|
Welcome
|
|
23 May 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| A randomised controlled trial of VAsopressin versus norepinephrine in Septic Shock |
| ISRCTN | ISRCTN94845869 |
| ClinicalTrials.gov identifier | |
| 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 | |
| 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 raynaud’s 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 |
| 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 |
| 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 |
| customerservice@finance.ubc.ca | |
| Date applied | 02/11/2004 |
| Last edited | 01/02/2011 |
| Date ISRCTN assigned | 09/08/2005 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|