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Terminated due to medical supplies shortages due to the 2017 hurricane season.
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neut (4%sodium bicarbonate additive) | Experimental | 4% sodium bicarbonate additive during intravenous potassium chloride replacement. |
|
| Control | Active Comparator | standard of practice potassium chloride replacement (with no additive) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| potassium chloride replacement | Drug |
| ||
| Experimental - 4% Sodium Bicarbonate |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mavel Arinal, RN | BHSF | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Kendall Baptist Hospital | Miami | Florida | 33196 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Neut (4%Sodium Bicarbonate Additive) | 4% sodium bicarbonate additive during intravenous potassium chloride replacement. potassium chloride replacement Experimental - 4% Sodium Bicarbonate |
| FG001 | Control | standard of practice potassium chloride replacement (with no additive) potassium chloride replacement |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Neut (4%Sodium Bicarbonate Additive) | 4% sodium bicarbonate additive during intravenous potassium chloride replacement. potassium chloride replacement Experimental - 4% Sodium Bicarbonate |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Due to the small number of participants enrolled, the statistical power would be too low for any significant findings. | Posted | Count of Participants | Participants | Up to 4 hours |
|
Up to 4 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neut (4%Sodium Bicarbonate Additive) | 4% sodium bicarbonate additive during intravenous potassium chloride replacement. potassium chloride replacement Experimental - 4% Sodium Bicarbonate |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Diana D'Orazio-Garcia | Baptist Health South Florida | 786-594-9737 | DianaDO@baptisthealth.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 4, 2018 | Feb 2, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007008 | Hypokalemia |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
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| Drug |
|
| 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 |
| Up to 4 hours |
standard of practice potassium chloride replacement (with no additive)
potassium chloride replacement
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| Control |
standard of practice potassium chloride replacement (with no additive) potassium chloride replacement |
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | Up to 4 hours |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | Up to 4 hours |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Control | standard of practice potassium chloride replacement (with no additive) potassium chloride replacement | 0 | 9 | 0 | 9 | 0 | 9 |
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| D007287 |
| Inorganic Chemicals |
| D017670 | Sodium Compounds |