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

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

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.

Study Overview

• Status: Terminated
• Conditions: Hypokalemia
• Intervention / Treatment: Drug: potassium chloride replacement; Drug: Experimental - 4% Sodium Bicarbonate

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33196
      • West Kendall Baptist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neut (4%sodium bicarbonate additive); 4% sodium bicarbonate additive during intravenous potassium chloride replacement.	Drug: potassium chloride replacement; Drug: Experimental - 4% Sodium Bicarbonate
Active Comparator: Control; standard of practice potassium chloride replacement (with no additive)	Drug: potassium chloride replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 4 hours
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	Up to 4 hours

Collaborators and Investigators

• Sponsor: Baptist Health South Florida
• Investigators: Principal Investigator: Mavel Arinal, RN, BHSF

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2014
• Primary Completion (Actual): August 3, 2018
• Study Completion (Actual): August 3, 2018

Study Registration Dates

• First Submitted: February 24, 2014
• First Submitted That Met QC Criteria: March 7, 2014
• First Posted (Estimate): March 10, 2014

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 5, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Vasculitis; Peripheral Vascular Diseases; Water-Electrolyte Imbalance; Phlebitis; Hypokalemia
• Other Study ID Numbers: IRB # 13-060