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

NCT ID: NCT02082717

Last Updated: 2021-04-01

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-25

Study Completion Date

2018-08-03

Brief Summary

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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

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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.

Conditions

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Hypokalemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Neut (4%sodium bicarbonate additive)

4% sodium bicarbonate additive during intravenous potassium chloride replacement.

Group Type EXPERIMENTAL

potassium chloride replacement

Intervention Type DRUG

Experimental - 4% Sodium Bicarbonate

Intervention Type DRUG

Control

standard of practice potassium chloride replacement (with no additive)

Group Type ACTIVE_COMPARATOR

potassium chloride replacement

Intervention Type DRUG

Interventions

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potassium chloride replacement

Intervention Type DRUG

Experimental - 4% Sodium Bicarbonate

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baptist Health South Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mavel Arinal, RN

Role: PRINCIPAL_INVESTIGATOR

BHSF

Locations

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West Kendall Baptist Hospital

Miami, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB # 13-060

Identifier Type: -

Identifier Source: org_study_id

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