Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Randomized, double-blind clinical trial to compare the efficacy of catheter sealing with saline, compared to low-dose heparin. 3,450 patients hospitalized at the Hospital Residencia Sant Camil, in Catalonia (Spain), will be randomized to each branch of study. The primary outcome will be the percentage of catheters removed due to obstruction in each branch of study. As secondary outcomes, the number of catheter-associated phlebitis, catheter-associated bacetrihemia, extravasation, and catheter loss will be measured. For the primary outcome, a superiority analysis will be carried out in terms of the percentage of obstructed catheters in each branch of the study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catheter sealing with low dose heparin | Experimental | Catheters will be sealed with 3mL of Fibrillin Ⓡ (heparin 20UI/mL) |
|
| Catheter sealing with normal saline | Active Comparator | Catheters will be sealed with 3mL of 0.9% sodium chloride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose heparin | Drug | Catheters will be sealed with 3 mL of Fibrillin Ⓡ (heparin 20UI/mL) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of obstructed catheters | percentage of obstructed catheters | From date of randomization through the date of hospital discharge, an average of 10 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of catheter-associated phlebitis | Number of catheter-associated phlebitis | From date of randomization through the date of hospital discharge, an average of 10 days. |
| Number of catheter-associated bacterihemia episodes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esther Moreno Rubio | Contact | 938960025 | 47158 | emoreno@csapg.cat |
| Noemà Casaponsa | Contact | +34 938960025 | 43917 | recerca@csapg.cat |
| Name | Affiliation | Role |
|---|---|---|
| Esther Moreno Rubio | CSAPG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Residència Sant Camil | Recruiting | Sant Pere de Ribes | Barcelona | 08810 | Spain |
IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research proposels and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
After publication of main results of the study
IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.
Not provided
Not provided
| ID | Term |
|---|---|
| D006493 | Heparin |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000077324 | Crystalloid Solutions |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Normal saline | Drug | Catheters will be sealed with 3mL of 0.9% sodium chloride |
|
Number of catheter-associated bacterihemia episodes
| From date of randomization through the date of hospital discharge, an average of 10 days. |
| Number of catheter loss due to extravasation | Number of catheter loss due to extravasation | From date of randomization through the date of hospital discharge, an average of 10 days. |
| D007552 |
| Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |