Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RGHT000413
Study information
Scientific title
Function of the Endothelium in Critical Care: a prospective observational cohort study
Acronym
FECC
Study hypothesis
Bedside assessment of systemic endothelial function using non-invasive pulse wave analysis (PWA) predicts outcome in intensive care.
Ethics approval
Northern Ireland HPSS REC 3 approved on the 21st June 2007 (ref: 07/NIR03/30)
Study design
Prospective observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Systemic endothelial function in critical care
Intervention
Recruited patients will be categorised as follows:
1. Medical
2. Surgical
3. Trauma
4. Burns
Baseline information to be recorded will include:
1. Patient demographics
2. Physiological data
3. Plasma biochemistry profile (including liver function)
4. Full blood picture and coagulation screen
5. Acute Physiology and Chronic Health Evaluation II (APACHE II) score
6. Simplified Acute Physiology Score II (SAPS II) score
7. Sequential Organ Failure Assessment (SOFA) score
All clinical data and measurements will be undertaken and recorded by the research fellow. Systemic endothelial function as measured by pulse wave analysis will be performed non-invasively using the SphygmoCor™ pulse wave analysis system (AtCor Medical Pty Ltd, Australia). In addition the following surrogate markers of endothelial function will be recorded:
1. Albumin creatinine ratio (ACR)
2. Plasma von Willebrand Factor (vWF)
3. Plasma adhesion molecules, ICAM, VCAM and E-selectin
Blood and urine samples will be taken at admission. Urinary albumin and creatinine concentrations will be measured by ELISA and colorimetric assays, respectively. Von Willebrand Factor and adhesion molecules, ICAM, VCAM, E-Selectin will be measured using an ELISA. A blood sample will be taken 20 minutes after administration of the nebulised salbutamol. This sample will be analysed for a plasma salbutamol concentration, again using ELISA. In this way systemic uptake of salbutamol will be confirmed.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Intensive Care Unit (ICU) mortality
Secondary outcome measures
1. Length of ICU stay
2. Number of ventilator days
3. Incidence of organ failures
4. Need for continuous renal replacement therapy
5. Duration of inotropic support
Overall trial start date
01/07/2007
Overall trial end date
01/12/2009
Reason abandoned
Eligibility
Participant inclusion criteria
All adult patients admitted to the regional intensive care unit at the Royal Group of Hospitals, Belfast will be eligible for inclusion in the study.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
182
Participant exclusion criteria
1. Aged less than 18 years old
2. Pregnancy
3. Inability to achieve radial arterial access
4. Known allergy or sensitivity to salbutamol or glyceryl trinitrate (GTN)
5. Patients transferred from other intensive care units
6. Patients unlikely to survive more than 24 hours
7. Patients with an advance directive regarding limitation of treatment
8. Patients who have a "Do Not Attempt Resuscitation" (DNAR) order in place
9. Lack of consent
Recruitment start date
01/07/2007
Recruitment end date
01/12/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Regional Intensive Care Unit
Belfast
BT12 6BA
United Kingdom
Sponsor information
Organisation
Royal Victoria Hospital (UK)
Sponsor details
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
+44(0)28 9024 0503
mary.williams@belfasttrust.hscni.net
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Royal College of Anaesthetists/British Journal of Anaesthesia (UK) - Grant (2008)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21242802
Publication citations
-
Results
Duffy MJ, Mullan BA, Craig TR, Shyamsundar M, MacSweeney RE, Thompson G, Stevenson M, McAuley DF, Impaired endothelium-dependent vasodilatation is a novel predictor of mortality in intensive care., Crit. Care Med., 2011, 39, 4, 629-635, doi: 10.1097/CCM.0b013e318206bc4a.