Study of Sodium Bicarbonate in Restoring Blocked Catheters

Cancer Clinical Trial

Official title:

Sodium Bicarbonate Injections for Restoration of Flow in a Central Venous Catheter (CVC/Hickman Catheter) or Peripherally Inserted Central Venous Catheter (PICC)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03348826
• Other study ID #: SBI-FLOW
• Status: Withdrawn
• Phase: Phase 2
• Start date: June 1, 2020
• Est. completion date: September 2, 2021

Study information

• Verified date: September 2020
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study looking at the use of sodium bicarbonate to restore the flow of blocked central line devices in patients with blood cancers.

Central line devices uses thin tubes that are placed into a vein in the body to give medicines, fluids, nutrients, blood products, etc.

Sometimes, the lines become blocked. The standard procedure to get the line working again is to use alteplase, a protein that dissolves blood clots. While blood clotting is one cause of a blocked line, other reasons included the formation of calcium deposits. Sodium bicarbonate is routinely used in the treatment of patients receiving chemotherapy. Sodium bicarbonate is a liquid drug which is capable of dissolving protein and calcium deposits.

This study will compare whether sodium bicarbonate works just as well as alteplase to recover the function of a blocked line.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2, 2021
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hematology patients with indwelling CVC/PICC line.

• Patients continuing to receive chemotherapy treatment for consolidation, intensification and maintenance regimens in hematological malignancies such as in acute leukemia, lymphoma, myelodysplastic syndrome, supportive care measures using blood products, ongoing anti-infective treatments, and nutrition.

• Patients whose CVC/PICC line becomes obstructed during routine care are being identified and presented to attending physician and pharmacist.

• Mechanical obstruction having been ruled out by visual inspection and manipulation of the patient's posture or extremities or both.

Exclusion Criteria:

• Patients with hemodialysis line occlusions

• Anyone with documentation of prior history of alteplase allergy or hypersensitivity reactions

Related Conditions & MeSH terms

• Cancer
• Central Venous Catheterization

Intervention

Drug:
• Sodium Bicarbonate 8.4% Solution for Injection
3 mL injection into line with up to 2 injections administered
• Alteplase Injectable Solution
2 mL injection into line with up to 2 injections administered

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful clearance rate of sodium bicarbonate		3 hours
Primary	Successful clearance rate of alteplase		3 hours