Subcutaneous Frusemide in patients with heart failure

The Use of Continuous Subcutaneous Frusemide in Decompensated Heart Failure: can it achieve a diuresis?

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000477820

Enrollment

Registered

2012-05-01

Start date

2012-05-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The proposed study is a single centre, prospective, feasibility study measuring the effectiveness of continuous sc Frusemide (CSI-F) in achieving a diuresis in patients with decompensated heart failure.Eligible patients with decompensated heart failure who are admitted to Auckland City Hospital will be treated for the first 24 hours with usual therapy (as per Consultant Cardiologist). After 24 hours of usual care, and after obtaining informed consent, patients will receive Frusemide via a continuous subcutaneous infusion.A Safe-T Intima sc cannula will be inserted with an aseptic technique under the skin by the researcher or patients nurse. The infusion dosage will run as per Consultants medical orders via a Niki T34 syringe driver. The dose of Frusemide will be decided by the Cardiology Consultant responsible for the patients care, and will usually be dose for dose that which would be administered IV. Baseline recordings will be taken such as blood pressure (BP), heart rate (HR), respiratory rate (RR), temperature and weight will be taken prior to infusion.Primary outcome measures will be of net urine volume voided, urine sodium concentration, time to first void, weight, breathlessness and peripheral oedema score.Secondary outcome measures will be serum creatinine, site reactions, length of hospital stay, and number of days out of hospital.

Interventions

Frusemide will be administered subcutaneously through a Safe - T intima cannula continuously via a Niki syringe driver. Hourly Frusemide dose will be determined by the treating Cardiologist ( 10-20mg/hour). Length of intervention will be 48hours.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Decompensated heart failure as meaured by 2 or more of the following - increasing weight, shortness of breath, orthopnoea, paroxysmal nocturnal dyspnoea, pulmonary rales, elevated JVP, peripheral and/or abdominal oedema

Exclusion criteria

Cardiovascular instability, inotropes, and/or BiPAP, Creatinine >250umol/L

Outcome results