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

NCT02854254 | Unknown DMC

• 1 other identifier: INCOR /2012
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

phlebitis; catheter; congestive heart failure; dobutamine

Outcome Measures

Primary Outcomes (1)

• phlebitis by visual infusion phlebitis scale (Infusion Nurses Society)

  clinically diagnosed phlebitis by visual infusion phlebitis scale (Infusion Nurses Society) with photographic register

  10 days

Study Arms (2)

PICC

EXPERIMENTAL

peripherally inserted central catheter

Device: peripherally inserted central catheter

Control

OTHER

peripherally venous access

Device: peripherally venous access

Interventions

peripherally inserted central catheter DEVICE

peripherally inserted central catheter

PICC

peripherally venous access DEVICE

standard over-the-needle intravenous catheter

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Advanced congestive heart failure
• In use of intravenous inotropic
• Platelets \> 50.000 mm3
• Left ventricular ejection fraction \< 0.45

You may not qualify if:

• Cardiac pacemaker or implantable defibrillator
• Active uncontrolled systemic infection
• Skin disease, central venous catheter

Sponsors & Collaborators

• InCor Heart Institute: lead

Study Sites (1)

Heart Institute (InCor), University of São Paulo

São Paulo, São Paulo, 05403-900, Brazil

Location

MeSH Terms

Conditions

Heart Failure; Phlebitis

Interventions

Catheterization, Peripheral

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Vascular Diseases; Vasculitis

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Antonio CP Barretto, Ph.D.

  Heart Institute (InCor), University of São Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 27, 2016
• First Posted: August 3, 2016
• Study Start: December 1, 2012
• Primary Completion: October 1, 2014
• Last Updated: August 3, 2016

Record last verified: 2016-07

Locations

BR (1)