Postoperative Basal Bolus or Sliding Scale Insulin Regimen in DM2 and Its Effect on Surgical Site Infections.

Официальное название

Postoperative Glucose Control with a Basal Bolus Versus Sliding Scale Insulin Regimen and Its Effect on the Incidence of Surgical Site Infections in People with Type 2 Diabetes Mellitus.

Обзор

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.

Подробное описание

People with type 2 diabetes mellitus (PWT2D) are at increased risk of postoperative complications, especially surgical site infections (SSI).

The aim of this study to reduce SSI in PWT2D by implementing a proactive basal-bolus insulin regimen, compared to the reactive sliding scale regimen.

Adult patients with type 2 diabetes will be included in this multi-centre study.

Participants will receive a blind CGM, i.e. glucose data are masked for the participants and study team, from admission to the ward until discharge from the hospital. In addition, all participants are asked to complete several questionnaires 30 days after surgery.

Both regimens are currently used in clinical practice. Therefore, there is no additional trial-related burden depending on the intervention group allocation.

Participants will be monitored intensively and insulin dosage will be adjusted adequately to the measured glucose values by the treatment team.

The sample size is based on the SSI incidence rates. Wards are matched into pairs with comparable baseline incidence rates and in each pair, one ward will be randomly assigned to the intervention group; the other serves as the control. 18 wards from 8 participating centres are planned to be recruited, this translates to 9x2x56=1008 evaluable participants.

Keywords:

Diabetes mellitus, basal bolus, sliding scale, insulin regimen, surgical site infections

Вмешательства

• Другое Basal bolus insulin regimen
  Combination of long-acting and short-acting insulin in a proactive schedule for achieving better blood glucose values postoperatively

Первичные конечные точки

• Surgical site infection [Срок оценки: Until 30 days after surgery]

Вторичные конечные точки (12)

• Postoperative hospital-acquired infections (non-SSI) [Срок оценки: Recorded at 30 days postoperatively]
• Length of stay in the hospital (LoS-Hos) [Срок оценки: Recorded at 30 days postoperatively]
• Hospital readmission [Срок оценки: Recorded 30 days postoperatively]
• Days at home (DAH30) [Срок оценки: Recorded 30 days postoperatively]
• Postoperative disability [Срок оценки: Recorded 30 days postoperatively]
• Quality of life (QoL) after surgery [Срок оценки: Recorded 30 days postoperatively]
• Glucose 2 [Срок оценки: Measured 4 times a day, until discharge from the hospital, up to 30 days.]
• Glucose 3 [Срок оценки: Measured 4 times a day, until discharge from the hospital, up to 30 days.]
• Glucose 4 [Срок оценки: Measured 4 times a day, until discharge from the hospital, up to 30 days.]
• CGM1 [Срок оценки: Measured with a 5-minute interval, until discharge from the hospital, up to 30 days.]
• CGM2 [Срок оценки: Measured with a 5-minute interval, until discharge from the hospital, up to 30 days.]
• CGM3 [Срок оценки: Measured with a 5-minute interval, until discharge from the hospital, up to 30 days.]

Критерии участия

Критерии включения

• Patients aged 18 or older
• Diagnosed with type 2 diabetes mellitus
• Undergoing gastointestinal or vascular surgery
• Admitted to one of the participating surgical wards
• Expected duration of stay at least one overnight stay
• Willing and able to provide informed consent

Критерии исключения

• Diagnosed with type 1 diabetes mellitus
• Female of child-bearing potential who is pregnant or breastfeeding.
• Undergoing complete pancreatectomy
• Undergoing bariatric surgery
• Patients using a continuous insulin pump at home
• Patients undergoing a necrotectomy/wound debridement from a pre-existent wound.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Нидерланды · 1 центр

• Amsterdam UMC — Amsterdam

Публикации

• Kao LS, Phatak UR. Glycemic control and prevention of surgical site infection. Surg Infect (Larchmt). 2013 Oct;14(5):437-44. doi: 10.1089/sur.2013.008. Epub 2013 Oct 10. PMID 24111757
• Kotagal M, Symons RG, Hirsch IB, Umpierrez GE, Dellinger EP, Farrokhi ET, Flum DR; SCOAP-CERTAIN Collaborative. Perioperative hyperglycemia and risk of adverse events among patients with and without diabetes. Ann Surg. 2015 Jan;261(1):97-103. doi: 10.1097/SLA.0000000000000688. PMID 25133932
• Polderman JA, Van Velzen L, Wasmoeth LG, Eshuis JH, Houweling PL, Hollmann MW, Devries JH, Preckel B, Hermanides J. Hyperglycemia and ambulatory surgery. Minerva Anestesiol. 2015 Sep;81(9):951-9. Epub 2015 Jan 16. PMID 25592489
• de Vries FE, Gans SL, Solomkin JS, Allegranzi B, Egger M, Dellinger EP, Boermeester MA. Meta-analysis of lower perioperative blood glucose target levels for reduction of surgical-site infection. Br J Surg. 2017 Jan;104(2):e95-e105. doi: 10.1002/bjs.10424. Epub 2016 Nov 30. PMID 27901264
• Umpierrez GE, Smiley D, Jacobs S, Peng L, Temponi A, Mulligan P, Umpierrez D, Newton C, Olson D, Rizzo M. Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes undergoing general surgery (RABBIT 2 surgery). Diabetes Care. 2011 Feb;34(2):256-61. doi: 10.2337/dc10-1407. Epub 2011 Jan 12. PMID 21228246
• de Lissovoy G, Fraeman K, Hutchins V, Murphy D, Song D, Vaughn BB. Surgical site infection: incidence and impact on hospital utilization and treatment costs. Am J Infect Control. 2009 Jun;37(5):387-397. doi: 10.1016/j.ajic.2008.12.010. Epub 2009 Apr 23. PMID 19398246
• Phillips VL, Byrd AL, Adeel S, Peng L, Smiley DD, Umpierrez GE. A Comparison of Inpatient Cost Per Day in General Surgery Patients with Type 2 Diabetes Treated with Basal-Bolus versus Sliding Scale Insulin Regimens. Pharmacoecon Open. 2017;1(2):109-115. doi: 10.1007/s41669-017-0020-9. Epub 2017 Apr 21. PMID 28660256
• Koek MBG, van der Kooi TII, Stigter FCA, de Boer PT, de Gier B, Hopmans TEM, de Greeff SC; Burden of SSI Study Group. Burden of surgical site infections in the Netherlands: cost analyses and disability-adjusted life years. J Hosp Infect. 2019 Nov;103(3):293-302. doi: 10.1016/j.jhin.2019.07.010. Epub 2019 Jul 19. PMID 31330166

Идентификаторы

NCT: NCT06638567 · GUIDE trial

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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