A Phase 4 interventional study of potassium chloride replacement and Experimental - 4% Sodium Bicarbonate in Hypokalemia, sponsored by Baptist Health South Florida. Terminated at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2021-04-01.
Sponsored by Baptist Health South Florida · Phase 4, Interventional, and Supportive care
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.
38 studies on the registry are indexed under Hypokalemia; 5 are open to participants now.
This study's enrollment of 17 is below the median of 77 across 29 interventional studies indexed under Hypokalemia.
Browse Hypokalemia studies →Baptist Health South Florida is the lead sponsor of 52 studies on the registry; 18 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.
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Exclusion Criteria:
4% sodium bicarbonate additive during intravenous potassium chloride replacement.
Drug: potassium chloride replacement · Drug: Experimental - 4% Sodium Bicarbonate
standard of practice potassium chloride replacement (with no additive)
Drug: potassium chloride replacement
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
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
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
| Milestone | Neut (4%Sodium Bicarbonate Additive) | Control |
|---|---|---|
| Started | 8 | 9 |
| Completed | 8 | 9 |
| Not completed | 0 | 0 |
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.
| Participants | Neut (4%Sodium Bicarbonate Additive) | Control |
|---|---|---|
| Pain at 15 min. at IV site | 0 | 1 |
| Pain at 1 hour at IV site | 1 | 0 |
| Pain at 2 hours at IV site | 0 | 2 |
| Pain at 3 hours at IV site | 1 | 2 |
| Pain at 4 hours at IV site | 0 | 0 |
| Pain at completion | 0 | 0 |
| Phlebitis (Erythema and Swelling at IV site) at 15 mins. | 0 | 1 |
| Phlebitis (Erythema and Swelling at IV site) at 1 hour | 0 | 0 |
| Phlebitis (Erythema and Swelling at IV site) at 2 hours | 0 | 0 |
| Phlebitis (Erythema and Swelling at IV site) at 3 hours | 0 | 0 |
| Phlebitis (Erythema and Swelling at IV site) at 4 hours | 0 | 0 |
| Slight pain and redness at IV site at 15 min | 1 | 3 |
| Slight pain and redness at IV site at 1 hour | 3 | 2 |
| Slight pain and redness at IV site at 2 hours | 0 | 2 |
| Slight pain and redness at IV site at 3 hours | 0 | 1 |
| Slight pain and redness at IV site at 4 hours | 1 | 0 |
| Slight pain and redness at IV site at completion | 1 | 0 |
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
| Participants | Neut (4%Sodium Bicarbonate Additive) | Control |
|---|---|---|
| Nursing Intervention - Pain medication | 3 | 0 |
| No nursing intervention | 5 | 9 |
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
| Participants | Neut (4%Sodium Bicarbonate Additive) | Control |
|---|---|---|
| Attrition Rates | 0 | 0 |
Collected over Up to 4 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Neut (4%Sodium Bicarbonate Additive) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Control | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Age, Categorical(Participants) | Neut (4%Sodium Bicarbonate Additive) | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 4 | 9 |
| >=65 years | 3 | 5 | 8 |
| Sex: Female, Male(Participants) | Neut (4%Sodium Bicarbonate Additive) | Control | Total |
|---|---|---|---|
| Female | 6 | 9 | 15 |
| Male | 2 | 0 | 2 |
| Race (NIH/OMB)(Participants) | Neut (4%Sodium Bicarbonate Additive) | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 2 |
| White | 6 | 9 | 15 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Feb 2014 to primary completion in Aug 2018, 53 months.
Results were first posted in Apr 2021, 2 years 7 months after primary completion.
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This study is terminated, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Baptist Health South Florida