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Peripherally Inserted Central Catheter Use for Dobutamine Infusion in Heart Failure Patients

NCT02854254 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-08-03

No results posted yet for this study

Summary

In decompensation of heart failure, it may occur low cardiac output. For patients in this situation, the use of inotropic may be necessary. Prolonged intravenous infusion of inotropic agents can lead to phlebitis in peripherally venous access. On the other hand, central venous access presents complications inherent in the procedure. The peripherally inserted central catheter (PICC) may be an option in this situation. The present research project is a randomized clinical trial to evaluate the incidence of phlebitis by using the PICC in comparison to the peripheral venous access. The criteria for inclusion are: advanced congestive heart failure, in use of intravenous inotropic; platelets \> 50.000 mm3 and left ventricular ejection fraction (LVEF) \< 0.45. Patients will be randomized to receive the PICC or keep the peripheral venous access. The main outcome will be the occurrence of phlebitis. The sample size will be of 40 patients for each group (PICC and control). The data will be analyzed by logistic regression. Will be considered significant P 0.05.

Conditions

  • Congestive Heart Failure

Interventions

DEVICE

peripherally inserted central catheter

peripherally inserted central catheter

DEVICE

peripherally venous access

standard over-the-needle intravenous catheter

Sponsors & Collaborators

  • InCor Heart Institute

    lead OTHER

Principal Investigators

  • Antonio CP Barretto, Ph.D. · Heart Institute (InCor), University of São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-10-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02854254 on ClinicalTrials.gov