Condition category
Haematological Disorders
Date applied
19/05/2009
Date assigned
05/06/2009
Last edited
29/01/2013
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 Brian Mullan

ORCID ID

Contact details

Regional Intensive Care Unit
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom

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 SphygmoCorâ„¢ 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

http://www.belfasttrust.hscni.net

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

  1. 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.

Additional files

Editorial Notes