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Clinical Trials/ISRCTN02159606
ISRCTN02159606
Completed
未知

Pre-operative volume replacement versus usual care in diabetic patients having coronary artery bypass graft (CABG) surgery: a randomised controlled trial

niversity Hospitals Bristol NHS Foundation Trust (UK)0 sites169 target enrollmentOctober 29, 2008

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity Hospitals Bristol NHS Foundation Trust (UK)
Enrollment
169
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

  1. 2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28630035 2. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31539025 (added 23/09/2019)
Registry
who.int
Start Date
October 29, 2008
End Date
August 31, 2014
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity Hospitals Bristol NHS Foundation Trust (UK)

Eligibility Criteria

Inclusion Criteria

  • Current inclusion criteria as of 15/05/2009:
  • 1\. Patients with diagnosed type I or type II diabetes, being treated with oral medication and/or insulin (i.e. not diet controlled only)
  • 2\. Both males and females, age \>16 and \<80 years
  • 3\. Undergoing elective or urgent, isolated first time coronary artery bypass graft (CABG) with or without cardiopulmonary bypass (CPB)
  • 4\. Left ventricular ejection fraction \>\=30%
  • Previous inclusion criteria:
  • 1\. Patients with diagnosed type I or type II diabetes
  • 2\. Both males and females, aged greater than 16 and less than 80 years
  • 3\. Undergoing elective or urgent, isolated first time coronary artery bypass graft (CABG) with or without cardiopulmonary bypass (CPB)
  • 4\. Left ventricular ejection fraction greater than or equal to 25%

Exclusion Criteria

  • 1\. Patients who have had previous cardiac surgery
  • 2\. Emergency or salvage operation
  • 3\. Chronic renal failure requiring dialysis
  • 4\. Current congestive heart failure
  • 5\. Left ventricular ejection fraction \<30% (i.e. poor LV function)
  • Please note that the 5th exclusion criterion was updated as of 15/05/2009\. The previous criterion was as follows:
  • 5\. Left ventricular ejection fraction less than 25%

Outcomes

Primary Outcomes

Not specified

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