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Comparison of Effectiveness and Complications of Catheter Lock Solutions in Non-tunneled Hemodialysis Catheters

Primary Purpose

Catheter Blockage, Catheter-Related Infections, Dialysis Catheter; Thrombosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Sodium bicarbonate
Heparin
Sponsored by
Zonguldak Ataturk State Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Catheter Blockage focused on measuring catheter lock solution, sodium bicarbonate, heparin, Non-tunneled dialysis catheter

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cumhuriyet University Hospital
  • Zonguldak ataturk state hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sodium bicarbonate Arm

Heparin arm

Arm Description

In this arm, the catheter lock solution is sodium bicarbonate

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

Outcomes

Primary Outcome Measures

Time to first catheter failure (day)
The time from first sucessful dialysis session to the last one (in days)
Total Duration of catheter usage (day)
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
Number of participants with catheter occlusion
The number of cases early catheter
Number of patients with catheter related infection
any catheter related infection(exit site, lumen inection etc) will be recorded
Time of catheter occlusion or failure
catheteres occluded by thrombi will be documented
Causes of premature catheter malfunction
any catheter needing exchange prematurly will be be evaluated for mulfunction cause (etiher mechanical thromus or kink rtc.)

Secondary Outcome Measures

Total number of dialysis sessions with active patent catheter usage
In some cases intensive treatment is indicated. the effect of frequent usage of catheteres will be evaluated
Number of cases with venous thrombosis
catheters especially femoral have a risk of venous thrombosis, any clincal sign of thrombosis will be recorded. In case of catheter removal doppler ultrasound will be documented.

Full Information

First Posted
February 15, 2021
Last Updated
June 11, 2023
Sponsor
Zonguldak Ataturk State Hospital
Collaborators
Cumhuriyet University, Sisli Hamidiye Etfal Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04772209
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
March 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zonguldak Ataturk State Hospital
Collaborators
Cumhuriyet University, Sisli Hamidiye Etfal Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Bicarbonate vs Heparin group (femoral vs jugular catheter)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
441 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sodium bicarbonate Arm
Arm Type
Active Comparator
Arm Description
In this arm, the catheter lock solution is sodium bicarbonate
Arm Title
Heparin arm
Arm Type
Active Comparator
Arm Description
In this arm, classic heparin will be used as a reference catheter lock solution (standard lock solution)
Intervention Type
Drug
Intervention Name(s)
Sodium bicarbonate
Intervention Description
Dialysis catheter lumen will be filled (locked) by sodium bicarbonate solution. The amount of solution depends on the diameter and length and will be in accordance with the manufacturer's specifications.
Intervention Type
Drug
Intervention Name(s)
Heparin
Intervention Description
Dialysis catheter lumen will be filled (locked) by classic heparin. The amount of pure heparin depends on the diameter and length and will be in accordance with the manufacturer's specifications.
Primary Outcome Measure Information:
Title
Time to first catheter failure (day)
Description
The time from first sucessful dialysis session to the last one (in days)
Time Frame
6 months
Title
Total Duration of catheter usage (day)
Description
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
Time Frame
6 months
Title
Number of participants with catheter occlusion
Description
The number of cases early catheter
Time Frame
6 months
Title
Number of patients with catheter related infection
Description
any catheter related infection(exit site, lumen inection etc) will be recorded
Time Frame
6 months
Title
Time of catheter occlusion or failure
Description
catheteres occluded by thrombi will be documented
Time Frame
6 months
Title
Causes of premature catheter malfunction
Description
any catheter needing exchange prematurly will be be evaluated for mulfunction cause (etiher mechanical thromus or kink rtc.)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Total number of dialysis sessions with active patent catheter usage
Description
In some cases intensive treatment is indicated. the effect of frequent usage of catheteres will be evaluated
Time Frame
6 months
Title
Number of cases with venous thrombosis
Description
catheters especially femoral have a risk of venous thrombosis, any clincal sign of thrombosis will be recorded. In case of catheter removal doppler ultrasound will be documented.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MAHMUD M ISLAM, MD
Organizational Affiliation
Zonguldak Ataturk State Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cumhuriyet University Hospital
City
Sivas
State/Province
TN
ZIP/Postal Code
34762
Country
Turkey
Facility Name
Zonguldak ataturk state hospital
City
Zonguldak
State/Province
TN
ZIP/Postal Code
67100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The study protocol and methods will be available in a paper intended for publication, any materials or data may be available on demand
IPD Sharing Time Frame
Starting in February 2021 ends in September 2021
IPD Sharing Access Criteria
The inquired information will be sent by e-mail
Citations:
PubMed Identifier
30668833
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.
Results Reference
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Learn more about this trial

Comparison of Effectiveness and Complications of Catheter Lock Solutions in Non-tunneled Hemodialysis Catheters

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