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

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

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.

Study Overview

• Status: Completed
• Conditions: Catheter Infection; Catheter-Related Infections; Catheter Blockage; Dialysis Catheter; Thrombosis; Catheter Related Complication; Catheter Dysfunction
• Intervention / Treatment: Drug: Sodium bicarbonate; Drug: Heparin

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.

• Study Type: Interventional
• Enrollment (Actual): 441
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MAHMUD ISLAM, MD; Phone Number: 00905556551458; Email: drisleem@gmail.com
• Study Contact Backup: Name: Yener koç, PHD; Phone Number: 00905055618780; Email: yenerkoc@cumhuriyet.edu.tr

Study Locations

• Turkey
  • TN
    • Sivas, TN, Turkey, 34762
      • Cumhuriyet University Hospital
    • Zonguldak, TN, Turkey, 67100
      • Zonguldak Ataturk State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sodium bicarbonate Arm; In this arm, the catheter lock solution is sodium bicarbonate	Drug: Sodium bicarbonate; 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.
Active Comparator: Heparin arm; In this arm, classic heparin will be used as a reference catheter lock solution (standard lock solution)	Drug: Heparin; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months
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.	6 months

Collaborators and Investigators

• Sponsor: Zonguldak Ataturk State Hospital
• Collaborators: Sisli Hamidiye Etfal Training and Research Hospital; Cumhuriyet University
• Investigators: Principal Investigator: MAHMUD M ISLAM, MD, Zonguldak Ataturk State Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): March 30, 2022

Study Registration Dates

• First Submitted: February 15, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 11, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: sodium bicarbonate; heparin; catheter lock solution; Non-tunneled dialysis catheter
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Embolism and Thrombosis; Infections; Communicable Diseases; Thrombosis; Catheter-Related Infections; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin
• Other Study ID Numbers: ZADH-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No