Normal Saline Versus Heparin Intermittent Flushing for the Prevention of Occlusion in Port-a-Cath

Not Applicable

Not yet recruiting

• Conditions: Port-a-cath Occlusion; Normal Saline; Heparin Lock
• Interventions: Drug: Normal Saline Flush 20 ml; Drug: Normal Saline Flush 10 ml; Drug: Heparin Flush (1000 USP, 10ml)

• Registration Number: NCT05707936
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-28
• Study First Submitted QC: 2023-01-30
• Last Update Submitted: 2023-01-30
• Study Start: 2023-02-01
• Study First Posted: 2023-02-01
• Last Update Posted: 2023-02-01
• Primary Completion: 2023-09-01
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Normal saline 20 ml	Normal Saline Flush 20 ml	-
Normal saline 10 ml	Normal Saline Flush 10 ml	-
usual care (heparin)	Heparin Flush (1000 USP, 10ml)	-

Primary Outcome Measures

Name	Time	Method
port-a-cath infection	in hospitalized (during admission), up to 12 weeks	blood culture from port-A show bacterial growth
port-a-cath occlusion	in hospitalized (during admission), up to 12 weeks	failure to infusion fluid