Condition category
Signs and Symptoms
Date applied
03/06/2010
Date assigned
10/09/2010
Last edited
16/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anthony Gordon

ORCID ID

Contact details

Clinical Senior Lecturer & Consultant
Critical Care Medicine
11N
Imperial College/Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
-
anthony.gordon@imperial.ac.uk

Additional identifiers

EudraCT number

2009-017636-41

ClinicalTrials.gov number

Protocol/serial number

UKCRN ID: 8828; EudraCT: 2009-017636-41

Study information

Scientific title

Vasopressin and Corticosteroids in septic Shock: an open-label randomised controlled trial

Acronym

VACS

Study hypothesis

This is an open-label randomised controlled trial. It will be conducted in the three general adult ICUs within the Imperial College Healthcare NHS Trust. All patients will be treated with vasopressin as the initial vasopressor therapy to maintain mean arterial blood pressure after adequate fluid resuscitation. If maximum doses of vasopressin are reached the patient will be treated with the randomised study drug (hydrocortisone or placebo), before additional clinically indicated vasopressors/inotropes are prescribed.

The objectives of this trial are:
1. To assess if corticosteroids increase exogenously administered vasopressin levels in septic shock
2. To assess if corticosteroids increase the blood pressure response to exogenously administered vasopressin
3. To act as feasibility study for a larger double-blind randomised controlled trial

As of 22/11/2011 the overalltrial end date has been updated. The previous date was 30/09/2011.

Ethics approval

Oxford REC A, 18/05/2010, ref: 10/H0604/35

Study design

Open-label randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Critical Care

Intervention

Vasopressin +/- steroids; the two treatment arms will be:
1. Vasopressin (0 - 0.06 U/minute via continuous intravenous [IV] infusion) and hydrocortisone sodium phosphate (50 mg IV 6-hourly)
2. Vasopressin (0 - 0.06 U/minute via continuous IV infusion) and placebo (0.5 ml 0.9% saline IV 6 hourly)

Vasopressin will continue until shock has resolved. Hydrocortisone will continue for a maximum of 11 days. Total follow-up is 28 days.

Study entry: single randomisation only

Intervention type

Drug

Phase

Not Applicable

Drug names

Vasopressin, hydrocortisone

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

30/08/2010

Overall trial end date

31/03/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 60; UK sample size: 60

Participant 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

Recruitment start date

30/08/2010

Recruitment end date

31/03/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Imperial College/Charing Cross Hospital
London
W6 8RF
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

c/o Gary Roper
Joint Research Office
Sir Alexander Fleming Building
Exhibition Road
London
SW7 2AZ
United Kingdom
+44 (0)20 7594 1188
gary.roper@imperial.ac.uk

Sponsor type

University/education

Website

http://www3.imperial.ac.uk/clinicalresearchgovernanceoffice

Funders

Funder type

Government

Funder name

Intensive Care Foundation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24557425

Publication citations

Additional files

Editorial Notes