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Clinical Trials/NCT04772209
NCT04772209
Completed
Not Applicable

Comparison of Effectiveness and Complications of Heparin and Sodium Bicarbonate Catheter Lock Solutions in Non-Tunneled Hemodialysis Catheters

Zonguldak Ataturk State Hospital2 sites in 1 country441 target enrollmentFebruary 1, 2021

Overview

Phase
Not Applicable
Intervention
Sodium bicarbonate
Conditions
Catheter Blockage
Sponsor
Zonguldak Ataturk State Hospital
Enrollment
441
Locations
2
Primary Endpoint
Number of participants with catheter occlusion
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2021
End Date
March 30, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Zonguldak Ataturk State Hospital
Responsible Party
Principal Investigator
Principal Investigator

mahmud islam

Medical Director of Nephrology clinic

Zonguldak Ataturk State Hospital

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

Arms & Interventions

Sodium bicarbonate Arm

In this arm, the catheter lock solution is sodium bicarbonate

Intervention: Sodium bicarbonate

Heparin arm

In this arm, classic heparin will be used as a reference catheter lock solution (standard lock solution)

Intervention: Heparin

Outcomes

Primary Outcomes

Number of participants with catheter occlusion

Time Frame: 6 months

The number of cases early catheter

Number of patients with catheter related infection

Time Frame: 6 months

any catheter related infection(exit site, lumen inection etc) will be recorded

Time to first catheter failure (day)

Time Frame: 6 months

The time from first sucessful dialysis session to the last one (in days)

Total Duration of catheter usage (day)

Time Frame: 6 months

some patients need only 1-2 dialysis sessions while others may need too many sessions. In some cases a total of three dialysi sessions is whithin 3-4 days while others may need that number in wider range (e.g 10-14 days). Here both number and duraion effect is evaluated

Causes of premature catheter malfunction

Time Frame: 6 months

any catheter needing exchange prematurly will be be evaluated for mulfunction cause (etiher mechanical thromus or kink rtc.)

Time of catheter occlusion or failure

Time Frame: 6 months

catheteres occluded by thrombi will be documented

Secondary Outcomes

  • Number of cases with venous thrombosis(6 months)
  • Total number of dialysis sessions with active patent catheter usage(6 months)

Study Sites (2)

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