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N/A Completed N=80 Randomized Treatment

Comparison of Tesio and LifeCath Twin Permanent Dialysis Catheters

Source: ClinicalTrials.gov NCT01022359 ↗
Enrolled (actual)
80
Serious AEs
8.8%
Results posted
Apr 2021
Primary outcomePrimary: Blood Flow Rate at First Use After Insertion — 277; 383 mL/min

Summary

This study aims to compare two available types of central venous haemodialysis catheters (lines) - CVCs, and will examine how easy they are to insert, complications, blood flow on dialysis over time, line loss, line clotting and infective events. It will examine whether the LifeCath type of CVC can deliver high blood flow rates from first use after insertion and equivalent function and complication rate to the Tesio type of CVC that is in use in our centre already. Complications relating to dialysis access make up 30% of admissions for haemodialysis patients and so this is a study that could benefit patients and their care providers.

Outcome Measures

OutcomeResultp-value
PRIMARY
Blood Flow Rate at First Use After Insertion
277; 383
SECONDARY
Achievement of Flow Rates>=450ml/Min at Dialysis Session
361; 379
SECONDARY
Line Retention (Either/Both Lumens)
SECONDARY
Infective Episodes (Catheter & Non-catheter Related)
SECONDARY
Catheter Dysfunction Requiring Use of Thrombolytic Agents
0; 6
SECONDARY
Complications at Catheter Insertion
0; 0
SECONDARY
Recirculation Rates

Eligibility Criteria

Inclusion Criteria

  • Age >=18 years old
  • No history of prior central venous catheter insertion
  • Medically fit for procedure (able to lie flat, no haemodynamic instability)
  • No active infection (recent positive blood cultures, clinical signs of infection, CRP>100)
  • Able to give informed consent
  • Expected to survive more than 12 months after catheter insertion

Exclusion Criteria

  • As above
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01022359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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