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

NCT04772209 | Completed

• 1 other identifier: ZADH-1
• Study Type: interventional
• Target: 441
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (6)

• Time to first catheter failure (day)

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

  6 months

• 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

  6 months

• Number of participants with catheter occlusion

  The number of cases early catheter

  6 months

• Number of patients with catheter related infection

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

  6 months

• Time of catheter occlusion or failure

  catheteres occluded by thrombi will be documented

  6 months

• Causes of premature catheter malfunction

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

  6 months

Secondary Outcomes (2)

• Total number of dialysis sessions with active patent catheter usage

  6 months

• Number of cases with venous thrombosis

  6 months

Study Arms (2)

Sodium bicarbonate Arm

ACTIVE COMPARATOR

In this arm, the catheter lock solution is sodium bicarbonate

Drug: Sodium bicarbonate

Heparin arm

ACTIVE COMPARATOR

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

Drug: Heparin

Interventions

Sodium bicarbonate DRUG

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.

Sodium bicarbonate Arm

Heparin DRUG

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.

Heparin arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zonguldak Ataturk State Hospital: lead
• Cumhuriyet University: collaborator
• Sisli Hamidiye Etfal Training and Research Hospital: collaborator

Study Sites (2)

Cumhuriyet University Hospital

Sivas, TN, 34762, Turkey (Türkiye)

Location

Zonguldak ataturk state hospital

Zonguldak, TN, 67100, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 30668833 BACKGROUND

• Islam M. Sodium bicarbonate is a potential alternative to classic heparin as a lock solution for non-tunneled dialysis catheters: a result from the prospective randomized BicarbLock trial. Int Urol Nephrol. 2024 Apr;56(4):1465-1474. doi: 10.1007/s11255-023-03821-9. Epub 2023 Oct 12.

  PMID: 37823971 DERIVED

MeSH Terms

Conditions

Catheter-Related Infections; Thrombosis

Interventions

Sodium Bicarbonate; Heparin

Condition Hierarchy (Ancestors)

Infections; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• MAHMUD M ISLAM, MD

  Zonguldak Ataturk State Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of Nephrology clinic

Model Details: Bicarbonate vs Heparin group (femoral vs jugular catheter)

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 26, 2021
• Study Start: February 1, 2021
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting in February 2021 ends in September 2021
• Access Criteria: The inquired information will be sent by e-mail

Locations

TU (2)