Vasopressor Infusion via Peripheral vs Central Access in patients with shock.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2021
INTERVENTION: Common treatment applied to both groups The VPI will be initiated via the PIVC in both groups at a time chosen by the treating clinician as per standard practice (it is standard practice for all patients with shock to have at least one PIVC inserted as soon as possible in Australian Emergency Departments) All other treatments for the underlying condition that has necessitated VPI (such as antibiotics, source control procedures, fluid therapy) will be at the discretion of the treating clinician Peripheral Vasopressor group (Late Central group) – usual care (as defined below) plus: Peripheral Intravenous Canula (PIVC), 18‐gauge preferred Delayed insertion of central venous line (CVC) – A CVC is not to be inserted for at least 12 hours from randomisation. A CVC can be inserted earlier than 12 hours if required for the following reasons: Noradrenaline‐equivalent dose greater than or equal to 0.2mcg/kg/min Need for irritant medications/infusions that cannot be administered via a PIVC Failure of drug delivery via PIVC Complications of PIVC including extravasation of Vasopressor Infusion (VPI), or tissue necrosis The PIVC/CVC will be inserted by ED or ICU doctors and monitored by ED and ICU nurses The insertion of the PIVC is anticipated to take 5 minutes, delayed insertion of the CVC is anticipated to take approximately 20 minutes Early Central VPI group ‐ usual care plus Patients in the Early Central group will have a CVC inserted within 4 hours of randomisation Usual care includes: a combination of cardiopulmonary resuscitation, fluid resuscitation, vasopressors given as bolus &/or infusion, source control including surgical intervention, antibiotics as well as investigations etc. and in accordance with standard CONDITION: Cardiovascular ‐ Diseases of the vasculature and circulation including the lymphatic system shock; ; shock PRIMARY OUTCOME: Days alive and out of hospital up to day 60 (DAH60)[Day 60 after randomisation] Primary feasibility outcome will be a composite of the following:; Protocol adherence (time to central line insertion in both groups; adherence to all aspects of trial protocol) as determined from audit of hospital medical records; Randomisation rate (target rate is 4 patients per month) determined by review of recruitment log; Randomisation:Eligibility ratio (target 0.80) determined by review of recruitment log[Monthly from the date of recruitment of first patient] SECONDARY OUTCOME: Complications related to CVC and PIVC (local, regional or systemic) as determined by review of patient medical records ; ; [daily until discharge from ICU] Line‐associate bloodstream infection by review of patient medical records[daily until discharge from ICU] Missing data will be assessed by an audit of the entire study database by the trial statistician[Assessed once after the conclusion of day 60 assessment for the last enrolled patient.] Number of central lines inserted by review of patient medical records[Daily Until discharge from ICU] Number of peripheral venous punctures and PIVC’s by review of patient medical records[daily until off vasopressor infusion] INCLUSION CRITERIA: * Patients admitted to Caboolture Hospital ED * Any unplanned admission to Caboolture Hospital ICU * greater than 18 years * Treating clinician has deemed that a Vasopressor Infusion is required
Epistemonikos ID: 9a95eedbf7a626f14f5627720eccd4052261398d
First added on: Aug 25, 2024