Diabetes Mellitus After Intensive Care Admission (DIAFIC)
Stress hyperglycaemia is commonly observed during hospitalization in the intensive care unit (ICU) and has been shown to adversely influence outcome. It has been hypothesized that, when it occurs in previously non-diabetic patients, it reflects a latent disturbance of the glucose metabolism. Assessing the incidence of this phenomenon and identifying its risk factors could support prevention, detection and early treatment of impending diabetes mellitus type 2. We will perform a glucose tolerance test approximately 6-9 months post-ICU admission to screen for disorders of glucose metabolism. Furthermore, we examined characteristics that could have predicted the post-discharge disturbances: patient characteristics, parameters of disease severity and of glucose metabolism, as well as the FINDRISC (Finnish Diabetes Risc Score). We plan to enroll 400 patients.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Incidence and Predisposing Factors for the Development of Glucose Metabolism Disturbances and Diabetes Mellitus After Intensive Care Admission|
- Glucose metabolism disturbance [ Time Frame: 6-9 months after ICU discharge ] [ Designated as safety issue: No ]At a follow-up visit, patients will have their blood glucose levels sampled both after fasting and 2 hours after an oral glucose tolerance test (OGTT). HbA1c levels will be sampled once as well. Possible disturbances in glucose metabolism are the following: isolated impaired fasting glucose (IFG) = fasting plasma glucose (FPG) level of 100-125 mg/dl with the 2-h value after OGTT <140 mg/dl. Isolated impaired glucose tolerance (IGT) = 2-h value after OGTT of 140-199 mg/dl with the fasting level <100 mg/dl. Patients with combined characteristics of IFG and IGT fulfill both criteria (FPG = 100-125 mg/dl and 2-h value after OGTT = 140-199 mg/d). Diabetes mellitus is diagnosed when a patient has one of the following criteria: FPG more or equal to 126mg/dl, 2-h value after OGTT more or equal to 200 mg/dl, HbA1c more or equal to 6.5%.
- Patient characteristics predicting adverse outcome [ Time Frame: 6-9 months after ICU discharge ] [ Designated as safety issue: No ]We will assess the effect of the patient's length, weight, body mass index (BMI), reason for admission, preadmission home medication, treatment during admission (steroids, vasopressors, inotropics, mechanical ventilation, insulin, total parenteral nutrition (TPN), laboratory values including blood glucose and HbA1c on intensive care unit (ICU) admission on our primary outcome parameter. Moreover, we will take into account the Simplified Acute Physiology Score (SAPS-3) and the daily Sequential Organ Failure Assessment (SOFA) score as parameters for disease severity, together with vasopressor or inotropic therapy, mechanical ventilation and length of stay at the hospital and ICU. Furthermore, our patients will complete the Finnish Diabetes Risk Score (FINDRISC) questionnaire during their follow-up visit, and we will compare this result with the primary outcome parameter as well.
|Study Start Date:||February 2012|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02180555
|Contact: Philippe G Jorens, MD, PhD||00323821 ext email@example.com|
|Antwerp University Hospital||Recruiting|
|Edegem, Antwerpen, Belgium, 2650|
|Contact: Philippe G Jorens, MD, PhD 00323821 ext 3635|
|Sub-Investigator: Walter Verbrugghe, MD|
|Sub-Investigator: Tom Schepens, MD PhD|
|Sub-Investigator: Karolien Janssens, MD|
|Principal Investigator: Christophe De Block, MD, PhD|
|Sub-Investigator: Sofie Van Ackerbroeck, MD|
|Sub-Investigator: Philippe G Jorens, MD, PhD|