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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 21 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02082717
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Baptist Health South Florida
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Mavel Arinal, RN
Principal Investigator Affiliation BHSF
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Hypokalemia
Additional Details

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.

Arms & Interventions

Arms

Experimental: Neut (4%sodium bicarbonate additive)

4% sodium bicarbonate additive during intravenous potassium chloride replacement.

Active Comparator: Control

standard of practice potassium chloride replacement (with no additive)

Interventions

Drug: - potassium chloride replacement

Drug: - Experimental - 4% Sodium Bicarbonate

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

West Kendall Baptist Hospital, Miami, Florida

Status

Address

West Kendall Baptist Hospital

Miami, Florida, 33196

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