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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03627884
Recruitment Status : Completed
First Posted : August 14, 2018
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Adel S EL-Hennawy, Coney Island Hospital, Brooklyn, NY

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

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




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



Information from the National Library of Medicine

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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.
  Study Documents (Full-Text)

Documents provided by Adel S EL-Hennawy, Coney Island Hospital, Brooklyn, NY:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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