Hypokalemia
Conditions
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.
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.
Interventions
DRUGpotassium chloride replacement
DRUGExperimental - 4% Sodium Bicarbonate
Sponsors
Baptist Health South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Indicated Findings | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Nursing Interventions | Up to 4 hours | 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 |
| Attrition Rates | Up to 4 hours | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Neut (4%Sodium Bicarbonate Additive) 4% sodium bicarbonate additive during intravenous potassium chloride replacement.
potassium chloride replacement
Experimental - 4% Sodium Bicarbonate | 8 |
| Control standard of practice potassium chloride replacement (with no additive)
potassium chloride replacement | 9 |
| Total | 17 |
Baseline characteristics
| Characteristic | Neut (4%Sodium Bicarbonate Additive) | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 5 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 9 Participants | 15 Participants |
| Sex: Female, Male Female | 6 Participants | 9 Participants | 15 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 9 |
| other Total, other adverse events | 0 / 8 | 0 / 9 |
| serious Total, serious adverse events | 0 / 8 | 0 / 9 |
Outcome results
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.
Time frame: Up to 4 hours
Population: Due to the small number of participants enrolled, the statistical power would be too low for any significant findings.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Neut (4%Sodium Bicarbonate Additive) | Number of Participants With Indicated Findings | Pain at completion | 0 Participants |
| Neut (4%Sodium Bicarbonate Additive) | Number of Participants With Indicated Findings | Phlebitis (Erythema and Swelling at IV site) at 3 hours | 0 Participants |
| Neut (4%Sodium Bicarbonate Additive) | Number of Participants With Indicated Findings | Pain at 1 hour at IV site | 1 Participants |
| Neut (4%Sodium Bicarbonate Additive) | Number of Participants With Indicated Findings | Phlebitis (Erythema and Swelling at IV site) at 4 hours | 0 Participants |
| Neut (4%Sodium Bicarbonate Additive) | Number of Participants With Indicated Findings | Pain at 3 hours at IV site | 1 Participants |
| Neut (4%Sodium Bicarbonate Additive) | Number of Participants With Indicated Findings | Slight pain and redness at IV site at 15 min | 1 Participants |
| Neut (4%Sodium Bicarbonate Additive) | Number of Participants With Indicated Findings | Phlebitis (Erythema and Swelling at IV site) at 15 mins. | 0 Participants |
| Neut (4%Sodium Bicarbonate Additive) | Number of Participants With Indicated Findings | Slight pain and redness at IV site at 1 hour | 3 Participants |
| Neut (4%Sodium Bicarbonate Additive) | Number of Participants With Indicated Findings | Pain at 2 hours at IV site | 0 Participants |
| Neut (4%Sodium Bicarbonate Additive) | Number of Participants With Indicated Findings | Slight pain and redness at IV site at 2 hours | 0 Participants |
| Neut (4%Sodium Bicarbonate Additive) | Number of Participants With Indicated Findings | Phlebitis (Erythema and Swelling at IV site) at 1 hour | 0 Participants |
| Neut (4%Sodium Bicarbonate Additive) | Number of Participants With Indicated Findings | Slight pain and redness at IV site at 3 hours | 0 Participants |
| Neut (4%Sodium Bicarbonate Additive) | Number of Participants With Indicated Findings | Pain at 4 hours at IV site | 0 Participants |
| Neut (4%Sodium Bicarbonate Additive) | Number of Participants With Indicated Findings | Slight pain and redness at IV site at 4 hours | 1 Participants |
| Neut (4%Sodium Bicarbonate Additive) | Number of Participants With Indicated Findings | Phlebitis (Erythema and Swelling at IV site) at 2 hours | 0 Participants |
| Neut (4%Sodium Bicarbonate Additive) | Number of Participants With Indicated Findings | Slight pain and redness at IV site at completion | 1 Participants |
| Neut (4%Sodium Bicarbonate Additive) | Number of Participants With Indicated Findings | Pain at 15 min. at IV site | 0 Participants |
| Control | Number of Participants With Indicated Findings | Slight pain and redness at IV site at completion | 0 Participants |
| Control | Number of Participants With Indicated Findings | Pain at 15 min. at IV site | 1 Participants |
| Control | Number of Participants With Indicated Findings | Pain at 1 hour at IV site | 0 Participants |
| Control | Number of Participants With Indicated Findings | Pain at 2 hours at IV site | 2 Participants |
| Control | Number of Participants With Indicated Findings | Pain at 3 hours at IV site | 2 Participants |
| Control | Number of Participants With Indicated Findings | Pain at 4 hours at IV site | 0 Participants |
| Control | Number of Participants With Indicated Findings | Pain at completion | 0 Participants |
| Control | Number of Participants With Indicated Findings | Phlebitis (Erythema and Swelling at IV site) at 15 mins. | 1 Participants |
| Control | Number of Participants With Indicated Findings | Phlebitis (Erythema and Swelling at IV site) at 1 hour | 0 Participants |
| Control | Number of Participants With Indicated Findings | Phlebitis (Erythema and Swelling at IV site) at 2 hours | 0 Participants |
| Control | Number of Participants With Indicated Findings | Phlebitis (Erythema and Swelling at IV site) at 3 hours | 0 Participants |
| Control | Number of Participants With Indicated Findings | Phlebitis (Erythema and Swelling at IV site) at 4 hours | 0 Participants |
| Control | Number of Participants With Indicated Findings | Slight pain and redness at IV site at 15 min | 3 Participants |
| Control | Number of Participants With Indicated Findings | Slight pain and redness at IV site at 1 hour | 2 Participants |
| Control | Number of Participants With Indicated Findings | Slight pain and redness at IV site at 2 hours | 2 Participants |
| Control | Number of Participants With Indicated Findings | Slight pain and redness at IV site at 3 hours | 1 Participants |
| Control | Number of Participants With Indicated Findings | Slight pain and redness at IV site at 4 hours | 0 Participants |
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
Time frame: Up to 4 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Neut (4%Sodium Bicarbonate Additive) | Attrition Rates | 0 Participants |
| Control | Attrition Rates | 0 Participants |
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
Time frame: Up to 4 hours
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Neut (4%Sodium Bicarbonate Additive) | Number of Participants Nursing Interventions | Nursing Intervention - Pain medication | 3 Participants |
| Neut (4%Sodium Bicarbonate Additive) | Number of Participants Nursing Interventions | No nursing intervention | 5 Participants |
| Control | Number of Participants Nursing Interventions | Nursing Intervention - Pain medication | 0 Participants |
| Control | Number of Participants Nursing Interventions | No nursing intervention | 9 Participants |