A randomised controlled trial of VAsopressin versus norepinephrine in Septic Shock

ISRCTN	ISRCTN94845869
DOI	https://doi.org/10.1186/ISRCTN94845869
Secondary identifying numbers	MCT-44152

Submission date: 02/11/2004
Registration date: 09/08/2005
Last edited: 01/10/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr James Andrew Russell
Scientific

St Paul's Hospital
Rm 240 Comox Building
1081 Burrard Street
Vancouver
V6Z 1Y6
Canada

Phone	+1 604 806 2872
Email	jrussell@mrl.ubc.ca

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	A randomised controlled trial of VAsopressin versus norepinephrine in Septic Shock
Study acronym	VASST
Study objectives	To examine the effect of vasopressin versus norepinephrine in treatment of septic shock.
Ethics approval(s)	University of British Columbia/Providence Health Care (UBC/PHC) Research Ethics Board, 17/11/1999
Health condition(s) or problem(s) studied	Septic Shock
Intervention	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.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Vasopressin, norepinephrine
Primary outcome measure	28-day survival
Secondary outcome measures	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
Overall study start date	01/06/2001
Completion date	31/01/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	16 Years
Sex	Both
Target number of participants	776
Key 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)
Key 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 raynaud's phenomenon, systemic sclerosis or vasopastic diathesis 10. Traumatic brain injury (Glasgow Coma Score [GCS] less than 8 prior to onset of sepsis)
Date of first enrolment	01/06/2001
Date of final enrolment	31/01/2003

Locations

Countries of recruitment

Canada

Study participating centre

St Paul's Hospital

Vancouver
V6Z 1Y6
Canada

Sponsor information

University of British Columbia (Canada)
University/education

2075 Wesbrook Mall
Vancouver
V6T 1Z1
Canada

Phone	+1 604 822 2454
Email	customerservice@finance.ubc.ca
"ROR"	https://ror.org/03rmrcq20

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-44152)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	28/02/2008		Yes	No
Results article	results	01/01/2010		Yes	No
Results article	results	01/01/2010		Yes	No
Other publications	resutls	11/08/2011		Yes	No
Results article	results	01/09/2012		Yes	No
Results article	results	20/06/2013		Yes	No
Results article	results	01/08/2013		Yes	No
Results article	results	01/10/2018	01/10/2019	Yes	No

Editorial Notes

01/10/2019: Publication reference added.