Microvascular Imaging During Abdominal Surgery (MIDAS)
| ISRCTN | ISRCTN21597243 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21597243 |
| Protocol serial number | 10093 |
| Sponsor | Plymouth Hospitals NHS Trust (UK) |
| Funder | National Institute of Academic Anaesthesia (UK) |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional single-centre trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
Profile of Mood States (POMS) score measured at Day 5 |
| Key secondary outcome measure(s) |
Microvascular indices measured at baseline, post induction,end operative and on day 1 post operative |
| Completion date | 03/03/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 220 |
| Key inclusion criteria | 1. Patients having Rectal Resections or cystectomy 2. Male & female participants 3. Lower age limit = 18 years |
| Key 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 |
| Date of first enrolment | 03/03/2011 |
| Date of final enrolment | 03/03/2013 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Derriford Hospital
Plymouth
PL6 8DH
United Kingdom
PL6 8DH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
