Safety and Efficacy of Midline vs Peripherally Inserted Central Catheters Among Adults Receiving IV Therapy: A Randomized Clinical Trial.

Importance: Midline catheters (MCs) are widely used, but safety and efficacy compared with peripherally inserted central catheters (PICCs) has not been adequately evaluated. Objective: To compare the safety and efficacy of MCs with PICCs among adult patients with an anticipated intravenous therapy lasting from 5 to 28 days. Design, Setting, and Participants: This parallel, 2-group, open-label, randomized clinical trial (RCT) was conducted in Denmark from October 2018 to February 2022 at a single academic tertiary care center. Adult inpatients and outpatients were consecutively randomized. Intervention: Patients were randomized in a 1:1 ratio to either the MC group or the PICC control group. Main Outcomes and Measures: The primary outcome was catheter-related bloodstream infection (CRBSI), analyzed using the Fisher exact test. Secondary outcomes were symptomatic catheter-related thrombosis and catheter failure, including mechanical cause, phlebitis, infiltration, pain in relation to drug or fluid administration, and leaking from the puncture site. Incidence rate ratios (IRRs) were calculated to assess between-group failure rates over device dwell time using Poisson regression. An intention-to-treat analysis was performed. Results: A total of 304 patients (mean [SD] age, 64.6 [13.5] years; 130 [42.8%] female) were included in the analysis, and 152 patients were allocated to each catheter group. The incidence of CRBSI was low, with 0 in the MC group and 1 in the PICC control group (P > .99). The MC group had a higher catheter-related complication rate (20 [13.2%] vs 11 [7.2%]), and an IRR of 2.37 (95% CI, 1.12-5.02; P = .02) for complications compared with the PICC control group. In a post hoc analysis stratified by catheter dwell time, no significant difference in complication rate (IRR, 1.16; 95% CI, 0.50-2.68; P = .73) was found between the 2 groups for catheters used less than 16 days. Conclusions and Relevance: In this RCT with patients who received medium- to long-term intravenous therapy, the incidence of CRBSI was low, with no difference between MCs and PICCs. The use of MCs resulted in a higher incidence of catheter-related complications compared with use of PICCs. This finding should be balanced in the decision of type of catheter used at the individual patient level. Trial Registration: ClinicalTrials.gov Identifier: NCT04140916.

Restricting volumes of resuscitation fluid in adults with septic shock after initial management: the CLASSIC randomised, parallel-group, multicentre feasibility trial.

PURPOSE: We assessed the effects of a protocol restricting resuscitation fluid vs. a standard care protocol after initial resuscitation in intensive care unit (ICU) patients with septic shock. METHODS: We randomised 151 adult patients with septic shock who had received initial fluid resuscitation in nine Scandinavian ICUs. In the fluid restriction group fluid boluses were permitted only if signs of severe hypoperfusion occurred, while in the standard care group fluid boluses were permitted as long as circulation continued to improve. RESULTS: The co-primary outcome measures, resuscitation fluid volumes at day 5 and during ICU stay, were lower in the fluid restriction group than in the standard care group [mean differences -1.2 L (95 % confidence interval -2.0 to -0.4); p < 0.001 and -1.4 L (-2.4 to -0.4) respectively; p < 0.001]. Neither total fluid inputs and balances nor serious adverse reactions differed statistically significantly between the groups. Major protocol violations occurred in 27/75 patients in the fluid restriction group. Ischaemic events occurred in 3/75 in the fluid restriction group vs. 9/76 in the standard care group (odds ratio 0.32; 0.08-1.27; p = 0.11), worsening of acute kidney injury in 27/73 vs. 39/72 (0.46; 0.23-0.92; p = 0.03), and death by 90 days in 25/75 vs. 31/76 (0.71; 0.36-1.40; p = 0.32). CONCLUSIONS: A protocol restricting resuscitation fluid successfully reduced volumes of resuscitation fluid compared with a standard care protocol in adult ICU patients with septic shock. The patient-centred outcomes all pointed towards benefit with fluid restriction, but our trial was not powered to show differences in these exploratory outcomes. TRIAL REGISTRATION: NCT02079402.