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Review
. 2023 Aug 1;8(8):CD007315.
doi: 10.1002/14651858.CD007315.pub3.

Perioperative glycaemic control for people with diabetes undergoing surgery

Filip Bellon  1   2 , Ivan Solà  3 , Gabriel Gimenez-Perez  4   5 , Marta Hernández  6 , Maria-Inti Metzendorf  7 , Esther Rubinat #  1   2   8 , Didac Mauricio #  8   9   10
Affiliations
Review

Perioperative glycaemic control for people with diabetes undergoing surgery

Filip Bellon et al. Cochrane Database Syst Rev. .

Abstract

Background: People with diabetes mellitus are at increased risk of postoperative complications. Data from randomised clinical trials and meta-analyses point to a potential benefit of intensive glycaemic control, targeting near-normal blood glucose, in people with hyperglycaemia (with and without diabetes mellitus) being submitted for surgical procedures. However, there is limited evidence concerning this question in people with diabetes mellitus undergoing surgery.

Objectives: To assess the effects of perioperative glycaemic control for people with diabetes undergoing surgery.

Search methods: For this update, we searched the databases CENTRAL, MEDLINE, LILACS, WHO ICTRP and ClinicalTrials.gov. The date of last search for all databases was 25 July 2022. We applied no language restrictions.

Selection criteria: We included randomised controlled clinical trials (RCTs) that prespecified different targets of perioperative glycaemic control for participants with diabetes (intensive versus conventional or standard care).

Data collection and analysis: Two authors independently extracted data and assessed the risk of bias. Our primary outcomes were all-cause mortality, hypoglycaemic events and infectious complications. Secondary outcomes were cardiovascular events, renal failure, length of hospital and intensive care unit (ICU) stay, health-related quality of life, socioeconomic effects, weight gain and mean blood glucose during the intervention. We summarised studies using meta-analysis with a random-effects model and calculated the risk ratio (RR) for dichotomous outcomes and the mean difference (MD) for continuous outcomes, using a 95% confidence interval (CI), or summarised outcomes with descriptive methods. We used the GRADE approach to evaluate the certainty of the evidence (CoE).

Main results: A total of eight additional studies were added to the 12 included studies in the previous review leading to 20 RCTs included in this update. A total of 2670 participants were randomised, of which 1320 were allocated to the intensive treatment group and 1350 to the comparison group. The duration of the intervention varied from during surgery to five days postoperative. No included trial had an overall low risk of bias. Intensive glycaemic control resulted in little or no difference in all-cause mortality compared to conventional glycaemic control (130/1263 (10.3%) and 117/1288 (9.1%) events, RR 1.08, 95% CI 0.88 to 1.33; I2 = 0%; 2551 participants, 18 studies; high CoE). Hypoglycaemic events, both severe and non-severe, were mainly experienced in the intensive glycaemic control group. Intensive glycaemic control may slightly increase hypoglycaemic events compared to conventional glycaemic control (141/1184 (11.9%) and 41/1226 (3.3%) events, RR 3.36, 95% CI 1.69 to 6.67; I2 = 64%; 2410 participants, 17 studies; low CoE), as well as those considered severe events (37/927 (4.0%) and 6/969 (0.6%), RR 4.73, 95% CI 2.12 to 10.55; I2 = 0%; 1896 participants, 11 studies; low CoE). Intensive glycaemic control, compared to conventional glycaemic control, may result in little to no difference in the rate of infectious complications (160/1228 (13.0%) versus 224/1225 (18.2%) events, RR 0.75, 95% CI 0.55 to 1.04; P = 0.09; I2 = 55%; 2453 participants, 18 studies; low CoE). Analysis of the predefined secondary outcomes revealed that intensive glycaemic control may result in a decrease in cardiovascular events compared to conventional glycaemic control (107/955 (11.2%) versus 125/978 (12.7%) events, RR 0.73, 95% CI 0.55 to 0.97; P = 0.03; I2 = 44%; 1454 participants, 12 studies; low CoE). Further, intensive glycaemic control resulted in little or no difference in renal failure events compared to conventional glycaemic control (137/1029 (13.3%) and 158/1057 (14.9%), RR 0.92, 95% CI 0.69 to 1.22; P = 0.56; I2 = 38%; 2086 participants, 14 studies; low CoE). We found little to no difference between intensive glycaemic control and conventional glycaemic control in length of ICU stay (MD -0.10 days, 95% CI -0.57 to 0.38; P = 0.69; I2 = 69%; 1687 participants, 11 studies; low CoE), and length of hospital stay (MD -0.79 days, 95% CI -1.79 to 0.21; P = 0.12; I2 = 77%; 1520 participants, 12 studies; very low CoE). Due to the differences within included studies, we did not pool data for the reduction of mean blood glucose. Intensive glycaemic control resulted in a mean lowering of blood glucose, ranging from 13.42 mg/dL to 91.30 mg/dL. One trial assessed health-related quality of life in 12/37 participants in the intensive glycaemic control group, and 13/44 participants in the conventional glycaemic control group; no important difference was shown in the measured physical health composite score of the short-form 12-item health survey (SF-12). One substudy reported a cost analysis of the population of an included study showing a higher total hospital cost in the conventional glycaemic control group, USD 42,052 (32,858 to 56,421) compared to the intensive glycaemic control group, USD 40,884 (31.216 to 49,992). It is important to point out that there is relevant heterogeneity between studies for several outcomes. We identified two ongoing trials. The results of these studies could add new information in future updates on this topic.

Authors' conclusions: High-certainty evidence indicates that perioperative intensive glycaemic control in people with diabetes undergoing surgery does not reduce all-cause mortality compared to conventional glycaemic control. There is low-certainty evidence that intensive glycaemic control may reduce the risk of cardiovascular events, but cause little to no difference to the risk of infectious complications after the intervention, while it may increase the risk of hypoglycaemia. There are no clear differences between the groups for the other outcomes. There are uncertainties among the intensive and conventional groups regarding the optimal glycaemic algorithm and target blood glucose concentrations. In addition, we found poor data on health-related quality of life, socio-economic effects and weight gain. It is also relevant to underline the heterogeneity among studies regarding clinical outcomes and methodological approaches. More studies are needed that consider these factors and provide a higher quality of evidence, especially for outcomes such as hypoglycaemia and infectious complications.

Trial registration: ClinicalTrials.gov NCT00433251 NCT00995501 00370643 NCT00524472 00107601 NCT00609986 NCT00460499 NCT00220987 NCT01643382 NCT01211730 NCT00443599 NCT01565941 NCT01187329 NCT00788242 NCT01227148 https://doi.org/10.1186/s12871-019-0918-0 NCT03526536 NCT01886365 NCT00899483 NCT01528189 NCT02746432 NCT03314272 NCT034474666 NCT02032953.

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Conflict of interest statement

The authors declare that they do not have any conflicts of interest.

Figures

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Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included trials (blank cells indicate that the particular outcome was not measured in some trials).
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Risk of bias summary: review authors' judgements about each risk of bias item for each included trial (blank cells indicate that the particular outcome was not measured in some trials)
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1.1
1.1. Analysis
Comparison 1: Perioperative intensive vs conventional glycaemic control, Outcome 1: All‐cause mortality
1.2
1.2. Analysis
Comparison 1: Perioperative intensive vs conventional glycaemic control, Outcome 2: All‐cause mortality (sensitivity analysis: only published data; low risk of bias)
1.3
1.3. Analysis
Comparison 1: Perioperative intensive vs conventional glycaemic control, Outcome 3: Hypoglycaemic episodes (severe)
1.4
1.4. Analysis
Comparison 1: Perioperative intensive vs conventional glycaemic control, Outcome 4: Hypoglycaemic episodes (any)
1.5
1.5. Analysis
Comparison 1: Perioperative intensive vs conventional glycaemic control, Outcome 5: Hypoglycaemic episodes (severe; sensitivity analysis: only published data)
1.6
1.6. Analysis
Comparison 1: Perioperative intensive vs conventional glycaemic control, Outcome 6: Hypoglycaemic episodes (any; sensitivity analysis: only published data)
1.7
1.7. Analysis
Comparison 1: Perioperative intensive vs conventional glycaemic control, Outcome 7: Infectious complications
1.8
1.8. Analysis
Comparison 1: Perioperative intensive vs conventional glycaemic control, Outcome 8: Infectious complications (sensitivity analysis: only published data)
1.9
1.9. Analysis
Comparison 1: Perioperative intensive vs conventional glycaemic control, Outcome 9: Cardiovascular events
1.10
1.10. Analysis
Comparison 1: Perioperative intensive vs conventional glycaemic control, Outcome 10: Cardiovascular events (sensitivity analysis: only published data)
1.11
1.11. Analysis
Comparison 1: Perioperative intensive vs conventional glycaemic control, Outcome 11: Renal failure
1.12
1.12. Analysis
Comparison 1: Perioperative intensive vs conventional glycaemic control, Outcome 12: Renal failure (sensitivity analysis: only published data)
1.13
1.13. Analysis
Comparison 1: Perioperative intensive vs conventional glycaemic control, Outcome 13: Length of ICU stay
1.14
1.14. Analysis
Comparison 1: Perioperative intensive vs conventional glycaemic control, Outcome 14: Length of ICU stay (sensitivity analysis: only published data)
1.15
1.15. Analysis
Comparison 1: Perioperative intensive vs conventional glycaemic control, Outcome 15: Length of hospital stay
1.16
1.16. Analysis
Comparison 1: Perioperative intensive vs conventional glycaemic control, Outcome 16: Length of hospital stay (sensitivity analysis: only published data)
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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Lazar 2004 {published data only (unpublished sought but not used)}
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Lazar 2011 {published data only}
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Li 2006 {published data only (unpublished sought but not used)}
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References to studies excluded from this review

Abdelmalak 2019 {published and unpublished data}
    1. Abdelmalak BB, You J, Kurz A, Kot M, Bralliar T, Remzi FH, et al. The effects of dexamethasone, light anesthesia, and tight glucose control on postoperative fatigue and quality of life after major noncardiac surgery: a randomized trial. Journal of Clinical Anesthesia 2019;55:83-91. [DOI: ] - PubMed
Agus 2014 {published and unpublished data}
    1. NCT00443599. SPECS: safe pediatric euglycemia in cardiac surgery (SPECS). clinicaltrials.gov/ct2/show/results/NCT00443599 (first received 6 March 2007).
Agus 2017 {published and unpublished data}
    1. Agus MS, Wypij D, Hirshberg EL, Srinivasan V, Faustino EV, Luckett PM, et al, HALF-PINT Study Investigators and the PALISI Network*. Tight glycemic control in critically Ill children. New England Journal of Medicine 2017;376(8):729-41. [DOI: 10.1056/NEJMoa1612348] - DOI - PMC - PubMed
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Asida 2013 {published data only}
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Cao 2013 {published data only}
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Chuah 2015 {published data only}
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Cinotti 2014 {published data only}
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Duncan 2015 {published data only}
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Ellenberger 2018 {published data only}
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Giakoumidakis 2013 {published data only}
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Gupta 2020 {published data only}
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Mikaeili 2012 {published data only}
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Mularski 2012 {published data only}
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NCT00394303 {published data only}
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NCT00487162 {published data only}
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NCT03526536 {published data only}
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Okabayashi 2014 {published data only}
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Pasquel 2020 {published data only}
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Pezzella 2014 {published data only}
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Polderman 2017 {published data only}
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Punke 2014 {published data only}
    1. Punke MA, Goepfert MS, Kluge S, Reichenspurner H, Goetz AE, Reuter DA. Perioperative glycemic control with a computerized algorithm versus conventional glycemic control in cardiac surgical patients undergoing cardiopulmonary bypass with blood cardioplegia. Journal of Cardiothoracic and Cascular Anesthesia 2014;28(5):1273-7. - PubMed
Qu 2012 {published data only}
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Ramírez‐Cáceres 2019 {published data only}
    1. César Ramírez-Cáceres, Estrella Uzcátegui Paz, Ricardo Lozano Hérnandez. Protocol for fast postoperative improvement (FPOI) in gastrointestinal surgery [Protocolo de rapida mejoria posoperatoria ( RAMPO) en cirugía gastrointestinal ]. cirugia y cirujanos 2018;87:151-7. - PubMed
Rujirojindakul 2014 {published data only}
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Santana‐Santos 2019 {published and unpublished data}
    1. Eduesley Santana-Santos, Patricia Hatanaka Kanke, Rita de Cássia Almeida Vieira, Larissa Bertacchini de Oliveira, Renata Eloah de Lucena Ferretti-Rebustin, et al. Impact of intensive glycemic control on acute renal injury: a randomized clinical trial. Acta Paul Enferm 2019;32(6):592-9. [DOI: ]
Schroeder 2012 {published data only}
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Tohya 2018 {published data only}
    1. Tohya A, Kohjitani A, Ohno S, Yamashita K, , Manabe Y, Sugimura M. Effects of glucose-insulin infusion during major oral and maxillofacial surgery on postoperative complications and outcomes. JA Clinical Reports 2018;4(1):9. [DOI: 10.1186/s40981-018-0148-3] - DOI - PMC - PubMed
Wang 2017 {published data only}
    1. Wang Y, Li JP, Song YL, Zhao QH. Intensive insulin therapy for preventing postoperative infection in patients with traumatic brain injury: a randomized controlled trial. Medicine 2017;96(13):e6458. - PMC - PubMed
Welsh 2016 {published data only}
    1. Welsh N, Derby T, Gupta S, Fulkerson C, Oakes DJ, Schmidt K, et al. Inpatient hypoglycemic events in a comparative effectiveness trial for glycemic control in a high-risk population. Endocrine Practice 2016;22(9):1040-7. [DOI: 10.4158/EP151166.OR] - DOI - PubMed
Xue 2018 {published data only}
    1. Xue B, Ruan S, Xie P, Yan K, Gu Z, Meng N, et al. Prospective analysis of glycemic variability in patients with severe traumatic brain injury: modified Leuven's adjustment process versus conventional adjustment process. J Int Med Res 2018;46(4):1505-16. - PMC - PubMed

References to studies awaiting assessment

Hweidi 2021 {published data only}
    1. Hweidi IM, Zytoon AM, Hayajneh AA, Al Obeisat SM, Hweidi AI. The effect of intraoperative glycemic control on surgical site infections among diabetic patients undergoing coronary artery bypass graft (CABG) surgery. Heliyon 2021;7(12):1-10. - PMC - PubMed
Imran‐ul‐hassan  2021 {published data only (unpublished sought but not used)}
    1. Syed Imran-ul-hassan, Sharyar, Muhammad Rashid, Maryam Liaqat, Javairia Saleem, Taiba Zulfiqar1. Outcome of strict peri-operative glycemic control in diabetic patients following open heart surgery. Med. Forum 2021;32(7):43-7.
NCT00899483 {published data only}
    1. NCT00899483. Can enhanced glycaemic control in type II diabetics improve myocardial protection during coronary artery bypass grafting?. https://clinicaltrials.gov/ct2/show/NCT00899483 (first received 12 May 2009). [CLINICALTRIAL.GOV: NCT00899483]
NCT03474666 {published data only}
    1. NCT03474666. Glycemic control and surgical site infection incidence among liver transplantation recipients. https://clinicaltrials.gov/ct2/show/NCT03474666 (first received 22 March 2018). [CLINICALTRIALS.GOV: NCT03474666]
Zadeh 2016 {published data only}
    1. Zadeh FJ, Azemati S. Adjusted tight control blood glucose management in diabetic patients undergoing on pump coronary artery bypass graft. A randomized clinical trial. Journal of Diabetes & Metabolic Disorders 2020;1:1-8. [DOI: ] - PMC - PubMed
    1. Zadeh FJ, Ghazi Nour M. A study on the outcomes of modified tight glucose control for the management of glycemic control in diabetic patients undergoing cardiac surgery. Journal of Pharmacy Research 2016;10(11):764-70.

References to ongoing studies

NCT02032953 {published data only}
    1. NCT02032953. Enhancing the anabolic effect of perioperative nutrition with insulin while maintaining normoglycemia. https://clinicaltrials.gov/ct2/show/NCT02032953 (first received 10 January 2014).
NCT04742023 {published data only}
    1. NCT04742023. Post-operative complications and graft survival with conventional versus continuous glucose monitoring in patients with diabetes mellitus undergoing renal transplantation. https://clinicaltrials.gov/ct2/show/NCT04742023 (first received 5 February 2021).

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References to other published versions of this review

Buchleitner 2012
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