Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000477820
Ethics application status
Approved
Date submitted
13/04/2012
Date registered
1/05/2012
Date last updated
1/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Subcutaneous Frusemide in patients with heart failure
Scientific title
The Use of Continuous Subcutaneous Frusemide in Decompensated Heart Failure: can it achieve a diuresis?
Secondary ID [1] 280376 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Decompensated Heart Failure 286286 0
Condition category
Condition code
Cardiovascular 286519 286519 0 0
Coronary heart disease
Cardiovascular 286642 286642 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 284676 0
Treatment: Drugs
Comparator / control treatment
No control - feasibility study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286948 0
Net urine volume voided
Timepoint [1] 286948 0
24 hours
Primary outcome [2] 286949 0
Urine sodium concentration
Timepoint [2] 286949 0
24 hours
Primary outcome [3] 286950 0
Time to first void
Timepoint [3] 286950 0
Measured from commencement of infusion
Secondary outcome [1] 297044 0
Site reactions
Timepoint [1] 297044 0
4 hourly until end of treatment period at 48 hours- using Organisational Wide Phlebitis Scale
(RCN,2005)
Secondary outcome [2] 297045 0
creatinine- serum assay
Timepoint [2] 297045 0
Daily for 4 days
Secondary outcome [3] 297046 0
length of hospital stay, number of days out of hospital
Timepoint [3] 297046 0
data linkage to medical records to 3 months post discharge

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cardiovascular instability, inotropes, and/or BiPAP, Creatinine >250umol/L

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Non randomised feasibility study.
Patients will be identified from Cardiology ward.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Open, non-randomised, prospective feasiblity study
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 4259 0
New Zealand
State/province [1] 4259 0

Funding & Sponsors
Funding source category [1] 285095 0
Self funded/Unfunded
Name [1] 285095 0
Country [1] 285095 0
New Zealand
Primary sponsor type
Hospital
Name
Auckland City Hospital
Address
Department of Cardiology
Level 3
Auckland City Hospital
Park Rd Grafton
Auckland1030
Country
New Zealand
Secondary sponsor category [1] 283955 0
University
Name [1] 283955 0
University of Auckland
Address [1] 283955 0
Associate Professor Robyn Dixon
Director of Postgraduate Studies
School of Nursing
University of Auckland
Park Rd Grafton
Auckland1030
Country [1] 283955 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287109 0
Northern X Regional Ethics Committee
Ethics committee address [1] 287109 0
Private Bag 92522
Wellesley Street
Auckland 1141
Ethics committee country [1] 287109 0
New Zealand
Date submitted for ethics approval [1] 287109 0
Approval date [1] 287109 0
08/03/2012
Ethics approval number [1] 287109 0
NTX/12/02/001

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34063 0
Address 34063 0
Country 34063 0
Phone 34063 0
Fax 34063 0
Email 34063 0
Contact person for public queries
Name 17310 0
Jane Hannah
Address 17310 0
Department of Cardiology
Level 3
Auckland City Hospital
Park Rd Grafton
Auckland 1030
Country 17310 0
New Zealand
Phone 17310 0
+ 64 9 3074949
Fax 17310 0
+64 9 3074950
Email 17310 0
[email protected]
Contact person for scientific queries
Name 8238 0
Dr James Pemberton
Address 8238 0
Cardiologist
Department of Cardiology
Level 3
Auckland City Hospital
Park Rd Grafton
Auckland 1030
Country 8238 0
New Zealand
Phone 8238 0
+64 9 3074949
Fax 8238 0
+64 9 3074950
Email 8238 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.