Microvascular Imaging During Abdominal Surgery (MIDAS)
| ISRCTN | ISRCTN21597243 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21597243 |
| Secondary identifying numbers | 10093 |
- Submission date
- 25/07/2012
- Registration date
- 26/07/2012
- Last edited
- 21/09/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Gary Minto
Scientific
Scientific
Department of Anaesthesia
Derriford Hospital
Derriford Road
Crownhill
Plymouth
PL6 8DH
United Kingdom
Study information
| Study design | Randomised interventional single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Does intra-operative goal directed fluid therapy (GDT) alter microvascular circulation and reduce clinically important post-operative complications in patients undergoing elective major abdominal surgery? |
| Study acronym | MIDAS |
| Study hypothesis | RCT of algorithm driven intraoperative goal directed vs standard fluid therapy during major rectal and urological surgery. Uncalibrated pulse power analysis (LiDCO rapid) used to quantify nomincal cardiac stroke volume. Prior to surgery patients separated into aerobically fit and unfit strata by performance on cardiopulmonary exercise test. clinical outcome is Day 5 POMS (complications ) score. Perioperative microcirculatory changes also |
| Ethics approval(s) | ref: 10/H0203/68 |
| Condition | Anaesthetics |
| Intervention | Goal directed fluid therapy, supplementary gelatin colloid boluses delivered by investigator according to algorithm based on stroke volume variablity and stroke volume as shown by LiDCO rapid; Follow Up Length: 3 month(s) |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Profile of Mood States (POMS) score measured at Day 5 |
| Secondary outcome measures | Microvascular indices measured at baseline, post induction,end operative and on day 1 post operative |
| Overall study start date | 03/03/2011 |
| Overall study end date | 03/03/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | UK Sample Size: 220; Description: web based minimisation used to stratify participants according to aerobic fitness and operation type (open or lap assisted rectal ) & major urology |
| Participant inclusion criteria | 1. Patients having Rectal Resections or cystectomy 2. Male & female participants 3. Lower age limit = 18 years |
| Participant exclusion criteria | Absolute: Unwillingness to participate Inability to perform the tests and consent within the timetable for elective surgery Withdrawn by anaesthetist or surgeon Requirement by the attending anaesthetist to use cardiac output monitoring based on clinical need Acute myocardial infarction (3-5 days) Unstable angina Uncontrolled arrhythmias causing symptoms or haemodynamic compromise Syncope Active endocarditis Acute myocarditis or pericarditis Symptomatic severe aortic stenosis Uncontrolled heart failure Acute pulmonary embolus or pulmonary infarction Thrombosis of lower extremities Suspected dissecting aneurysm Uncontrolled asthma Pulmonary edema Room air desaturation at rest < 85%* Respiratory failure Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e. infection, renal failure, thyrotoxicosis) Relative: Left main coronary stenosis or its equivalent Moderate stenotic valvular heart disease Severe untreated arterial hypertension at rest (200 mm Hg systolic, 120 mm Hg diastolic) Tachyarrhythmias or bradyarrhythmias Highdegree atrioventricular block Hypertrophic cardiomyopathy Significant pulmonary hypertension Advanced or complicated pregnancy Electrolyte abnormalities Orthopaedic impairment that compromises exercise performance |
| Recruitment start date | 03/03/2011 |
| Recruitment end date | 03/03/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Derriford Hospital
Plymouth
PL6 8DH
United Kingdom
PL6 8DH
United Kingdom
Sponsor information
Plymouth Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Derriford Hospital
Derriford Road
Crownhill
Plymouth
PL6 8DH
England
United Kingdom
| Website | http://www.plymouthhospitals.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/05x3jck08 |
Funders
Funder type
Research organisation
National Institute of Academic Anaesthesia (UK)
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 | 01/10/2015 | Yes | No |
