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

Not Applicable

Completed

• Conditions: Coronary heart disease and diabetes; Circulatory System; Chronic ischaemic heart disease

• Registration Number: ISRCTN02159606
• Lead Sponsor: niversity Hospitals Bristol NHS Foundation Trust (UK)

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-29
• Study Completion: 2014-08-31
• Last Update Posted: 29 October 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 169

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%

Study & Design

• Study Type: Interventional
• Study Design: Not specified