Back to resultsSlow Continuous Ultrafiltration Using Central vs Peripheral Line: Feasibility of Implementation, Safety and Efficacy in Acute Heart Failure Syndromes.
Primary Purpose
Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Peripheral line
Central line vein
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- ≥ 18 years
- Patients hospitalized with primary diagnosis of acute heart failure defined as ≥ 2 of the following criteria:
- Peripheral or sacral edema
- Jugular venous distension or venous central pressure > 10 mmHg
- Hepatomegaly or ascites
- Pulmonary edema or pleural effusion on x-ray or pulmonary wedge pressure or end-diastolic pressure > 20 mmHg.
- High pro-BNP
- Randomization during first 24 hours
- Serum creatinine levels < 3mg/dL, and K < 6 mmol/L
- The patient should be able to communicate with research staff and meet with study procedures.
- The patient will signed informed consent.
Exclusion Criteria:
- Diagnosis of severe aortic stenosis or severe obstruction to the LVOT, tamponade, cardiac hypertrophic or restrictive cardiomyopathy.
- Impossibility of venous catheterization
- Acute coronary syndrome
- Creatinine greater than 3.0 or K greater than 6 mmol/L.
- Systolic blood pressure less than or equal to 100 mmHg
- Hematocrit greater than 45%
- Prior administration of IV vasoactive drugs in the emergency room (ER)
- Clinical instability requiring pressors during hospitalization
- Sepsis
- On or requires renal dialysis.
Sites / Locations
- Cardiology Service, Hospital del Mar. Passeig Maritim 25-29,
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Peripheral acces
Central access
Arm Description
Outcomes
Primary Outcome Measures
Efficacy
Compare patient global improvement 48 hours after initiation of scuf therapy in a group of patients with the same features treated by peripheral access against a group of patients with the same features treated by central access. This outcome will be measured by patient global assessment
Secondary Outcome Measures
Security
Compare complications in acute heart failure patients treated with scuf, in a group treated by peripheral line vs central line. This outcome will be assessed by a safety score at the AE at the 5th day of the study. ( 0 : no AE and 79 understood as the worse punctuation for the AE). Every AE has a punctuation related to the seriousness.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01630317
Brief Title
Slow Continuous Ultrafiltration Using Central vs Peripheral Line: Feasibility of Implementation, Safety and Efficacy in Acute Heart Failure Syndromes.
Official Title
Slow Continuous Ultrafiltration Using Central vs Peripheral Line: Feasibility of Implementation, Safety and Efficacy in Acute Heart Failure Syndromes.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parc de Salut Mar
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Slow continuous ultrafiltration using central vs peripheral line: feasibility of implementation, safety and efficacy in acute heart failure syndromes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peripheral acces
Arm Type
Experimental
Arm Title
Central access
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Peripheral line
Intervention Description
Ultrafiltration therapy though peripheral line, two peripheral venous catheter will be placed in the arms.
Intervention Type
Procedure
Intervention Name(s)
Central line vein
Intervention Description
Ultrafiltration therapy through central line, a central venous catheter will be placed in internal jugular or femoral vein.
Primary Outcome Measure Information:
Title
Efficacy
Description
Compare patient global improvement 48 hours after initiation of scuf therapy in a group of patients with the same features treated by peripheral access against a group of patients with the same features treated by central access. This outcome will be measured by patient global assessment
Time Frame
48 hours after initiation of scuf therapy
Secondary Outcome Measure Information:
Title
Security
Description
Compare complications in acute heart failure patients treated with scuf, in a group treated by peripheral line vs central line. This outcome will be assessed by a safety score at the AE at the 5th day of the study. ( 0 : no AE and 79 understood as the worse punctuation for the AE). Every AE has a punctuation related to the seriousness.
Time Frame
5th day of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 18 years
Patients hospitalized with primary diagnosis of acute heart failure defined as ≥ 2 of the following criteria:
Peripheral or sacral edema
Jugular venous distension or venous central pressure > 10 mmHg
Hepatomegaly or ascites
Pulmonary edema or pleural effusion on x-ray or pulmonary wedge pressure or end-diastolic pressure > 20 mmHg.
High pro-BNP
Randomization during first 24 hours
Serum creatinine levels < 3mg/dL, and K < 6 mmol/L
The patient should be able to communicate with research staff and meet with study procedures.
The patient will signed informed consent.
Exclusion Criteria:
Diagnosis of severe aortic stenosis or severe obstruction to the LVOT, tamponade, cardiac hypertrophic or restrictive cardiomyopathy.
Impossibility of venous catheterization
Acute coronary syndrome
Creatinine greater than 3.0 or K greater than 6 mmol/L.
Systolic blood pressure less than or equal to 100 mmHg
Hematocrit greater than 45%
Prior administration of IV vasoactive drugs in the emergency room (ER)
Clinical instability requiring pressors during hospitalization
Sepsis
On or requires renal dialysis.
Facility Information:
Facility Name
Cardiology Service, Hospital del Mar. Passeig Maritim 25-29,
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
12. IPD Sharing Statement
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Slow Continuous Ultrafiltration Using Central vs Peripheral Line: Feasibility of Implementation, Safety and Efficacy in Acute Heart Failure Syndromes.
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