None listed
Conditions
Brief summary
Vasopressor infusions are an essential for management of circulatory shock and are traditionally administered via CVC, though administration via PIVC has also been described. Whether delivery of vasopressor via PIVC is comparable in terms of safety and efficacy to delivery via CVC is currently unknown. We hypothesize that administration of vasopressor medications via PIVC over a short duration, in controlled doses and with appropriate monitoring is safe and effective compared to that via central venous catheter in terms of patient outcomes. This pilot phase 2 study will enroll 40 patients (20 in each group) who are admitted with shock needing vasopressor infusions. Eligible patients will be identified, and once consent is obtained they will be randomized to either an early (short duration of vasopressors via PIVC) or late (longer duration of vasopressors via PIVC) CVC group. The primary endpoints of the study will be feasibility of the protocol and days alive and out of hospital at day 60.
Interventions
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 medical practice. A VPI includes any of the following medications – Noradrenaline, Adrenaline, Metaraminol, Phenylephrine and Vasopressin.
Sponsors
Study design
Eligibility
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
Exclusion criteria
* Pregnancy or suspected pregnancy * Treating clinician believes that survival beyond 48 hours is unlikely or patient being admitted to ICU solely for Palliation or Organ Donation * Has received vasopressor infusion for 4 hours * Requiring >0.1mcg/kg/min noradrenaline (or equivalent dose of other vasopressors) at the time of screening; or requiring >1 vasopressor agent * Patient already has a CVC in-situ or requires a CVC insertion for specific therapies other than vasopressors (e.g., total parenteral nutrition, severe electrolyte derangements like: K+ less than or equal to 2.0 mmol/L, PO4-2 less than or equal to 0.3 mmol/L, or for Ca+2 infusion for CRRT)