Postoperative Basal Bolus or Sliding Scale Insulin Regimen in DM2 and Its Effect on Surgical Site Infections.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbraham Hulst, MD, PhD
About this trial
A multicentre, matched-pair, cluster randomised controlled superiority trial to investigate the effect of a proactive basal bolus insulin regimen compared to the reactive sliding scale insulin regimen, targeting a glucose level of 3.9-10.0 mmol/L, to reduce the number of surgical site infections within the first 30 days postoperatively in adult patients with diabetes mellitus type 2.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 or older
Diagnosed with type 2 diabetes mellitus
Undergoing gastointestinal or vascular surgery
Admitted to one of the participating surgical wards
Disqualifiers
Diagnosed with type 1 diabetes mellitus
Female of child-bearing potential who is pregnant or breastfeeding.
Undergoing complete pancreatectomy
Undergoing bariatric surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Basal bolus insulin regimen
Other interventionCombination of long-acting and short-acting insulin in a proactive schedule for achieving better blood glucose values postoperatively
Treatment groups
1,008 Participants
are divided into 2 treatment groupsGroup A: Basal BolusExperimental treatment 1 intervention
Group B: Sliding ScaleNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Surgical site infection
Incidence of postoperative surgical site infection, according to the criteria of the centres of disease control (CDC) for superficial incisional SSI, deep incisional SSI and organ / space SSI. SSIs will be measured at 30 days postoperatively via BLUEBELLE questionnaire, diagnosis by surgeon during standard postoperative visit at the surgery clinic 3-5 weeks after surgery and chart review.
Time frame
Until 30 days after surgerySecondary outcomes
1
Postoperative hospital-acquired infections (non-SSI)
Incidence of hospital-acquired infections, other than surgical site infections
Time frame
Recorded at 30 days postoperatively2
Length of stay in the hospital (LoS-Hos)
Length of stay in the hospital, measured in days from admission to discharge from the hospital.
Time frame
Recorded at 30 days postoperatively3
Hospital readmission
Rate of hospital readmissions within 30 days after surgery
Time frame
Recorded 30 days postoperatively4
Days at home (DAH30)
Patient-reported number of days at home after surgery, between 0 and 30.
Time frame
Recorded 30 days postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Abraham Hulst, MD, PhD
Lead sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor institution
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Source ClinicalTrials.gov