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Slow Continuous Ultrafiltration Using Central vs Peripheral Line: Feasibility of Implementation, Safety and Efficacy in Acute Heart Failure Syndromes.

P

Parc de Salut Mar

Status

Unknown

Conditions

Heart Failure

Treatments

Procedure: Peripheral line
Procedure: Central line vein

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

33 participants in 2 patient groups, including a placebo group

Peripheral acces
Experimental group
Treatment:
Procedure: Peripheral line
Central access
Placebo Comparator group
Treatment:
Procedure: Central line vein

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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