Individualized Blood Glucose Control in ICU. The CONTROLING Study. A Double Blinded Multicentric Randomized Study.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02244073
• Date of registration: 11/09/2014
• Prospective Registration: Yes
• Primary sponsor: Hospices Civils de Lyon
• Public title: Individualized Blood Glucose Control in ICU. The CONTROLING Study. A Double Blinded Multicentric Randomized Study. CONTROLING
• Scientific title: Individualized Blood Glucose Control in ICU.
• Date of first enrolment: May 2015
• Target sample size: 2069
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02244073
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Julien BOHE, MD PhD
• Affiliation: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

Key inclusion & exclusion criteria

Inclusion Criteria:

Patients are eligible for INCLUSION in the study if ALL the following criteria are met:

- Patient is 18 year old or older;

- At time of the patient's admission to the ICU the treating ICU specialist expects the
patient will require treatment in the ICU that extends beyond the calendar day
following the day of admission.

Exclusion Criteria:

- Patients will be EXCLUDED from the study if ONE or MORE of the following criteria are
present:

- Patient or legal surrogate decision maker does not accept the participation to
the study;

- Imminent death (anticipated in less than 48 hours);

- The treating clinicians are not committed to full supportive care (no
resuscitation, no renal replacement therapy limits in dose of vasoactive
support);

- Patient is expected to be eating before the end of the day following admission;

- Admission in ICU for hypoglycemic encephalopathy or patient at risk for
hypoglycaemia ( e.g. known insulin secreting tumour or history of unexplained or
recurrent hypoglycaemia or fulminant hepatic failure);

- If a patient has previously been enrolled in the CONTROLING Study (patients
cannot be enrolled in the CONTROLING Study more than once).



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Critical Illness

Intervention(s)

Drug: Human insulin - Insulin administration to control blood glucose level.

Primary Outcome(s)

All-cause mortality [Time Frame: 90 days after randomization]

Secondary Outcome(s)

incidence and severity of severe hypoglycemia (less than 2.2 mmol/l) [Time Frame: during ICU stay (on average 10 days)]

Length of intensive care unit stay [Time Frame: 90 days]

Need for respiratory support, vasopressor support, dialysis and non-prophylactic antibiotics [Time Frame: during ICU stay (on average 10 days)]

All-cause mortality [Time Frame: 28 days after randomization and at ICU discharge]

Secondary ID(s)

2013.808

2013-A00806-39

Source(s) of Monetary Support

Please refer to primary and secondary sponsors