Slow Continuous Ultrafiltration Using Central vs Peripheral Line: Feasibility of Implementation, Safety and Efficacy in Acute Heart Failure Syndromes.
This study is currently recruiting participants.
Verified June 2012 by Parc de Salut Mar
Sponsor:
Parc de Salut Mar
Information provided by (Responsible Party):
Magi Farre, Parc de Salut Mar
ClinicalTrials.gov Identifier:
NCT01630317
First received: June 21, 2012
Last updated: February 12, 2013
Last verified: June 2012
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Purpose
Slow continuous ultrafiltration using central vs peripheral line: feasibility of implementation, safety and efficacy in acute heart failure syndromes.
| Condition | Intervention |
|---|---|
|
Heart Failure |
Procedure: Peripheral line Procedure: Central line vein |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Slow Continuous Ultrafiltration Using Central vs Peripheral Line: Feasibility of Implementation, Safety and Efficacy in Acute Heart Failure Syndromes. |
Resource links provided by NLM:
Further study details as provided by Parc de Salut Mar:
Primary Outcome Measures:
- Efficacy [ Time Frame: 48 hours after initiation of scuf therapy ] [ Designated as safety issue: No ]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 [ Time Frame: 5th day of the study ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Peripheral acces |
Procedure: Peripheral line
Ultrafiltration therapy though peripheral line, two peripheral venous catheter will be placed in the arms.
|
| Placebo Comparator: Central access |
Procedure: Central line vein
Ultrafiltration therapy through central line, a central venous catheter will be placed in internal jugular or femoral vein.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630317
Contacts
| Contact: Nuria Ribas, MD | 0034 93 248 3118 | 60055@parcdesalutmar.cat |
| Contact: Cristina Enjuanes, MD | 0034 93 248 31 20 | 60448@parcdesalutmar.cat |
Locations
| Spain | |
| Cardiology Service, Hospital del Mar. Passeig Maritim 25-29, | Recruiting |
| Barcelona, Spain, 08003 | |
| Principal Investigator: Nuria Ribas, MD | |
Sponsors and Collaborators
Parc de Salut Mar
More Information
No publications provided
| Responsible Party: | Magi Farre, Nuria Ribas, Parc de Salut Mar |
| ClinicalTrials.gov Identifier: | NCT01630317 History of Changes |
| Other Study ID Numbers: | ULISES |
| Study First Received: | June 21, 2012 |
| Last Updated: | February 12, 2013 |
| Health Authority: | Spain: Comité Ético de Investigación Clínica |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013