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Clinical Trials/ISRCTN04386758
ISRCTN04386758
Completed
N/A

Optimisation of peri-operative cardiovascular management to improve surgical outcome: open randomised controlled multi-centre trial

Barts and The London School of Medicine and Dentistry, Queen Mary's University of London (UK)0 sites734 target enrollmentJuly 24, 2009
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ConditionsPost-operative complicationsInjury, Occupational Diseases, PoisoningComplications of procedures, not elsewhere classified

Overview

Phase
N/A
Intervention
Not specified
Conditions
Post-operative complications
Sponsor
Barts and The London School of Medicine and Dentistry, Queen Mary's University of London (UK)
Enrollment
734
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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)

Registry
who.int
Start Date
July 24, 2009
End Date
May 18, 2013
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Barts and The London School of Medicine and Dentistry, Queen Mary's University of London (UK)

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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