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

Baptist Health South Florida logo

Baptist Health South Florida

Status and phase

Terminated
Phase 4

Conditions

Hypokalemia

Treatments

Drug: potassium chloride replacement
Drug: Experimental - 4% Sodium Bicarbonate

Study type

Interventional

Funder types

Other

Identifiers

NCT02082717
IRB # 13-060

Details and patient eligibility

About

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.

Full 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.

Enrollment

17 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

17 participants in 2 patient groups

Neut (4%sodium bicarbonate additive)
Experimental group
Description:
4% sodium bicarbonate additive during intravenous potassium chloride replacement.
Treatment:
Drug: Experimental - 4% Sodium Bicarbonate
Drug: potassium chloride replacement
Control
Active Comparator group
Description:
standard of practice potassium chloride replacement (with no additive)
Treatment:
Drug: potassium chloride replacement

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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