Optimisation of peri-operative cardiovascular management to improve surgical outcome

Not Applicable

Completed

• Conditions: Post-operative complications; Injury, Occupational Diseases, Poisoning; Complications of procedures, not elsewhere classified

• Registration Number: ISRCTN04386758
• Lead Sponsor: Barts and The London School of Medicine and Dentistry, Queen Mary's University of London (UK)

Brief Summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24842135 2019 results in: http://www.ncbi.nlm.nih.gov/pubmed/30850406 (added 11/03/2019) 2019 substudy results in: https://www.ncbi.nlm.nih.gov/pubmed/31633603 (added 22/10/2019) 2019 analysis in https://www.ncbi.nlm.nih.gov/pubmed/30850406 (added 31/03/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-24
• Study Completion: 2013-05-18
• Last Update Posted: 20 April 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 734

Inclusion Criteria

Adult patients undergoing major abdominal surgery involving the gastrointestinal tract which is expected to take longer than 90 minutes are eligible for recruitment provided they satisfy one of the following additional criteria:
1. Urgent or emergency surgery
2. Acute or chronic renal impairment
3. Diabetes mellitus
4. Aged 65 years and older, either sex
5. Presence of a risk factor for cardiac or respiratory disease

Exclusion Criteria

Current exclusion criteria as of 03/05/2012
1. Patients receiving palliative treatment only
2. Acute myocardial ischaemia at time of enrolment
3. Pulmonary oedema at time of enrolment
4. Moderate/severe thromocytopenia (platelet count <50 x 109/l)
5. Patients receiving monoamine oxidase inhibitors (MAOIs)
6. Phaechromocytoma
7. Severe left ventricular outlet obstruction, e.g. hypertrophic obstructive cardiomyopathy or severe aortic stenosis
8. Known hypersensitivity to dopexamine hydrochloride or disodium edenate
9. Pregnancy
10. Septic shock

Previous exclusion criteria
1. Patients receiving palliative treatment only
2. Acute myocardial ischaemia at time of enrolment
3. Pulmonary oedema at time of enrolment
4. Moderate/severe thromocytopenia
5. Patients receiving monoamine oxidase inhibitors (MAOIs)
6. Phaechromocytoma
7. Severe left ventricular outlet obstruction, e.g. hypertrophic obstructive cardiomyopathy or severe aortic stenosis
8. Known hypersensitivity to dopexamine hydrochloride or disodium edenate
9. Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measure(s):<br> Difference in the number of patients developing post-operative complications or dying within 30 days following randomisation between study groups.<br><br> Previous primary outcome measure(s):<br> Difference in 28 days post-mortality between study groups.<br>