Normal Saline Versus Heparin Intermittent Flushing for th... | NCT05707936

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

NCT05707936

Sponsor

Chang Gung Memorial Hospital

Status

Unknown status

Last Update Posted

Feb 1, 2023Actual

Enrollment

192Estimated

Phase

Not Applicable

Conditions

Port-a-cath Occlusion
Normal Saline
Heparin Lock

Interventions

Normal Saline Flush 20 ml
Normal Saline Flush 10 ml
Heparin Flush (1000 USP, 10ml)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2023Estimated

Primary Completion Date

Sep 1, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Oct 28, 2022

First Submission Date that Met QC Criteria

Jan 30, 2023

First Posted Date

Feb 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2023

Last Update Posted Date

Feb 1, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

192Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Normal Saline Flush 20 ml	Drug	Normal Saline Flush 20 ml	Normal saline 20 ml

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided