HypokalemiaPhase 4Neut-WKBHNCT02082717
The Impact of Neut During Potassium Chloride Replacement on Pain and Incidence of Phlebitis
A Phase 4 study testing potassium chloride replacement and Experimental - 4% Sodium Bicarbonate in people with Hypokalemia, run by Baptist Health South Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hypokalemia
- What is being tested?
- potassium chloride replacement and Experimental - 4% Sodium Bicarbonate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2014to 3 Aug 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Hypokalemia
- Being tested
- potassium chloride replacement, Experimental - 4% Sodium Bicarbonate
- Medical subject headings
- Hypokalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
potassium chloride replacementDrug
Experimental - 4% Sodium BicarbonateDrug
| Study group | Role | What they receive |
|---|---|---|
| Neut (4%sodium bicarbonate additive) | Experimental | 4% sodium bicarbonate additive during intravenous potassium chloride replacement. Receives: Drug: potassium chloride replacement; Drug: Experimental - 4% Sodium Bicarbonate |
| Control | Active comparator | standard of practice potassium chloride replacement (with no additive) Receives: Drug: potassium chloride replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 hours
Secondary outcomes (2)
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
Measured: Up to 4 hours
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
Measured: Up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study start25 Feb 2014
- Primary completion3 Aug 2018
- Study completion3 Aug 2018
Why it stopped: Terminated due to medical supplies shortages due to the 2017 hurricane season.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypokalemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baptist Health South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mavel Arinal, RN, Principal investigator, BHSF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082717
- Sponsor's protocol ID
- IRB # 13-060
- Acronym
- Neut-WKBH
- Status last verified
- Mar 2021
- First submitted
- 24 Feb 2014
- Last updated
- 1 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02082717
- Acronym / sponsor ID
- Neut-WKBH / IRB # 13-060
- Conditions
- Hypokalemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to medical supplies shortages due to the 2017 hurricane season.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Baptist Health South FloridaUniversity, hospital or other
- Study start
- 25 Feb 2014 (actual)
- Primary completion
- 3 Aug 2018 (actual)
- Study completion
- 3 Aug 2018 (actual)
- First posted
- 10 Mar 2014 (estimated)
- Results
- Posted 1 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neut (4%sodium bicarbonate additive) | Experimental | Drug: potassium chloride replacement, Drug: Experimental - 4% Sodium Bicarbonate4% sodium bicarbonate additive during intravenous potassium chloride replacement. |
| Control | Active comparator | Drug: potassium chloride replacementstandard of practice potassium chloride replacement (with no additive) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| potassium chloride replacement | Drug | Control, Neut (4%sodium bicarbonate additive) |
| Experimental - 4% Sodium Bicarbonate | Drug | Neut (4%sodium bicarbonate additive) |
Primary outcome
Number of Participants With Indicated Findings
Time frame: Up to 4 hours
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.
2 secondary outcomes
Number of Participants Nursing Interventions
Time frame: Up to 4 hours
Attrition Rates
Time frame: Up to 4 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mavel Arinal, RN principal investigator
BHSF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing potassium chloride replacement and Experimental - 4% Sodium Bicarbonate in people with Hypokalemia, run by Baptist Health South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Indicated Findings (time frame: Up to 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.