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The efficacy and safety of 7.5% Sodium bicarbonate versus Heparin for Locking Solution of Acute temporal dailysis catheter : The randomized control study

Currently, there increase of acute kidney injusy and chronic kidney disease patient. In which these pateint need to renal replacement therapy, the non-cuff, non-tunnel double lumen are used for hemodialysis and heparin was a standard locking solution

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200630005
Enrollment
176
Registered
2020-06-30
Start date
2020-05-26
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Acute kidney injury or chronic kidney injury participants who underwent acute hemodialysis Locking solution&#44

Interventions

Use as locking solution in Double lumen in setting of acute hemodialysis participants after procedure and every sessions of hemodialysis&#44
dosage of solution is 1 ml dilute in NSS up to 3 ml and used amount of description in A&#45
line and V&#45
line on double lumen catheter,Use as locking solution in Double lumen in setting of acute hemodialysis participants after procedure and every sessions of hemodialysis&#44
dosage of solution are add on 0.1 ml amount of dosage description in A&#45
line on double lumen catheter&#44
not diluted with NSS
Placebo Comparator Drug,Active Comparator Drug
Heparin locking solution,7.5% NaHCO3 locking solution

Sponsors

Vajira hospital research foundation
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1.age > 18 yr 2.participants with non cuff venous catheter 3. participants receiving hemodialysis

Exclusion criteria

Exclusion criteria: 1.participants received warfarin, NOAC, or systemic heparin infusion 2.participants with abnormal coagulopathy 3 participants with history of CRBSI at least three months before study 4.participants with history of hypersensitivity to heparin 5. pregnancy 6. participants with low platelet count 30 mmol/dL 9.participants with symptomatic hypocalcemia 10.. participants does not consent

Design outcomes

Primary

MeasureTime frame
Efficacy and safety 28 day Catheter day function,Compare rate of complication 28 days Catheter dysfunction; thrombosis, fibrin sleeves, CRBSI

Secondary

MeasureTime frame
All cause mortality 28 days Incidence rate,Complication due to abnormal bleeding 28 days Incidence rate,Metabolic disturbance ; prolong aPTT, hypoK, hyperHCO3, low serum Ca 28 days Incidence rate

Countries

Thailand

Contacts

Public ContactChotaya Kaewsangsai

Vajira hospital, Navamindradhiraj university

netmednu@gmail.com092-9975664

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026