Non-invasive, bedside assessment of systemic endothelial function: a predictor of mortality in intensive care?
| ISRCTN | ISRCTN49531007 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49531007 |
| Secondary identifying numbers | RGHT000413 |
- Submission date
- 19/05/2009
- Registration date
- 05/06/2009
- Last edited
- 29/01/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Brian Mullan
Scientific
Scientific
Regional Intensive Care Unit
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
Study information
| Study design | Prospective observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Function of the Endothelium in Critical Care: a prospective observational cohort study |
| Study acronym | FECC |
| Study objectives | Bedside assessment of systemic endothelial function using non-invasive pulse wave analysis (PWA) predicts outcome in intensive care. |
| Ethics approval(s) | Northern Ireland HPSS REC 3 approved on the 21st June 2007 (ref: 07/NIR03/30) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/07/2007 |
| Completion date | 01/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 182 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/07/2007 |
| Date of final enrolment | 01/12/2009 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
Regional Intensive Care Unit
Belfast
BT12 6BA
United Kingdom
BT12 6BA
United Kingdom
Sponsor information
Royal Victoria Hospital (UK)
Hospital/treatment centre
Hospital/treatment centre
Grosvenor Road
Belfast
BT12 6BA
Northern Ireland
United Kingdom
| Phone | +44(0)28 9024 0503 |
|---|---|
| mary.williams@belfasttrust.hscni.net | |
| Website | http://www.belfasttrust.hscni.net |
"ROR" |
https://ror.org/03rq50d77 |
Funders
Funder type
Research organisation
Royal College of Anaesthetists/British Journal of Anaesthesia (UK) - Grant (2008)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2011 | Yes | No |
