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Clinical Trial Details

Trial ID: L2324
Source ID: NCT04284722
Associated Drug: Metformin Hydrochloride
Title: Perioperative Continuation of Metformin Therapy in Patients With Typ 2 Diabetes Mellitus Undergoing Non-cardiac Surgery
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Hyperglycemia|Metformin|Type 2 Diabetes|Hyperlactatemia
Interventions: DRUG: Metformin Hydrochloride
Outcome Measures: Primary: Incidence of Perioperative Hyperglycemia, blood glucose \>180mg/dl (10mmol/l) and/or necessity of additive administration of insulin s.c. during the time frame, 24 hours pre-op until 24 hours post-op | Secondary: Perioperative blood glucose control, mean plasma glucose at 4 defined dates: 24h pre-op, intra-op, 2hours post-op and 24h post-op, 24 hours pre-op until 24 hours post-op|Incidence hypoglycemia, blood sugar levels \< 70mg/dl (3.9mmol/l), 24 hours pre-op until 24 hours post-op|Perioperative lactate levels, mediane lactate levels at 4 defined dates: 24h pre-op, intra-op, 2 hours post-op and 24h post-op, 24 hours pre-op until 24 hours post-op|Incidence of hyperlactatemia, blood lactate values \>4mmol/L at least at one of 4 measurement dates: 24h pre-op, intra-op, 2 hours post-op, 24 hours post-op, 24 hours pre-op until 24 hours post-op|Perioperative renal function, median serum-creatinine value at 24h pre-op and 24h post-op, 24 hours pre-op until 24 hours post-op|Hospitalization Duration, median time period from day of surgery until discharge from hospital, up to 4 weeks|Mortality, In-Hospital mortality, up to 4 weeks
Sponsor/Collaborators: Sponsor: Kepler University Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 400
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2020-02
Completion Date: 2021-04
Results First Posted:
Last Update Posted: 2020-02-26
Locations:
URL: https://clinicaltrials.gov/show/NCT04284722