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Trial record 7 of 243 for:    furosemide

Subcutaneous Furosemide in Acute Decompensated Heart Failure Pilot (SUBQ-Pilot)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02877095
Recruitment Status : Completed
First Posted : August 24, 2016
Results First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Adrian Hernandez, Duke University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Heart Failure
Intervention Drug: Furosemide
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title In-patient Pilot Out-patient Pilot Study
Hide Arm/Group Description

All subjects in the in-patient study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.

Furosemide: subcutaneous furosemide delivered via subcutaneous pump

All subjects in the out-patient study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.

Furosemide: subcutaneous furosemide delivered via subcutaneous pump

Period Title: Overall Study
Started 20 [1] 20
Completed 20 20
Not Completed 0 0
[1]
First patient enrolled 1/9/17.
Arm/Group Title In-patient Pilot Study Out-patient Pilot Study Total
Hide Arm/Group Description

All subjects in the in-patient pilot study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.

Furosemide: subcutaneous furosemide delivered via subcutaneous pump

All subjects in the out-patient study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.

Furosemide: subcutaneous furosemide delivered via subcutaneous pump

Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
68.2  (14.6) 57.8  (12.0) 63.0  (14.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
8
  40.0%
4
  20.0%
12
  30.0%
Male
12
  60.0%
16
  80.0%
28
  70.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Hispanic or Latino
0
   0.0%
1
   5.0%
1
   2.5%
Not Hispanic or Latino
20
 100.0%
19
  95.0%
39
  97.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  30.0%
4
  20.0%
10
  25.0%
White
14
  70.0%
16
  80.0%
30
  75.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 40 participants
20 20 40
1.Primary Outcome
Title Overall Safety of a Strategy Based on Subcutaneous Delivery of Furosemide in Inpatients and Outpatients as Measured by Number of Adverse Events
Hide Description The analysis of data from the Pilot Phase will be primarily descriptive in nature and there will be no formal hypothesis testing. Number of patients with events will be reported.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title In-patient Pilot Out-patient Pilot Study
Hide Arm/Group Description:

All subjects in the pilot study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.

Furosemide: subcutaneous furosemide delivered via subcutaneous pump

All subjects in the pilot study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.

Furosemide: subcutaneous furosemide delivered via subcutaneous pump

Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: participants
Patients with any Adverse Events 4 9
Patients with no Events 16 11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection In-patient Pilot
Comments All subjects on study received active drug.
Type of Statistical Test Other
Comments [Not Specified]
Other Statistical Analysis Total count of events is provided.
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title In-patient Pilot Study Out-patient Pilot Study
Hide Arm/Group Description

All subjects in the in-patient study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.

Furosemide: subcutaneous furosemide delivered via subcutaneous pump

All subjects in the out-patient study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.

Furosemide: subcutaneous furosemide delivered via subcutaneous pump

All-Cause Mortality
In-patient Pilot Study Out-patient Pilot Study
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)      0/20 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
In-patient Pilot Study Out-patient Pilot Study
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      1/20 (5.00%)    
Infections and infestations     
Implant site infection * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
1
Term from vocabulary, Meddra
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
In-patient Pilot Study Out-patient Pilot Study
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/20 (20.00%)      8/20 (40.00%)    
Cardiac disorders     
Cardiac Failure * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
General disorders     
Injection Site Pain * 1  2/20 (10.00%)  2 2/20 (10.00%)  2
Injection Site discomfort * 1  1/20 (5.00%)  1 1/20 (5.00%)  1
Injection site erythema * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Injection site haemorhage * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Injection Site Rash * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Injury, poisoning and procedural complications     
Contusion * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Fall * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Procedural haemorrhage * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Musculoskeletal and connective tissue disorders     
Muscle spasm * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Psychiatric disorders     
Nervousness * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders     
Cough * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Dyspnoea * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
epistaxis * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Skin and subcutaneous tissue disorders     
Erythema * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Skin irritation  1  0/20 (0.00%)  0 1/20 (5.00%)  1
1
Term from vocabulary, MedRA
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Rachel Olson, Project Leader
Organization: Duke Clinical Research Institute
Phone: 919-309-5544
EMail: rachel.e.olson@duke.edu
Layout table for additonal information
Responsible Party: Adrian Hernandez, Duke University
ClinicalTrials.gov Identifier: NCT02877095     History of Changes
Other Study ID Numbers: Pro00070399
First Submitted: August 15, 2016
First Posted: August 24, 2016
Results First Submitted: November 29, 2018
Results First Posted: March 15, 2019
Last Update Posted: March 15, 2019