RESUMEN
BACKGROUND: Peripheral intravenous catheters are widely used for infusion therapy. To prevent phlebitis, routine catheter replacement at 72 or 96 hours remains widely practiced. OBJECTIVE: To investigate the non-inferiority of clinically indicated peripheral intravenous catheter replacement compared with routine replacement every 96 hours to prevent phlebitis. Phlebitis severity, catheter indwelling time, and other catheter failure types were also compared. SETTING: Multi-center trial in wards at two hospitals in Sao Paulo, Brazil. DESIGN: The REplacement of PEripheral intravenous CaTheters according to clinical signs or every 96 hours (RESPECT) trial was a Randomized, non-blinded, controlled, non-inferiority trial. PARTICIPANTS: 1319 patients were enrolled with the following inclusion criteria: aged ≥18 years, expected peripheral intravenous therapy for ≥96 hours; peripheral intravenous catheters inserted in the selected wards, intensive care units, or surgical centers; and informed consent provided. Exclusion criteria were: bloodstream infection and/or sepsis, neutrophil count of ≤1000/mm3, and simultaneous use of more than one peripheral intravenous catheter. Recruitment occurred within 96 hours of peripheral intravenous catheter insertion. Randomization was performed using a computer-generated, concealed list. METHODS: As intervention, clinically indicated replacement group patients underwent peripheral intravenous catheter removal only at the end of therapy or in the presence of phlebitis, infiltration, occlusion, displacement, accidental removal, or bloodstream infection. Routine 96-h replacement group patients (control) had their catheters replaced every 96-h, unless clinical reasons required earlier replacement. The primary outcome was Phlebitis and the analyses were carried out on intention-to-treat and per-protocol bases. RESULTS: Demographic and clinical variables were similar between groups, with the exception to type of admission (p = 0.025) more frequent in clinically indicated patients and surgical on routine replacement group. Of the 1319 patients, 119 (9.0%) developed phlebitis with no between-group difference (p = 0.162); these patients used 2747 peripheral intravenous catheters, being that 134 presented phlebitis. Phlebitis/1000 catheter-days, was 14.9 in the clinically indicated group and 23.8 in the routine replacement group (p = 0.006). The survival analysis showed no significant between-group difference in the occurrence of the first phlebitis episode. CONCLUSIONS: Clinically indicated peripheral intravenous catheter replacement was not inferior to routine (96 hours) replacement regarding phlebitis occurrence, and was associated with significantly less phlebitis per 1000 days. TRIAL REGISTRATION: Registered with www.clinicaltrials.gov (NCT02568670).