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The Impact of Neut During Potassium Chloride Replacement on Pain and Incidence of Phlebitis (Neut-WKBH)

Primary Purpose

Hypokalemia

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
potassium chloride replacement
Experimental - 4% Sodium Bicarbonate
Sponsored by
Baptist Health South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypokalemia

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • admitted to the medical/surgical unit within the last 24 to 48 hours
  • awake, alert, and oriented times three
  • 21 years old and greater
  • receiving first peripheral intravenous potassium chloride replacement therapy as ordered by physician or ARNP as part of care and regardless of research
  • potassium level of 3.5 mmol/L or less.

Exclusion Criteria:

  • patients who have been in the medical/surgical unit more than 48 hours.
  • altered mental status defined as not being awake, alert, and oriented times three
  • patients who already received intravenous potassium chloride replacement during the current admission and with the current IV access
  • patients receiving intravenous potassium replacement therapy through a central line
  • patients that are not ordered potassium replacement by physician or ARNP as part of their care while hospitalized.

Sites / Locations

  • West Kendall Baptist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neut (4%sodium bicarbonate additive)

Control

Arm Description

4% sodium bicarbonate additive during intravenous potassium chloride replacement.

standard of practice potassium chloride replacement (with no additive)

Outcomes

Primary Outcome Measures

Number of Participants With Indicated Findings
outcomes - phlebitis, pain at peripheral intravenous insertion site, frequency of changing IV access, and time for administration. experimental - 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy. control - standard of practice of no 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy.

Secondary Outcome Measures

Number of Participants Nursing Interventions
experimental - 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy control - standard of practice of no 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy
Attrition Rates
experimental - 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy. control - standard of practice of no 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy

Full Information

First Posted
February 24, 2014
Last Updated
March 5, 2021
Sponsor
Baptist Health South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT02082717
Brief Title
The Impact of Neut During Potassium Chloride Replacement on Pain and Incidence of Phlebitis
Acronym
Neut-WKBH
Official Title
The Impact of 4% Sodium Bicarbonate Additive During Potassium Chloride Replacement on Pain and Incidence of Phlebitis for Adult Patients in a Medical Surgical Unit: A Randomized Double Blinded Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to medical supplies shortages due to the 2017 hurricane season.
Study Start Date
February 25, 2014 (Actual)
Primary Completion Date
August 3, 2018 (Actual)
Study Completion Date
August 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baptist Health South Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to examine the impact of 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy for adult patients in a Medical/Surgical unit. Using a randomized controlled double blinded experimental study design, patients who are 21 years or older are alert, awake, and oriented at the time of enrollment and have been ordered peripheral intravenous potassium chloride replacement will be recruited from one Medical/Surgical during the first 24-48 hours of their admission.
Detailed Description
The specific aim of the study is: Aim 1: To compare patient outcomes (phlebitis, pain at peripheral IV insertion site, frequency of changing IV access, and time for administration) between the experimental (4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy) and control (standard of practice of no 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy) groups. Aim 2: To compare number and type of nursing interventions done during peripheral intravenous potassium chloride replacement therapy between the experimental (4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy) and control (standard of practice of no 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy) groups. Aim 3: To compare attrition rates and reasons between the experimental (4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy) and control (standard of practice of no 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy) groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypokalemia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neut (4%sodium bicarbonate additive)
Arm Type
Experimental
Arm Description
4% sodium bicarbonate additive during intravenous potassium chloride replacement.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
standard of practice potassium chloride replacement (with no additive)
Intervention Type
Drug
Intervention Name(s)
potassium chloride replacement
Intervention Type
Drug
Intervention Name(s)
Experimental - 4% Sodium Bicarbonate
Primary Outcome Measure Information:
Title
Number of Participants With Indicated Findings
Description
outcomes - phlebitis, pain at peripheral intravenous insertion site, frequency of changing IV access, and time for administration. experimental - 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy. control - standard of practice of no 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy.
Time Frame
Up to 4 hours
Secondary Outcome Measure Information:
Title
Number of Participants Nursing Interventions
Description
experimental - 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy control - standard of practice of no 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy
Time Frame
Up to 4 hours
Title
Attrition Rates
Description
experimental - 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy. control - standard of practice of no 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy
Time Frame
Up to 4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: admitted to the medical/surgical unit within the last 24 to 48 hours awake, alert, and oriented times three 21 years old and greater receiving first peripheral intravenous potassium chloride replacement therapy as ordered by physician or ARNP as part of care and regardless of research potassium level of 3.5 mmol/L or less. Exclusion Criteria: patients who have been in the medical/surgical unit more than 48 hours. altered mental status defined as not being awake, alert, and oriented times three patients who already received intravenous potassium chloride replacement during the current admission and with the current IV access patients receiving intravenous potassium replacement therapy through a central line patients that are not ordered potassium replacement by physician or ARNP as part of their care while hospitalized.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mavel Arinal, RN
Organizational Affiliation
BHSF
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Kendall Baptist Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33196
Country
United States

12. IPD Sharing Statement

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The Impact of Neut During Potassium Chloride Replacement on Pain and Incidence of Phlebitis

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