Catheter-related Infections, Cross Infection, Infection Due to Indwelling Urinary Catheter, Pneumonia, Ventilator-associated, Surgical Wound Infection
Conditions
Keywords
nosocomial infection, hospital acquired infection, chlorhexidine, pneumonia, ventilator-associated, catheter-related infections, urinary tract infections, catheter-related, surgical site infection
Brief summary
This prospective, randomized, controlled trial will compare the incidence of nosocomial infections (composite of primary bloodstream infections, catheter-associated urinary tract infections, ventilator-associated pneumonia, and surgical site infections) that occur in intensive care unit (ICU) patients bathed with 2% chlorhexidine solution versus patients who receive standard bathing (soap and water or non-medicated cloths).
Detailed description
Upon study enrollment, patients will be randomized to one of two study arms. Patients in study arm one will receive standard bathing (soap and water or non-medicated cloth) daily. Patients in study arm two will receive a 2% chlorhexidine bath on study day 1 and every 48 hours and a standard bath (soap and water or non-medicated cloths) on study day 2 and every 48 hours. Patients will be followed until ICU day 28 or discharged from the surgical ICU. Hypothesis: Compared to standard daily bathing, chlorhexidine-based bathing on ICU admission and every 48 hours will decrease the incidence of nosocomial infections.
Interventions
DRUGChlorhexidine gluconate
Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours
OTHERStandard bathing
The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily.
Sponsors
Texas Southern University
The Methodist Hospital Research Institute
Joshua Swan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Admission to the surgical intensive care unit at The Methodist Hospital (Houston, TX) * Anticipated surgical intensive care unit length of stay of 48 hours or more
Exclusion criteria
* Pregnancy * Age less than 18 years old * Braden score of less than 9 upon admission to the surgical intensive care unit * Known allergy to chlorhexidine gluconate * Active skin irritation upon admission to the surgical intensive care unit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Nosocomial Infection | Up to 28 days | Proportion of patients with one or more incident nosocomial infections. Primary Efficacy Endpoints\* (Composite of new nosocomial infection) * Primary Bloodstream Infection * Catheter Related Urinary Tract Infection * Ventilator-Associated Pneumonia\*\* * Surgical Site Infection (\*)Diagnosed using the Centers for Disease Control criteria for hospital acquired infections. Only infections that develop 48 hours or more after study enrollment will be counted as primary endpoints. (\*\*)Ventilator associated pneumonia is defined as pneumonia that developed after 48 hours of mechanical ventilation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Skin Irritation | up to 28 days | The incidence of new onset skin irritation will be recorded and graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03. |
| ICU Length of Stay in Days | up to 28 days | Number of days in the ICU after enrollment in study until first ICU discharge. |
| Number of Patients With In-hospital Mortality | up to 28 days or until first hospital discharge | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chlorhexidine Gluconate Bathing Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that.
Chlorhexidine gluconate: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours | 161 |
| Standard Bathing Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.
Standard bathing: The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily. | 164 |
| Total | 325 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Previously enrolled in this trial | 13 | 11 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Chlorhexidine Gluconate Bathing | Standard Bathing | Total |
|---|---|---|---|
| Age, Continuous | 59.4 years STANDARD_DEVIATION 15.9 | 60.2 years STANDARD_DEVIATION 16.5 | 59.8 years STANDARD_DEVIATION 16.2 |
| Sex: Female, Male Female | 63 Participants | 78 Participants | 141 Participants |
| Sex: Female, Male Male | 98 Participants | 86 Participants | 184 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 30 / 161 | 31 / 164 |
| serious Total, serious adverse events | 1 / 161 | 0 / 164 |
Outcome results
Primary
Incidence of Nosocomial Infection
Proportion of patients with one or more incident nosocomial infections. Primary Efficacy Endpoints\* (Composite of new nosocomial infection) * Primary Bloodstream Infection * Catheter Related Urinary Tract Infection * Ventilator-Associated Pneumonia\*\* * Surgical Site Infection (\*)Diagnosed using the Centers for Disease Control criteria for hospital acquired infections. Only infections that develop 48 hours or more after study enrollment will be counted as primary endpoints. (\*\*)Ventilator associated pneumonia is defined as pneumonia that developed after 48 hours of mechanical ventilation.
Time frame: Up to 28 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chlorhexidine Gluconate Bathing | Incidence of Nosocomial Infection | 15 participants |
| Standard Bathing | Incidence of Nosocomial Infection | 30 participants |
p-value: 0.04995% CI: [0.309, 0.998]Regression, Cox
Secondary
ICU Length of Stay in Days
Number of days in the ICU after enrollment in study until first ICU discharge.
Time frame: up to 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chlorhexidine Gluconate Bathing | ICU Length of Stay in Days | 7.2 days | Standard Deviation 11.4 |
| Standard Bathing | ICU Length of Stay in Days | 7.0 days | Standard Deviation 8.6 |
Secondary
Incidence of Skin Irritation
The incidence of new onset skin irritation will be recorded and graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03.
Time frame: up to 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chlorhexidine Gluconate Bathing | Incidence of Skin Irritation | 30 Participants |
| Standard Bathing | Incidence of Skin Irritation | 31 Participants |
Secondary
Number of Patients With In-hospital Mortality
Time frame: up to 28 days or until first hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chlorhexidine Gluconate Bathing | Number of Patients With In-hospital Mortality | 22 Participants |
| Standard Bathing | Number of Patients With In-hospital Mortality | 24 Participants |