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

NCT ID: NCT05707936

Last Updated: 2023-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Port-a-cath Occlusion Normal Saline Heparin Lock

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Normal saline 20 ml

Group Type EXPERIMENTAL

Normal Saline Flush 20 ml

Intervention Type DRUG

Normal Saline Flush 20 ml

Normal saline 10 ml

Group Type EXPERIMENTAL

Normal Saline Flush 10 ml

Intervention Type DRUG

Normal Saline Flush 10 ml

usual care (heparin)

Group Type ACTIVE_COMPARATOR

Heparin Flush (1000 USP, 10ml)

Intervention Type DRUG

Heparin Flush (1000 USP, 10ml)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Normal Saline Flush 20 ml

Normal Saline Flush 20 ml

Intervention Type DRUG

Normal Saline Flush 10 ml

Normal Saline Flush 10 ml

Intervention Type DRUG

Heparin Flush (1000 USP, 10ml)

Heparin Flush (1000 USP, 10ml)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CMRPVVM0141

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Fluids in Septic Shock (FISSH)
NCT03677102 RECRUITING PHASE2/PHASE3