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

• ClinicalTrials.gov Identifier: NCT03627884
• Recruitment Status: Completed
• First Posted: August 14, 2018
• Last Update Posted: August 14, 2018
• Sponsor: Coney Island Hospital, Brooklyn, NY
• Information provided by (Responsible Party): Adel S EL-Hennawy, Coney Island Hospital, Brooklyn, NY

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
End Stage Renal Disease; Acute Renal Failure; Hemodialysis Catheter Infection; Hemodialysis Complication; Hemodialysis Access Failure; Hemodialysis Catheter-Associated Bacteremia	Drug: Sodium Bicarbonate Catheter Lock Solution; Drug: Normal Saline Catheter Lock Solution	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 451 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: 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
• Actual Study Start Date: October 1, 2016
• Actual Primary Completion Date: March 30, 2018
• Actual Study Completion Date: March 30, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Lumen Clot Formation [ Time Frame: Approximately 18 months ]
   Catheter Loss Due to Lumen Clot Formation
2. Catheter Related Infection [ Time Frame: Approximately 18 months ]
   Catheter Loss Due to Catheter Related Infection
3. Malfunction [ Time Frame: Approximately 18 months ]
   Catheter Loss Due to Malfunction
4. Overall Cause [ Time Frame: Approximately 18 months ]
   Catheter Loss Due to All Causes

Secondary Outcome Measures :

1. Death [ Time Frame: Approximately 18 months ]
   Number of deaths reported during the study period
2. Arrhythmia [ Time Frame: Approximately 18 months ]
   Incidence of significant arrhythmia during dialysis requiring urgent intervention
3. Hemodynamic Instability [ Time Frame: Approximately 18 months ]
   Incidence of extreme hypotension or hypertension requiring urgent intervention

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

  Study Documents (Full-Text)

Documents provided by Adel S EL-Hennawy, Coney Island Hospital, Brooklyn, NY:

Study Protocol and Statistical Analysis Plan  [PDF] June 25, 2015

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Adel S EL-Hennawy, Director of Nephrology, Coney Island Hospital, Brooklyn, NY
• ClinicalTrials.gov Identifier: NCT03627884
• Other Study ID Numbers: 2015-06-25
• First Posted: August 14, 2018
• Last Update Posted: August 14, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Adel S EL-Hennawy, Coney Island Hospital, Brooklyn, NY:

Central Venous Catheters; End Stage Renal Disease; Hemodialysis; Catheter-related infection; Catheter loss due to clot formation; Acute Renal Failure

Additional relevant MeSH terms:

Bacteremia; Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency; Acute Kidney Injury; Infections; Urologic Diseases; Renal Insufficiency, Chronic; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pharmaceutical Solutions