Hemodialysis Catheter Infection
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEGroup 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.
OTHERGroup 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.
Sponsors
Hospital Universitario Marqués de Valdecilla
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be included in the haemodialysis programme in our unit. * Being a carrier of a tunneled central venous catheter as vascular access. * Remain on haemodialysis treatment for at least 3 months in our unit. * Consent to participate in the study.
Exclusion criteria
* Allergy or hypersensitivity to chlorhexidine or intolerance to polyurethane dressing * Active catheter-related infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bacteraemia Rate | 3 months | presence of fever (body temperature ≥38°C) together with a positive blood culture , with no other source of infection. |
| Exit Site Infection Rate | 3 months | 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. |
| Tunnelitis Rate | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Rate | 3 months | 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. |
| Percentage of Hemodialysis Sessions With Skin Lesions | 3 months | 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. |
| Percentage of Hemodialysis Sessions With Dressing-related Skin Erythema Rate | 3 months | 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. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group Solution Clinical characteristics of the solution group | 25 |
| Group Chlorhexidine Dressing Clinical characteristics of the chlorhexidine dressing group | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
Baseline characteristics
| Characteristic | Group Solution | Group Chlorhexidine Dressing | Total |
|---|---|---|---|
| Age, Continuous | 70 years STANDARD_DEVIATION 13 | 68 years STANDARD_DEVIATION 15 | 69 years STANDARD_DEVIATION 15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants | 25 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Spain | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 11 Participants | 12 Participants | 23 Participants |
| Sex: Female, Male Male | 14 Participants | 13 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Bacteraemia Rate
presence of fever (body temperature ≥38°C) together with a positive blood culture , with no other source of infection.
Time frame: 3 months
Population: Patients with tunneled central venous catheter for hemodialysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Arm Group Solution | Bacteraemia Rate | 2 episodes |
| Experimental Arm Chlorhexidine Dressing | Bacteraemia Rate | 1 episodes |
p-value: 195% CI: [0.048, 5.892]t-test, 1 sided
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.
Time frame: 3 months
Population: patients with tunneled central venous catheters for hemodialysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Arm Group Solution | Exit Site Infection Rate | 2 episodes |
| Experimental Arm Chlorhexidine Dressing | Exit Site Infection Rate | 12 episodes |
p-value: 0.01395% CI: [0.039, 0.79]t-test, 1 sided
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.
Time frame: 3 months
Population: patients with tunneled central venous catheters for hemodialysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Arm Group Solution | Tunnelitis Rate | 0 episodes |
| Experimental Arm Chlorhexidine Dressing | Tunnelitis Rate | 0 episodes |
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.
Time frame: 3 months
Population: Patients with tunneled central venous catheter for hemodialysis
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Arm Group Solution | Patient Satisfaction Rate | Somewhat satisfied | 0 Participants |
| Control Arm Group Solution | Patient Satisfaction Rate | Very satisfied | 10 Participants |
| Control Arm Group Solution | Patient Satisfaction Rate | Not at all satisfied | 0 Participants |
| Control Arm Group Solution | Patient Satisfaction Rate | Completely satisfied | 12 Participants |
| Control Arm Group Solution | Patient Satisfaction Rate | Moderately satisfied | 3 Participants |
| Experimental Arm Chlorhexidine Dressing | Patient Satisfaction Rate | Completely satisfied | 17 Participants |
| Experimental Arm Chlorhexidine Dressing | Patient Satisfaction Rate | Somewhat satisfied | 2 Participants |
| Experimental Arm Chlorhexidine Dressing | Patient Satisfaction Rate | Moderately satisfied | 1 Participants |
| Experimental Arm Chlorhexidine Dressing | Patient Satisfaction Rate | Very satisfied | 5 Participants |
| Experimental Arm Chlorhexidine Dressing | Patient Satisfaction Rate | Not at all satisfied | 0 Participants |
p-value: 0.137Chi-squared, Corrected
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.
Time frame: 3 months
Population: Hemodialysis sessions performed during the follow-up period are analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Arm Group Solution | Percentage of Hemodialysis Sessions With Dressing-related Skin Erythema Rate | Not Erythema | 98.2 percentage of sessions |
| Control Arm Group Solution | Percentage of Hemodialysis Sessions With Dressing-related Skin Erythema Rate | Erythema | 1.8 percentage of sessions |
| Experimental Arm Chlorhexidine Dressing | Percentage of Hemodialysis Sessions With Dressing-related Skin Erythema Rate | Not Erythema | 99.2 percentage of sessions |
| Experimental Arm Chlorhexidine Dressing | Percentage of Hemodialysis Sessions With Dressing-related Skin Erythema Rate | Erythema | 0.8 percentage of sessions |
p-value: 0.055Chi-squared, Corrected
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.
Time frame: 3 months
Population: Hemodialysis sessions performed during the follow-up period are analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Arm Group Solution | Percentage of Hemodialysis Sessions With Skin Lesions | Not Skin Lesions | 99.1 percentage of sessions |
| Control Arm Group Solution | Percentage of Hemodialysis Sessions With Skin Lesions | Skin Lesions | 0.9 percentage of sessions |
| Experimental Arm Chlorhexidine Dressing | Percentage of Hemodialysis Sessions With Skin Lesions | Not Skin Lesions | 99 percentage of sessions |
| Experimental Arm Chlorhexidine Dressing | Percentage of Hemodialysis Sessions With Skin Lesions | Skin Lesions | 1 percentage of sessions |
p-value: 0.764Chi-squared, Corrected