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

Hypokalemia Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02082717
• Other study ID #: IRB # 13-060
• Status: Terminated
• Phase: Phase 4
• Start date: February 25, 2014
• Est. completion date: August 3, 2018

Study information

• Verified date: March 2021
• Source: Baptist Health South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: August 3, 2018
• Est. primary completion date: August 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypokalemia
• Phlebitis

Intervention

Drug:
• potassium chloride replacement

• Experimental - 4% Sodium Bicarbonate

Locations

Country	Name	City	State
United States	West Kendall Baptist Hospital	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Baptist Health South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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