Trial Outcomes & Findings for The Impact of Neut During Potassium Chloride Replacement on Pain and Incidence of Phlebitis (NCT NCT02082717)

NCT ID: NCT02082717

Last Updated: 2021-04-01

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

17 participants

Primary outcome timeframe

Up to 4 hours

Results posted on

2021-04-01

Participant Flow

Participant milestones

Participant milestones
Measure	Neut (4%Sodium Bicarbonate Additive) 4% sodium bicarbonate additive during intravenous potassium chloride replacement. potassium chloride replacement Experimental - 4% Sodium Bicarbonate	Control standard of practice potassium chloride replacement (with no additive) potassium chloride replacement
Overall Study STARTED	8	9
Overall Study COMPLETED	8	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neut (4%Sodium Bicarbonate Additive) n=8 Participants 4% sodium bicarbonate additive during intravenous potassium chloride replacement. potassium chloride replacement Experimental - 4% Sodium Bicarbonate	Control n=9 Participants standard of practice potassium chloride replacement (with no additive) potassium chloride replacement	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 4 hours

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

Outcome measures

Outcome measures
Measure	Neut (4%Sodium Bicarbonate Additive) n=8 Participants 4% sodium bicarbonate additive during intravenous potassium chloride replacement. potassium chloride replacement Experimental - 4% Sodium Bicarbonate	Control n=9 Participants standard of practice potassium chloride replacement (with no additive) potassium chloride replacement
Number of Participants With Indicated Findings Pain at 15 min. at IV site	0 Participants	1 Participants
Number of Participants With Indicated Findings Pain at 1 hour at IV site	1 Participants	0 Participants
Number of Participants With Indicated Findings Pain at 2 hours at IV site	0 Participants	2 Participants
Number of Participants With Indicated Findings Pain at 3 hours at IV site	1 Participants	2 Participants
Number of Participants With Indicated Findings Pain at 4 hours at IV site	0 Participants	0 Participants
Number of Participants With Indicated Findings Pain at completion	0 Participants	0 Participants
Number of Participants With Indicated Findings Phlebitis (Erythema and Swelling at IV site) at 15 mins.	0 Participants	1 Participants
Number of Participants With Indicated Findings Phlebitis (Erythema and Swelling at IV site) at 1 hour	0 Participants	0 Participants
Number of Participants With Indicated Findings Phlebitis (Erythema and Swelling at IV site) at 2 hours	0 Participants	0 Participants
Number of Participants With Indicated Findings Phlebitis (Erythema and Swelling at IV site) at 3 hours	0 Participants	0 Participants
Number of Participants With Indicated Findings Phlebitis (Erythema and Swelling at IV site) at 4 hours	0 Participants	0 Participants
Number of Participants With Indicated Findings Slight pain and redness at IV site at 15 min	1 Participants	3 Participants
Number of Participants With Indicated Findings Slight pain and redness at IV site at 1 hour	3 Participants	2 Participants
Number of Participants With Indicated Findings Slight pain and redness at IV site at 2 hours	0 Participants	2 Participants
Number of Participants With Indicated Findings Slight pain and redness at IV site at 3 hours	0 Participants	1 Participants
Number of Participants With Indicated Findings Slight pain and redness at IV site at 4 hours	1 Participants	0 Participants
Number of Participants With Indicated Findings Slight pain and redness at IV site at completion	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Neut (4%Sodium Bicarbonate Additive) n=8 Participants 4% sodium bicarbonate additive during intravenous potassium chloride replacement. potassium chloride replacement Experimental - 4% Sodium Bicarbonate	Control n=9 Participants standard of practice potassium chloride replacement (with no additive) potassium chloride replacement
Number of Participants Nursing Interventions Nursing Intervention - Pain medication	3 Participants	0 Participants
Number of Participants Nursing Interventions No nursing intervention	5 Participants	9 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Neut (4%Sodium Bicarbonate Additive) n=8 Participants 4% sodium bicarbonate additive during intravenous potassium chloride replacement. potassium chloride replacement Experimental - 4% Sodium Bicarbonate	Control n=9 Participants standard of practice potassium chloride replacement (with no additive) potassium chloride replacement
Attrition Rates	0 Participants	0 Participants

Adverse Events

Neut (4%Sodium Bicarbonate Additive)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Diana D'Orazio-Garcia

Baptist Health South Florida

Phone: 786-594-9737

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place