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A randomised controlled trial of VAsopressin versus norepinephrine in Septic Shock
DOI 10.1186/ISRCTN94845869
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised controlled trial of VAsopressin versus norepinephrine in Septic Shock
Scientific title
Acronym VASST
Serial number at source MCT-44152
Study hypothesis To examine the effect of vasopressin versus norepinephrine in treatment of septic shock.
Lay summary Not provided at time of registration
Ethics approval Ethics approval received from the University of British Columbia/Providence Health Care (UBC/PHC) Research Ethics Board on the 17th November 1999
Study design Randomised controlled trial
Countries of recruitment Canada
Disease/condition/study domain Septic Shock
Participants - inclusion criteria 1. 776 adult patients with septic shock of either sex, 16 years and older
2. Aged greater than 16 years
3. Evidence of severe septic shock as defined by criteria listed below:
3.1. Systemic Inflammatory Response (SIRS), presence of two or more of the following:
3.1.1. Fever (temperature greater than 38°C/hypothermia less than 36°C)
3.1.2. Tachycardia (heart rate greater than 90 beats per minute)
3.1.3. Tachypnea (respiratory rate greater than 20 breaths per minute or PaCO2 32 torr or mechanically ventilated)
3.1.4. Pathologic white blood cell count (greater than 12,000 cells/mm^3, less than 4000 cells/mm^3, or greater than 10% immature band forms)
3.2. Known (culture positive) or suspected (cultures pending, patient on antibiotics) source of infection (defines sepsis)
3.3. Evidence of one new organ dysfunction (defines severe sepsis):
3.3.1. Lung (ventilated and partial pressure of oxygen in arterial blood [PaO2]/fraction of inspired oxygen [FiO2]) less than 300
3.3.2. Renal (urine output less than 30 ml/hour or less than 0.5 ml/kg body weight, for at least 1 hour)
3.3.3. Coagulation (platelet count less than 80,000/mm^3)
3.3.4. Central nervous system (CNS) (Glasgow coma scale less than 12)
3.4. Hypotension and need for vasopressors (defines severe septic shock):
3.4.1. Systolic blood pressure (SBP) less than 90 mmHg or decrease in SBP by at least 40 mmHg for more then one hour while central venous pressures remain adequate (greater than or equal to 12 mmHg) or at least 500 ml of saline was infused. Duration of hypotension may be less than one hour if vasopressors are infused to maintain blood pressure, and requirement for vasopressor support (norepinephrine equivalent) = (dopamine ÷ 2 µg/kg/min) + norepinephrine (µg/min) + epinephrine (µg/min) + phenylephrine ÷ 20 (µg/min) greater than or equal to 5 µg/min for at least six consecutive hours in the last 24 hours and on at least 5 µg/min within the last hour prior to randomisation, or severe septic shock: vasopressor support (norepinephrine equivalent, as above) greater than or equal to 15 µg/min in the last hour prior to randomisation
4. Central venous catheter (pulmonary-arterial catheter is optional)
Participants - exclusion criteria 1. Physician and team are not committed to aggressive care
2. Patient who is terminal (death anticipated in 12 months)
3. Greater than 24 hours have elapsed since the patient met entry criteria
4. Patient is pregnant (Pregnancy test required in all women less than 50 years)
5. Underlying chronic heart disease (New York Heart Association [NYHA] class III or IV) and shock
6. Unstable angina or myocardial infarction manifest by chest pain and S-T segment elevation within the previous 30 days
7. Acute mesenteric ischemia present or suspected
8. Severe hyponatremia (Na less than 130 mmol/l)
9. Patient has raynaudís phenomenon, systemic sclerosis or vasopastic diathesis
10. Traumatic brain injury (Glasgow Coma Score [GCS] less than 8 prior to onset of sepsis)
Anticipated start date 01/06/2001
Anticipated end date 31/01/2003
Status of trial Completed
Patient information material
Target number of participants 776
Interventions Patient will be randomised in a blinded fashion to receive a continuous infusion of either vasopressin (experimental therapy) or norepinephrine (control therapy). The study infusion will be used as the primary means of stabilising and maintaining a patient's blood pressure.
Primary outcome measure(s) 28-day survival
Secondary outcome measure(s) 1. 90-day survival
2. Organ failure free days
3. Days alive and free of shock
4. Days alive and free of SIRS
5. Days alive and free of steroid use
6. Length of stay in the Intensive Care Units (ICU)
7. Length of stay in hospital
8. Effects on biologic markers of inflammation
9. Effect on haemodynamic variables
Sources of funding Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-44152)
Trial website
Publications 1. 2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18305265
2. 2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/19841897
3. 2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20606409
4. 2011 resutls in: http://www.ncbi.nlm.nih.gov/pubmed/21892977
5. 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22518026
6. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23796235
Contact name Dr  James Andrew  Russell
  Address St Paul's Hospital
Rm 240 Comox Building
1081 Burrard Street
  City/town Vancouver
  Zip/Postcode V6Z 1Y6
  Country Canada
  Tel +1 604 806 2872
  Fax +1 604 806 8599
  Email jrussell@mrl.ubc.ca
Sponsor University of British Columbia (Canada)
  Address 2075 Wesbrook Mall
  City/town Vancouver
  Zip/Postcode V6T 1Z1
  Country Canada
  Tel +1 604 822 2454
  Email customerservice@finance.ubc.ca
Date applied 02/11/2004
Last edited 25/10/2013
Date ISRCTN assigned 09/08/2005
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