1AHMED BENTRIDI,1Patrick Gilbert, 1Patrick Gilbert, 1AHMED BENTRIDI, 1Vincent Oliva, 1Vincent Oliva, 1LOUIS BOUCHARD, 1CHOUNARD A, 1BERNIER C,
To test the hypothesis that Midlines are non-inferior to PICC for intravenous therapy that does not require a central catheter.
Material(s) and Method(s):
Vascular Plug insertion and bProspective randomized open-label clinical trial, in which Midlines are compared to PICCs in adults who required peripheral intravenous therapy of 1-4 weeks. With a noninferiority margin of 10%, 510 patients need to be enrolled in this study. Patients eligible for Midline according to recommendations of the Infusion Nurses Society (2016) were included. Vesicant intravenous therapy was excluded. Patients were followed until one week after venous access removal. The primary efficacy outcome was the percentage of patients who completed their treatment without limitation due to catheter dysfunction.
This interim analysis includes the first 72 patients enrolled (45 men, 27 women; average age: 52,6 years) since August 2018, 35 randomized to the Midline group and 37 to the PICC group. One catheter was removed prematurely in both groups (P=0,78). Catheter dysfunction, mostly incapacity to draw blood, was observed in 6/35 (21%) patients in the Midline group versus 1/36 (2,8%) patients in the PICCs group (p=0,01). There were 3/35 (8,5%) device-related adverse events in midline group and no adverse event in PICCs (p=0,46), There was one unrelated death in the PICC group and no major device-related event in both groups
Comparison of primary efficacy outcomes with available data is not yet conclusive. However, given the greater catheter dysfunction rate with Midlines, these catheters should not replace PICC in patients with difficult venipuncture and who require blood samplings.