Clinical trial NCT02082717: The Impact of Neut During Potassium Chloride Replacement on Pain and Incidence of Phlebitis
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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hypokalemia
Lead sponsor: Baptist Health South Florida
Sponsor class: OTHER
First posted: 2014-03-10
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Number of Participants With Indicated Findings
timeFrame: Up to 4 hours
Secondary outcomes:
measure: Number of Participants Nursing Interventions
timeFrame: Up to 4 hours
measure: Attrition Rates
timeFrame: Up to 4 hours
Other outcomes:
Locations:
city: Miami
country: United States
facility: West Kendall Baptist Hospital
state: Florida
Study officials:
affiliation: BHSF
name: Mavel Arinal, RN
role: PRINCIPAL_INVESTIGATOR
References: