Trial Outcomes & Findings for Sodium Citrate 4% Locking Solution for Children Requiring Home Parenteral Nutrition (NCT NCT04756427)

Results Overview

Frequency of fever with positive central line blood culture events per central line days.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

12 months

Results posted on

2024-09-19

Participant Flow

Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.

Participant milestones

Participant milestones
Measure	Sodium Citrate 4% All enrolled participants will received the daily sodium citrate 4% locking solution for CLABSI prophylaxis intervention and be observed prospectively for adverse events Sodium Citrate 4% Inj Syringe 3Ml: 3 ml of sodium citrate 4% locking solution instilled into the central catheter daily during the period that parenteral nutrition is not infusing, and will be withdrawn and disposed of prior to resuming infusion of parenteral nutrition
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sodium Citrate 4% Locking Solution for Children Requiring Home Parenteral Nutrition

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 12 months

Population: Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.

Frequency of fever with positive central line blood culture events per central line days.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.

Central line thrombus events requiring anti-coagulation treatment per central line days.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.

Central line removal events (infection or other dysfunction) per central line days.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.

Serious adverse events will be assessed with number of hospitalizations for any reason.

Outcome measures

Outcome data not reported

Adverse Events

Sodium Citrate 4%

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

Darla Shores

Washington University

Phone: 314-454-6173

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place