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

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05707936

Collaborator

(none)

192

Enrollment

Arms

10.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Port-a-cath Occlusion Normal Saline Heparin Lock	Drug: Normal Saline Flush 20 ml Drug: Normal Saline Flush 10 ml Drug: Heparin Flush (1000 USP, 10ml)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

192 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Normal saline 20 ml	Drug: Normal Saline Flush 20 ml Normal Saline Flush 20 ml
Experimental: Normal saline 10 ml	Drug: Normal Saline Flush 10 ml Normal Saline Flush 10 ml
Active Comparator: usual care (heparin)	Drug: Heparin Flush (1000 USP, 10ml) Heparin Flush (1000 USP, 10ml)

Arm

Intervention/Treatment

Experimental: Normal saline 20 ml

Drug: Normal Saline Flush 20 ml

Normal Saline Flush 20 ml

Experimental: Normal saline 10 ml

Drug: Normal Saline Flush 10 ml

Normal Saline Flush 10 ml

Active Comparator: usual care (heparin)

Drug: Heparin Flush (1000 USP, 10ml)

Heparin Flush (1000 USP, 10ml)

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chang Gung Memorial Hospital

ClinicalTrials.gov Identifier:

NCT05707936

Other Study ID Numbers:

CMRPVVM0141

First Posted:

Feb 1, 2023

Last Update Posted:

Feb 1, 2023

Last Verified:

Oct 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Flushing

Heparin

Study Results

No Results Posted as of Feb 1, 2023