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

Not Applicable

Recruiting

• Conditions: shock; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12621000721808
• Lead Sponsor: Caboolture Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-09
• Last Update Posted: 10 July 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary feasibility outcome will be a composite of the following:<br>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<br>Randomisation rate (target rate is 4 patients per month) determined by review of recruitment log<br>Randomisation:Eligibility ratio (target 0.80) determined by review of recruitment log[Monthly from the date of recruitment of first patient];Days alive and out of hospital up to day 60 (DAH60)[Day 60 after randomisation]

Secondary Outcome Measures

Name	Time	Method
Complications related to CVC and PIVC (local, regional or systemic) as determined by review of patient medical records<br><br>[daily until discharge from ICU];Number of peripheral venous punctures and PIVC’s by review of patient medical records[daily until off vasopressor infusion];Line-associate bloodstream infection by review of patient medical records[daily until discharge from ICU];Number of central lines inserted 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.]