NCT03627884

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
451

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

1.5 years

First QC Date

July 12, 2018

Last Update Submit

August 8, 2018

Conditions

End Stage Renal DiseaseAcute Renal FailureHemodialysis Catheter InfectionHemodialysis ComplicationHemodialysis Access FailureHemodialysis Catheter-Associated Bacteremia

Keywords

Central Venous CathetersEnd Stage Renal DiseaseHemodialysisCatheter-related infectionCatheter loss due to clot formationAcute Renal Failure

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • Death

    Approximately 18 months

  • Arrhythmia

    Approximately 18 months

  • Hemodynamic Instability

    Approximately 18 months

Study Arms (2)

Normal Saline Catheter Lock Solution Group

ACTIVE COMPARATOR

Patients receiving normal saline catheter locking solution

Drug: Normal Saline Catheter Lock Solution

Sodium Bicarbonate Catheter Lock Solution

ACTIVE COMPARATOR

Patients receiving sodium bicarbonate catheter locking solution

Drug: Sodium Bicarbonate Catheter Lock Solution

Interventions

Sodium Bicarbonate Catheter Lock SolutionDRUG

Using Sodium Bicarbonate Catheter Lock Solution

Sodium Bicarbonate Catheter Lock Solution
Normal Saline Catheter Lock SolutionDRUG

Using Sodium Bicarbonate Catheter Lock Solution

Normal Saline Catheter Lock Solution Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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: 30668833DERIVED

MeSH Terms

Conditions

Kidney Failure, ChronicAcute Kidney InjuryCatheter-Related Infections

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsInfections

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Nephrology

Study Record Dates

First Submitted

July 12, 2018

First Posted

August 14, 2018

Study Start

October 1, 2016

Primary Completion

March 30, 2018

Study Completion

March 30, 2018

Last Updated

August 14, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share