Slow Continuous Ultrafiltration Using Central vs Peripheral Line: Feasibility of Implementation, Safety and Efficacy in Acute Heart Failure Syndromes.
1 other identifier
interventional
33
1 country
1
Brief Summary
Slow continuous ultrafiltration using central vs peripheral line: feasibility of implementation, safety and efficacy in acute heart failure syndromes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable heart-failure
Started Nov 2011
Longer than P75 for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 21, 2012
CompletedFirst Posted
Study publicly available on registry
June 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedApril 26, 2016
April 1, 2016
1.9 years
June 21, 2012
April 25, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
48 hours after initiation of scuf therapy
Secondary Outcomes (1)
Security
5th day of the study
Study Arms (2)
Peripheral acces
EXPERIMENTALCentral access
PLACEBO COMPARATORInterventions
Ultrafiltration therapy though peripheral line, two peripheral venous catheter will be placed in the arms.
Ultrafiltration therapy through central line, a central venous catheter will be placed in internal jugular or femoral vein.
Eligibility Criteria
You may qualify if:
- ≥ 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cardiology Service, Hospital del Mar. Passeig Maritim 25-29,
Barcelona, Barcelona, 08003, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Nuria Ribas
Study Record Dates
First Submitted
June 21, 2012
First Posted
June 28, 2012
Study Start
November 1, 2011
Primary Completion
October 1, 2013
Study Completion
December 1, 2016
Last Updated
April 26, 2016
Record last verified: 2016-04