A randomised controlled trial of VAsopressin versus norepinephrine in Septic Shock

Not Applicable

Completed

• Conditions: Septic Shock; Infections and Infestations; Septicaemia

• Registration Number: ISRCTN94845869
• Lead Sponsor: niversity of British Columbia (Canada)

Brief Summary

2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18305265 2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/19841897 2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20606409 2011 resutls in: http://www.ncbi.nlm.nih.gov/pubmed/21892977 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22518026 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23796235 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23786655 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29958734 (added 01/10/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2003-01-31
• Study Start: 2005-08-09
• Last Update Posted: 29 October 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 776

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)

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified