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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Peripherally Inserted Central Catheters (PICC) Reduce Phlebitis Incidence in Heart Failure Patients Receiving Prolonged Intravenous Inotropic Infusion: a Randomized Trial.

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.

Detailed Summary:

Study design To evaluate the incidence of phlebitis using the PICC compared to peripheral venous access a randomized clinical trial was conducted in the period between 12/07/2012 and 10/02/2014, in adult cardiology department of a university hospital in Brazil. Patients were randomized into two groups permuted blocks of four. The sequence of randomization was built with random allocation blocks 4 through of random number tables. (3).The primary endpoint was occurrence of phlebitis.

Population Patients who were admitted with congestive heart failure of decompensated in use of intravenous inotropic agents were screened for eligibility to participate in this study. Inclusion criteria were: advanced congestive heart failure, use of vasoactive drugs, patients with platelet ≥50.000 mm3, left ventricular ejection fraction <0.45, upper limb venous system able for catheter insertion and central catheter peripherally inserted. Exclusion criteria were age <18, cardiac pacemaker or defibrillator, active systemic infection without treatment or without control, platelets <50.000 mm3, injury skin in cubital region and presence of central catheter.

Sample size calculation Based on pilot study data, we estimated the occurrence of phlebitis 20% in PICC group and 80% in control group. Considering statistical power of 80% and α-error in 5%, the sample size was estimated by 39 patients in each group. For more conservative estimation we defined 40 patients in each group (80 patients in total).Considering these values the sample size was 39 patients in each group in a more conservative estimate set the size in 40 patients for each group and 60% in the control group and 20% in the PICC group. In total 172 patients were evaluated, of these 86 patients did not meet the inclusion criteria and six did not agree to participate.

Sponsor: InCor Heart Institute

Current Primary Outcome: phlebitis by visual infusion phlebitis scale (Infusion Nurses Society) [ Time Frame: 10 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: InCor Heart Institute

Dates:
Date Received: July 27, 2016
Date Started: December 2012
Date Completion:
Last Updated: July 29, 2016
Last Verified: July 2016