Study of Sodium Bicarbonate in Restoring Blocked Catheters

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03348826

Enrollment

Registered

2017-11-21

Start date

2020-06-01

Completion date

2021-09-02

Last updated

2020-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Central Venous Catheterization

Brief 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.

Interventions

DRUGSodium Bicarbonate 8.4% Solution for Injection

3 mL injection into line with up to 2 injections administered

DRUGAlteplase Injectable Solution

2 mL injection into line with up to 2 injections administered

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Successful clearance rate of sodium bicarbonate	3 hours
Successful clearance rate of alteplase	3 hours

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026