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Efficacy of Tight Versus Moderate Glycemic Control on the Rate of Surgical Site Infection in Patients with Diabetes Mellitus Undergoing Coronary Artery Bypass Graft (CABG) -A Single Centre Prospective Randomized Control Trial

Efficacy of Tight Versus Moderate Glycemic Control on the Rate of Surgical Site Infection in Patients with Diabetes Mellitus Undergoing Coronary Artery Bypass Graft (CABG) -A Single Centre Prospective Randomized Control Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625001420437
Acronym
TVMSSI Study
Enrollment
60
Registered
2025-12-17
Start date
2025-12-31
Completion date
2026-11-30
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary objective is to compare between tight and moderate glycemic control in reducing the rate of surgical site infection, determine the ideal range of glucose control to minimize surgical site infection and evaluate factors associated with SSI in post CABG patients. We Hypotheses that tight glycemic control reduces the rate of surgical site infection. The outcome will be reduced rate of SSI at 30 days post-surgery. Data will be analyzed using intention to treat analysis

Interventions

For the intervention - tight glycemic control This involved maintaining blood glucose levels(BGL) at 'target range' of 4.4mmol/L–6.0 mmol/L. The registered nurses(RN) cum diabetic educator will monitored the BGL in order to stabilizes within target range for two consecutive hour. if the BGL exceeds the upper limit or trends lower than desired, the RN will adjust accordingly. For example, if BGL goes below 4.4mmol/L, with rapid infusion halts if hypoglycemia (BGL <4.0 mmol/L) occurs. The mode

For the intervention - tight glycemic control This involved maintaining blood glucose levels(BGL) at 'target range' of 4.4mmol/L–6.0 mmol/L. The registered nurses(RN) cum diabetic educator will monitored the BGL in order to stabilizes within target range for two consecutive hour. if the BGL exceeds the upper limit or trends lower than desired, the RN will adjust accordingly. For example, if BGL goes below 4.4mmol/L, with rapid infusion halts if hypoglycemia (BGL <4.0 mmol/L) occurs. The mode of delivery will be insulin infusion through Intravenous (IV) line and delivered by registered nurse who will be monitoring the frequency/duration of the intervention monitoring prior to surgery and post-operatively every one to 2 hours in the cardiac critical care and recovery wards

Sponsors

Sarawak Consolidated Industries
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Elective Coronary Artery Bypass Graft (CABG) • Type 2 Diabetic • Able to provide informed consent. • Adults over the age of 18

Exclusion criteria

1. Presence of active auto-immune or immune diseases and patients with the use of systemic steroid or immunosuppresant 2. type 1 diabetic, gestational diabetes 3. patient undergoing valve replacement surgery

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026