VAsopressin vs Noradrenaline as Initial therapy in Septic sHock

Not Applicable

Completed

• Conditions: Topic: Infection, Generic Health Relevance and Cross Cutting Themes; Subtopic: Infection (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Infectious diseases and microbiology , Critical Care; Signs and Symptoms; Systemic Inflammatory Response Syndrome of infectious origin with organ failure

• Registration Number: ISRCTN20769191
• Lead Sponsor: Imperial College London (UK)

Brief Summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24993769 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30365341 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30538005

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-20
• Study Completion: 2015-02-28
• Last Update Posted: 14 January 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 412

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 (< 36 C)
1.2. Tachycardia (heart rate > 90 beats per minute)
1.3. Tachypnoea (respiratory rate > 20 breaths per minute or PaCO2 < 4.3 kPa) or need for mechanical ventilation
1.4. Abnormal leukocyte count (> 12,000 cells/mm3, < 4000 cells/mm3, or > 10% immature [band] forms)
2. Hypotension despite adequate intravenous fluid resuscitation
3. Male & Female, lower age limit 16 years

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified