Condition category
Surgery
Date applied
25/07/2012
Date assigned
26/07/2012
Last edited
21/09/2015
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 Gary Minto

ORCID ID

Contact details

Department of Anaesthesia
Derriford Hospital
Derriford Road
Crownhill
Plymouth
PL6 8DH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10093

Study information

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?

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

ref: 10/H0203/68

Study design

Randomised interventional single-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

03/03/2011

Overall trial end date

03/03/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients having Rectal Resections or cystectomy
2. Male & female participants
3. Lower age limit = 18 years

Participant type

Patient

Age group

Adult

Gender

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 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

United Kingdom

Trial participating centre

Derriford Hospital
Plymouth
PL6 8DH
United Kingdom

Sponsor information

Organisation

Plymouth Hospitals NHS Trust (UK)

Sponsor details

Derriford Hospital
Derriford Road
Crownhill
Plymouth
PL6 8DH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.plymouthhospitals.nhs.uk/

Funders

Funder type

Research organisation

Funder name

National Institute of Academic Anaesthesia (UK)

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26385666

Publication citations

Additional files

Editorial Notes