Topic: Infection, Generic Health Relevance and Cross Cutting Themes
Conditions
Interventions
1. Vasopressin vs. Noradrenaline as initial vasopressor therapy and then
2. Intravenous hydrocortisone vs. placebo
Hydrocortisone, 50mg 6 hourly
Noradr
Sponsors
Imperial College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 ( 90 beats per minute) 1.3. Tachypnoea (respiratory rate > 20 breaths per minute or PaCO2 12,000 cells/mm3, 10% immature [band] forms) 2. Hypotension despite adequate intravenous fluid resuscitation 3. Male & Female, lower age limit 16 years
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Renal failure free days at day 28 post randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rates and duration of renal replacement therapy 2. Length of renal failure in survivors and non-survivors 3. 28-day, ICU and hospital mortality rates 4. Organ failure free days in the first 28 days, assessed using the serial organ failure assessment (SOFA) score 5. Organ support data assessed using the standard NHS Healthcare Resource Groups 6. Blood, plasma and urinary biomarkers of renal function and inflammation (including genetic polymorphisms) | — |
Countries
United Kingdom
Outcome results
None listed