Overview

This trial is active, not recruiting.

Condition heart failure
Treatments peripheral line, central line vein
Sponsor Parc de Salut Mar
Start date November 2011
End date October 2013
Trial size 33 participants
Trial identifier NCT01630317, ULISES

Summary

Slow continuous ultrafiltration using central vs peripheral line: feasibility of implementation, safety and efficacy in acute heart failure syndromes.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
peripheral line
Ultrafiltration therapy though peripheral line, two peripheral venous catheter will be placed in the arms.
(Placebo Comparator)
central line vein
Ultrafiltration therapy through central line, a central venous catheter will be placed in internal jugular or femoral vein.

Primary Outcomes

Measure
Efficacy
time frame: 48 hours after initiation of scuf therapy

Secondary Outcomes

Measure
Security
time frame: 5th day of the study

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Slow Continuous Ultrafiltration Using Central vs Peripheral Line: Feasibility of Implementation, Safety and Efficacy in Acute Heart Failure Syndromes.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Parc de Salut Mar.