NCT05707936

Brief Summary

Purpose: An evidence implementation of a randomized controlled trial for whether there is the difference in intermittent flushing 0.9% normal saline and heparin? Design: a single-blind randomized controlled trial Method: This study is based on the 5A (Ask, Acquire, Appraise, Apply, Audit) of evidence health care step, and design randomized controlled trial for evidence implementation. We will include inpatients over 20 years-old adults in New Taipei City TuCheng Hospital, Taiwan, who need administration medicine by port-a-catcher. The sample size is 192 according to G-power software. Random allocation software has using for block randomization, would assign to group A: flushing with 0.9% normal saline 10ml, group B: flushing with 0.9% normal saline 20ml, and group C: flushing with heparin 100 USP/ml. SPSS 20.0 software for statistical analysis, mean or standard deviation, one- way ANOVA would use.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 1, 2023

Status Verified

October 1, 2022

Enrollment Period

7 months

First QC Date

October 28, 2022

Last Update Submit

January 30, 2023

Conditions

Port-a-cath OcclusionNormal SalineHeparin Lock

Outcome Measures

Primary Outcomes (2)

  • port-a-cath occlusion

    failure to infusion fluid

    in hospitalized (during admission), up to 12 weeks

  • port-a-cath infection

    blood culture from port-A show bacterial growth

    in hospitalized (during admission), up to 12 weeks

Study Arms (3)

Normal saline 20 ml

EXPERIMENTAL
Drug: Normal Saline Flush 20 ml

Normal saline 10 ml

EXPERIMENTAL
Drug: Normal Saline Flush 10 ml

usual care (heparin)

ACTIVE COMPARATOR
Drug: Heparin Flush (1000 USP, 10ml)

Interventions

Normal Saline Flush 20 mlDRUG

Normal Saline Flush 20 ml

Normal saline 20 ml
Normal Saline Flush 10 mlDRUG

Normal Saline Flush 10 ml

Normal saline 10 ml
Heparin Flush (1000 USP, 10ml)DRUG

Heparin Flush (1000 USP, 10ml)

usual care (heparin)

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-pediatric inpatients over 20 years of age with PAC placed for any disease and who need medication during hospitalization.

You may not qualify if:

  • History of PAC obstruction, continuous high volume drip via PAC, taking anticoagulant or antiplatelet agents, abnormal blood coagulation, pregnancy or contraceptive use, specified flushing solution by case

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2022

First Posted

February 1, 2023

Study Start

February 1, 2023

Primary Completion

September 1, 2023

Study Completion

December 31, 2023

Last Updated

February 1, 2023

Record last verified: 2022-10