VAsopressin vs Noradrenaline as Initial therapy in Septic sHock: a double-blind factorial (2x2) randomised controlled trial

Imperial College London (UK)0 sites412 target enrollmentSeptember 20, 2012

Overview

Registry

who.int

Start Date

September 20, 2012

End Date

February 28, 2015

Last Updated

7 years ago

Study Type

Interventional

Sex

All

Sponsor

Imperial College London (UK)

•The target population is adult patients who require vasopressors for the management of sepsis despite fluid resuscitation.
•All patients who are clinically judged to have septic shock will be screened against the specific inclusion and exclusion criteria and these criteria will be recorded in the eCRF.
•Inclusion criteria will use the internationally\-established consensus definitions of sepsis. In brief:
•1\. Fulfil 2/4 of the criteria of the systemic inflammatory response syndrome (SIRS) due to known or suspected infection vwithin the previous 24 hours. The SIRS criteria are:
•1\.1\. Fever (\>38 C) or hypothermia (\< 36 C)
•1\.2\. Tachycardia (heart rate \> 90 beats per minute)
•1\.3\. Tachypnoea (respiratory rate \> 20 breaths per minute or PaCO2 \< 4\.3 kPa) or need for mechanical ventilation
•1\.4\. Abnormal leukocyte count (\> 12,000 cells/mm3, \< 4000 cells/mm3, or \> 10% immature \[band] forms)
•2\. Hypotension despite adequate intravenous fluid resuscitation
•3\. Male \& Female, lower age limit 16 years

•1\. Patient has received a continuous infusion of vasopressors previously during this ICU admission. Vasopressors include noradrenaline, adrenaline, vasopressin, dopamine, metaraminol, phenylephrine, and (intermittent) terlipressin
•2\. Regular systemic corticosteroid therapy within the previous three months (this does not include inhaled steroid therapy)
•3\. Known adrenal dysfunction / insufficiency
•4\. End\-stage renal failure (i.e. requiring long term dialysis)
•5\. Physician and team are not committed to full active care
•6\. Patient is known to be pregnant
•7\. Patient has known acute mesenteric ischaemia
•8\. Patient is known to have Raynaud's phenomenon, systemic sclerosis or other vasospastic diseases
•9\. Patient has been enrolled in another clinical trial of an investigational medicinal product within 30 days or is enrolled in another investigational study that might interact with the study drugs
•10\. Patient has a history of anaphylaxis to any study drug