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

• Sponsor: Baptist Health South Florida (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02082717
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arms: 2
• Actual Duration (Months): 53.2
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypokalemia	Drug: potassium chloride replacement; Drug: Experimental - 4% Sodium Bicarbonate	Phase 4

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

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: Feb 25, 2014
• Actual Primary Completion Date: Aug 3, 2018
• Actual Study Completion Date: Aug 3, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Neut (4%sodium bicarbonate additive) 4% sodium bicarbonate additive during intravenous potassium chloride replacement.	Drug: potassium chloride replacement; Drug: Experimental - 4% Sodium Bicarbonate
Active Comparator: Control standard of practice potassium chloride replacement (with no additive)	Drug: potassium chloride replacement

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West Kendall Baptist Hospital	Miami	Florida	United States	33196

Sponsors and Collaborators

• Baptist Health South Florida

Investigators

• Principal Investigator: Mavel Arinal, RN, BHSF

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 4, 2018

More Information

Publications

None provided.

• Responsible Party: Baptist Health South Florida
• ClinicalTrials.gov Identifier: NCT02082717
• Other Study ID Numbers: IRB # 13-060
• First Posted: Mar 10, 2014
• Last Update Posted: Apr 1, 2021
• Last Verified: Mar 1, 2021

• Additional relevant MeSH terms: Phlebitis; Hypokalemia

Study Results

Participant Flow

Arm/Group Title	Neut (4%Sodium Bicarbonate Additive)	Control
Arm/Group Description	4% sodium bicarbonate additive during intravenous potassium chloride replacement. potassium chloride replacement Experimental - 4% Sodium Bicarbonate	standard of practice potassium chloride replacement (with no additive) potassium chloride replacement
Period Title: Overall Study
STARTED	8	9
COMPLETED	8	9
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Neut (4%Sodium Bicarbonate Additive)	Control	Total
Arm/Group Description	4% sodium bicarbonate additive during intravenous potassium chloride replacement. potassium chloride replacement Experimental - 4% Sodium Bicarbonate	standard of practice potassium chloride replacement (with no additive) potassium chloride replacement	Total of all reporting groups
Overall Participants	8	9	17
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	5 62.5%	4 44.4%	9 52.9%
>=65 years	3 37.5%	5 55.6%	8 47.1%
Sex: Female, Male (Count of Participants)
Female	6 75%	9 100%	15 88.2%
Male	2 25%	0 0%	2 11.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 25%	0 0%	2 11.8%
White	6 75%	9 100%	15 88.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Indicated Findings
Description	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

Outcome Measure Data

Analysis Population Description

Due to the small number of participants enrolled, the statistical power would be too low for any significant findings.

Arm/Group Title	Neut (4%Sodium Bicarbonate Additive)	Control
Arm/Group Description	4% sodium bicarbonate additive during intravenous potassium chloride replacement. potassium chloride replacement Experimental - 4% Sodium Bicarbonate	standard of practice potassium chloride replacement (with no additive) potassium chloride replacement
Measure Participants	8	9
Pain at 15 min. at IV site	0 0%	1 11.1%
Pain at 1 hour at IV site	1 12.5%	0 0%
Pain at 2 hours at IV site	0 0%	2 22.2%
Pain at 3 hours at IV site	1 12.5%	2 22.2%
Pain at 4 hours at IV site	0 0%	0 0%
Pain at completion	0 0%	0 0%
Phlebitis (Erythema and Swelling at IV site) at 15 mins.	0 0%	1 11.1%
Phlebitis (Erythema and Swelling at IV site) at 1 hour	0 0%	0 0%
Phlebitis (Erythema and Swelling at IV site) at 2 hours	0 0%	0 0%
Phlebitis (Erythema and Swelling at IV site) at 3 hours	0 0%	0 0%
Phlebitis (Erythema and Swelling at IV site) at 4 hours	0 0%	0 0%
Slight pain and redness at IV site at 15 min	1 12.5%	3 33.3%
Slight pain and redness at IV site at 1 hour	3 37.5%	2 22.2%
Slight pain and redness at IV site at 2 hours	0 0%	2 22.2%
Slight pain and redness at IV site at 3 hours	0 0%	1 11.1%
Slight pain and redness at IV site at 4 hours	1 12.5%	0 0%
Slight pain and redness at IV site at completion	1 12.5%	0 0%

2. Secondary Outcome

Title	Number of Participants Nursing Interventions
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Neut (4%Sodium Bicarbonate Additive)	Control
Arm/Group Description	4% sodium bicarbonate additive during intravenous potassium chloride replacement. potassium chloride replacement Experimental - 4% Sodium Bicarbonate 3 participants out of 8 analyzed had pain medication during randomization.	standard of practice potassium chloride replacement (with no additive) potassium chloride replacement O participants out of 9 had no interventions
Measure Participants	8	9
Nursing Intervention - Pain medication	3 37.5%	0 0%
No nursing intervention	5 62.5%	9 100%

3. Secondary Outcome

Title	Attrition Rates
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Neut (4%Sodium Bicarbonate Additive)	Control
Arm/Group Description	4% sodium bicarbonate additive during intravenous potassium chloride replacement. potassium chloride replacement Experimental - 4% Sodium Bicarbonate Zero attrition rate	standard of practice potassium chloride replacement (with no additive) potassium chloride replacement Zero attrition rate
Measure Participants	8	9
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	Up to 4 hours
Arm/Group Title	Neut (4%Sodium Bicarbonate Additive)		Control
Arm/Group Description	4% sodium bicarbonate additive during intravenous potassium chloride replacement. potassium chloride replacement Experimental - 4% Sodium Bicarbonate		standard of practice potassium chloride replacement (with no additive) potassium chloride replacement
All Cause Mortality
	Neut (4%Sodium Bicarbonate Additive)		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/9 (0%)
Serious Adverse Events
	Neut (4%Sodium Bicarbonate Additive)		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/9 (0%)
Other (Not Including Serious) Adverse Events
	Neut (4%Sodium Bicarbonate Additive)		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/9 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.