Heart FailureNCT01630317
Slow Continuous Ultrafiltration Using Central vs Peripheral Line: Feasibility of Implementation, Safety and Efficacy in Acute Heart Failure Syndromes.
A study testing Peripheral line and Central line vein in people with Heart Failure, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
Slow continuous ultrafiltration using central vs peripheral line: feasibility of implementation, safety and efficacy in acute heart failure syndromes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Peripheral line and Central line vein
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2011to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
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- 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.
Who cannot join
- 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%
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- Prior administration of IV vasoactive drugs in the emergency room (ER)
- Clinical instability requiring pressors during hospitalization
- Sepsis
- On or requires renal dialysis.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Cardiology Service, Hospital del Mar. Passeig Maritim 25-29,
Barcelona, Barcelona, 08003
About this study
Slow continuous ultrafiltration using central vs peripheral line: feasibility of implementation, safety and efficacy in acute heart failure syndromes.
- Conditions
- Heart Failure
- Being tested
- Peripheral line, Central line vein
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral lineProcedure or surgery
Ultrafiltration therapy though peripheral line, two peripheral venous catheter will be placed in the arms.
Central line veinProcedure or surgery
Ultrafiltration therapy through central line, a central venous catheter will be placed in internal jugular or femoral vein.
| Study group | Role | What they receive |
|---|---|---|
| Peripheral acces | Experimental | Not described Receives: Procedure: Peripheral line |
| Central access | Placebo comparator | Not described Receives: Procedure: Central line vein |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours after initiation of scuf therapy
Secondary outcomes (1)
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.
Measured: 5th day of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startNov 2011
- Primary completionOct 2013
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuria Ribas, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630317
- Sponsor's protocol ID
- ULISES
- Status last verified
- Apr 2016
- First submitted
- 21 Jun 2012
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Slow Continuous Ultrafiltration Using Central vs Peripheral Line: Feasibility of Implementation, Safety and Efficacy in Acute Heart Failure Syndromes.
- ClinicalTrials.gov ID
- NCT01630317
- Acronym / sponsor ID
- ULISES
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 28 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Slow continuous ultrafiltration using central vs peripheral line: feasibility of implementation, safety and efficacy in acute heart failure syndromes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peripheral acces | Experimental | Procedure: Peripheral line |
| Central access | Placebo comparator | Procedure: Central line vein |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ≥ 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral lineUltrafiltration therapy though peripheral line, two peripheral venous catheter will be placed in the arms. | Procedure or surgery | Peripheral acces |
| Central line veinUltrafiltration therapy through central line, a central venous catheter will be placed in internal jugular or femoral vein. | Procedure or surgery | Central access |
Primary outcome
Efficacy
Time frame: 48 hours after initiation of scuf therapy
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
1 secondary outcome
Security
Time frame: 5th day of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral line and Central line vein in people with Heart Failure, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: 48 hours after initiation of scuf therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2016.