "Solution" | 2% aqueous-based chlorhexidine solution and covering with a semi-permeable self-adhesive polyurethane dressing. Group "solution": Cleansing of the exit site with physiological saline (0.9%), drying with sterile gauze, disinfection with 2% aqueous-based chlorhexidine solution, environmental drying for 30 seconds and covering with a semi-permeable self-adhesive polyurethane dressing. | 0 | 25 | 0 | 25 | 0 | 25 |
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| Moderately satisfied |
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| Very satisfied |
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| Completely satisfied |
|