Clinical trial NCT04772209: Comparison of Effectiveness and Complications of Catheter Lock Solutions in Non-tunneled Hemodialysis Catheters
Official title: Comparison of Effectiveness and Complications of Heparin and Sodium Bicarbonate Catheter Lock Solutions in Non-Tunneled Hemodialysis Catheters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter Blockage
Catheter-Related Infections
Dialysis Catheter; Thrombosis
Catheter Infection
Catheter Related Complication
Catheter Dysfunction
Keywords: catheter lock solution
sodium bicarbonate
heparin
Non-tunneled dialysis catheter
Lead sponsor: Zonguldak Ataturk State Hospital
Sponsor class: OTHER
Collaborators: name: Cumhuriyet University
name: Sisli Hamidiye Etfal Training and Research Hospital
First posted: 2021-02-26
Enrollment: 441
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Bicarbonate vs Heparin group (femoral vs jugular catheter)
Primary purpose: DIAGNOSTIC

Brief summary: In our study, investigators will investigate the effectiveness and complications of two catheter lock solutions one of which is the standard heparin routinely used in comparison to Sodium bicarbonate. Both solutions were used but not compared head to head. Investigators aim to compare both solutions in terms of catheter lumen patency and their effect on catheter-related infections.

Detailed description: The most important problem in patients with end-stage renal disease or patients with acute renal failure needing urgent hemodialysis treatment is the lack of appropriate vascular access. In acute situations, vascular access is usually provided by non-tunneled catheters. Main problems with this temporaray vascular access is failure due to lumen thrombosis. anther major problem is catheter related infection. In some patients, there is a handicap of using heparin. In some situations, heparin is not preferred for use. In terms of the probable shortage of resources and cost-effectiveness, Investigators aimed to compare head to head the superiority and non-inferiority of each solution. Sodium bicarbonate was compared to the isotonic solution and found to be effective for a short time. The main aim of this study is to compare both classic Heparin and sodium bicarbonate in Femoral and Jugular catheters aimed for dialysis. In both arms, the maximum patency and the observed side effects will be recorded. The maximal time used will be recorded. statistical analysis will be planned to compare the two groups.

Eligibility criteria: Inclusion Criteria:

* All patients over 18 years who assign consent will be included

Exclusion Criteria:

* patients less than 18 years of age
* Patients with active arterial or venous thrombosis problems
* Thrombocytopenic patients
* Patients with hypercoagulable states
* Patients with contraindications to heparin usage

Primary outcomes:
measure: Time to first catheter failure (day)
timeFrame: 6 months
measure: Total Duration of catheter usage (day)
timeFrame: 6 months
measure: Number of participants with catheter occlusion
timeFrame: 6 months
measure: Number of patients with catheter related infection
timeFrame: 6 months
measure: Time of catheter occlusion or failure
timeFrame: 6 months
measure: Causes of premature catheter malfunction
timeFrame: 6 months
Secondary outcomes:
measure: Total number of dialysis sessions with active patent catheter usage
timeFrame: 6 months
measure: Number of cases with venous thrombosis
timeFrame: 6 months
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Cumhuriyet University Hospital
state: TN
city: Zonguldak
country: Turkey
facility: Zonguldak ataturk state hospital
state: TN
Study officials:
affiliation: Zonguldak Ataturk State Hospital
name: MAHMUD M ISLAM, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: El-Hennawy AS, Frolova E, Romney WA. Sodium bicarbonate catheter lock solution reduces hemodialysis catheter loss due to catheter-related thrombosis and blood stream infection: an open-label clinical trial. Nephrol Dial Transplant. 2019 Oct 1;34(10):1739-1745. doi: 10.1093/ndt/gfy388.