Outcomes of the Use of Sodium Bicarbonate (8.4%) Solution as a Catheter Lock Solution to Prevent Hemodialysis Catheter Loss Due to Lumen Clot Formation

Outcomes of the Use of Sodium Bicarbonate (8.4%) Solution as a Catheter Lock Solution as a Catheter Lock Solution to Prevent Hemodialysis Catheter Loss Due to Lumen Clot Formation

Prospective, randomized, comparative clinical and open-label trial comparing sodium bicarbonate catheter lock solution (SBCLS) to normal saline catheter lock solution (NSCLS) use in HD patients with central venous catheters (CVC).

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease; Hemodialysis Access Failure; Hemodialysis Complication; Acute Renal Failure; Hemodialysis Catheter Infection; Hemodialysis Catheter-Associated Bacteremia
• Intervention / Treatment: Drug: Normal Saline Catheter Lock Solution; Drug: Sodium Bicarbonate Catheter Lock Solution

Detailed Description

A randomized, comparative clinical, open-label trial at Coney Island Hospital, in Brooklyn, NY. The study period was between October 1, 2016 and March 30, 2018, a total of 546 days. All patients provided written informed consent before enrollment. The trial protocol was approved by Maimonides Medical Center Investigational Review Board: Study #2015-06-25-CIH. Patients presenting over the age of 18 requiring hemodialysis via CVCs were eligible. One patient was excluded due to having a poor venous system with inadequate blood flow for appropriate HD. No other patient was excluded from the study.

A total of 451 patients undergoing HD with CVCs were included in the study. Patients had tunneled internal jugular vein (IJV) catheters, non-tunneled IJV catheters, and non-tunneled femoral vein catheters. All patients were randomly assigned based on simple sequential order into one of two groups: NSCLS (n = 226) and SBCLS (n = 225). NSCLS patients were assigned between October 1, 2016 and June 30, 2017. SBCLS patients were assigned between July 1 2017 and March 30, 2018. Recruitment ended based on the similar number of enrolled participants between groups. A primary or co-investigator enrolled the participant into the trial and assigned the participant to the intervention at the time of presentation. Both groups received heparin-free HD treatment. Before each HD treatment, catheters and connections were inspected for leaks, evidence of damage, exit-site infection and tunnel infection. Intraluminal SBCLS or NSCLS lock solution was removed before connecting the HD catheter to a dialysis machine prior to any treatment.

During each treatment, patients were monitored for complications and standard care was provided to every patient. After each treatment, blood was rinsed from dialysis lines with NS solution back to the patient. Upon the conclusion of treatment, all catheters were flushed and locked with 10 mL of NSCLS or SBCLS, respective of their groups. Approximately 2 mL of the injected solution remained locked within the catheter. Catheter exit site dressing changes occurred after each HD treatment.

For patients that had clotted catheters, thrombolytic therapy was not instituted. Risk assessment performed by our hospital's risk management department determined that the net risk of thrombolytic use in their opinion was greater than the risk of catheter replacement by our qualified operators.

CVCs used in the study varied according to the patient's needs and consisted of Mahurkar non-tunneled catheters and Palindrome tunneled catheters. All CVCs were inserted by an expert operator under strict aseptic protocol. Catheter care was performed by trained dialysis staff according to our hospital's Administrative Policy and Procedure Manual. At the end of dialysis, all catheters were flushed and locked with one of two solutions. SBCLS contained 7.5% or 8.4% SB at a pH of 7.0-8.5, and was used to lock SBCLS-group catheters. NSCLS contained 0.9% sodium chloride at a pH 4.5-7.0, and was used to lock NSCLS-group patient catheters. Both are sterile non-pyrogenic solutions.

• Study Type: Interventional
• Enrollment (Actual): 451
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients presenting over the age of 18 requiring hemodialysis via CVCs were eligible.

Exclusion Criteria:

• Having a poor venous system with inadequate blood flow for appropriate HD.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Normal Saline Catheter Lock Solution Group; Patients receiving normal saline catheter locking solution	Drug: Normal Saline Catheter Lock Solution; Using Sodium Bicarbonate Catheter Lock Solution
Active Comparator: Sodium Bicarbonate Catheter Lock Solution; Patients receiving sodium bicarbonate catheter locking solution	Drug: Sodium Bicarbonate Catheter Lock Solution; Using Sodium Bicarbonate Catheter Lock Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lumen Clot Formation	Catheter Loss Due to Lumen Clot Formation	Approximately 18 months
Catheter Related Infection	Catheter Loss Due to Catheter Related Infection	Approximately 18 months
Malfunction	Catheter Loss Due to Malfunction	Approximately 18 months
Overall Cause	Catheter Loss Due to All Causes	Approximately 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Number of deaths reported during the study period	Approximately 18 months
Arrhythmia	Incidence of significant arrhythmia during dialysis requiring urgent intervention	Approximately 18 months
Hemodynamic Instability	Incidence of extreme hypotension or hypertension requiring urgent intervention	Approximately 18 months

Collaborators and Investigators

• Sponsor: Coney Island Hospital, Brooklyn, NY

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): October 1, 2016
• Primary Completion (Actual): March 30, 2018
• Study Completion (Actual): March 30, 2018

Study Registration Dates

• First Submitted: July 12, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): August 14, 2018
• Last Update Submitted That Met QC Criteria: August 8, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: End Stage Renal Disease; Hemodialysis; Acute Renal Failure; Central Venous Catheters; Catheter-related infection; Catheter loss due to clot formation
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Urologic Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency; Bacteremia; Acute Kidney Injury; Pharmaceutical Solutions
• Other Study ID Numbers: 2015-06-25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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