Vasopressin and Corticosteroids in septic Shock

Completed

Conditions: Topic: Generic Health Relevance and Cross Cutting Themes
Subtopic: Generic Health Relevance (all Subtopics)
Disease: Critical Care
Infections and Infestations
Septic shock

Registration Number: ISRCTN66727957

Lead Sponsor: Imperial College London (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

The target population is adult patients who require vasopressors for the management of sepsis despite fluid resuscitation. These patients will require management on the intensive care unit.

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 within the previous 24 hours. The SIRS criteria are:
1.1. Fever (greater than 38°C) or hypothermia (less than 36°C)
1.2. Tachycardia (heart rate greater than 90 beats per minute)
1.3. Tachypnea (respiratory rate greater than 20 breaths per minute or partial pressure of carbon dioxide in the blood [PaCO2] less than 4.3 kPa) or need for mechanical ventilation
1.4. Abnormal leukocyte count (greater than 12,000 cells/mm3, less than 4000 cells/mm3, or greater than 10% immature [band] forms)
2. Hypotension despite adequate intravenous fluid resuscitation (minimum of 1 litre in the previous four hours)
3. Aged greater than or equal to 16 years, either sex

Exclusion Criteria

1. Patient has received a continuous infusion of vasopressors previously during this hospital admission (other than vasopressors used as emergency treatment to stabilise the patient during this episode). Vasopressors include noradrenaline, adrenaline, vasopressin, dopamine, metaraminol, phenylephrine.
2. Regular systemic corticosteroid therapy within the previous three months (this does not include inhaled steroid therapy)
3. End-stage renal failure
4. Known adrenal dysfunction/insufficiency
5. Physician and team are not committed to full active care
6. Patient who is terminally ill (death anticipated within 24 hours)
7. Patient is known to be pregnant
8. Patient has known acute mesenteric ischaemia
9. Patient is being actively treated for an acute coronary syndrome
10. Patient is known to have Raynaud's phenomenon, systemic sclerosis or other vasospastic diseases
11. Patient is enrolled in another interventional trial that might interact with the study drugs
12. Patients has a history of anaphylaxis to any study drug

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma vasopressin levels, measured 6 - 24 hours post-steroid administration

Secondary Outcome Measures

Name	Time	Method
1. Difference in vasopressin requirements between treatment groups<br>2. 28-day, ICU and hospital mortality rates<br>3. Organ failure free days in the first 28 days, assessed using the serial organ failure assessment (SOFA) score