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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02082717
Recruitment Status : Enrolling by invitation
First Posted : March 10, 2014
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypokalemia Drug: potassium chloride replacement Drug: Experimental - 4% Sodium Bicarbonate Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
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 Start Date : February 2014
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

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



Primary Outcome Measures :
  1. Patient outcomes between the experimental and control groups. [ Time Frame: 1 year ]

    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 :
  1. Number and type of nursing interventions done during peripheral intravenous potassium chloride replacement therapy between experimental and control groups [ Time Frame: 1 year ]

    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


  2. Attrition rates and reasons between the experimental and control groups [ Time Frame: 1 year ]

    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




Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082717


Locations
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United States, Florida
West Kendall Baptist Hospital
Miami, Florida, United States, 33196
Sponsors and Collaborators
Baptist Health South Florida
Investigators
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Principal Investigator: Mavel Arinal, RN BHSF
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Responsible Party: Baptist Health South Florida
ClinicalTrials.gov Identifier: NCT02082717    
Other Study ID Numbers: IRB # 13-060
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Phlebitis
Hypokalemia
Water-Electrolyte Imbalance
Metabolic Diseases
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Vasculitis