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

Phase 4

Terminated

• Conditions: Hypokalemia
• Interventions: Drug: potassium chloride replacement; Drug: Experimental - 4% Sodium Bicarbonate

• Registration Number: NCT02082717
• Lead Sponsor: Baptist Health South Florida

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.

Study Timeline

• Study First Submitted: 2014-02-24
• Study Start: 2014-02-25
• Study First Submitted QC: 2014-03-07
• Study First Posted: 2014-03-10
• Primary Completion: 2018-08-03
• Study Completion: 2018-08-03
• Results First Submitted: 2020-09-18
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-05
• Last Update Submitted: 2021-03-05
• Results First Posted: 2021-04-01
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	potassium chloride replacement	standard of practice potassium chloride replacement (with no additive)
Neut (4%sodium bicarbonate additive)	potassium chloride replacement	4% sodium bicarbonate additive during intravenous potassium chloride replacement.
Neut (4%sodium bicarbonate additive)	Experimental - 4% Sodium Bicarbonate	4% sodium bicarbonate additive during intravenous potassium chloride replacement.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Indicated Findings	Up to 4 hours	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

Name	Time	Method
Number of Participants Nursing Interventions	Up to 4 hours	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	Up to 4 hours	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

Trial Locations

Locations (1)

West Kendall Baptist Hospital; 🇺🇸 Miami, Florida, United States