Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00410852
Status:
COMPLETED
Last Update Posted:
2007-11-02
First Post:
2006-12-12
Brief Title:
Efficacy and Safety of Three Insulin Protocols in Medical Intensive Care Unit Patients
Sponsor:
Hospital Israelita Albert Einstein
Organization:
Hospital Israelita Albert Einstein
Study Overview
Official Title:
Randomized Study to Evaluate the Efficacy and Safety of Two Endovenous Insulin Protocols and a Subcutaneous Insulin Protocol in Critically Ill Patients
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the efficacy and safety of three insulin algorithms in medical ICU patients MICU
Detailed Description:
Strict glycemic control has been recommended for critically ill patients However its implementation may face difficulties with increased nursing workload inadequate glucose control and higher risk of hypoglycemia
We designed a computer guided protocol to adjust endovenous insulin infusion aiming glucose levels between 100mgdl and 130 mgdl This trial evaluates the efficacy and safety of this protocol algorithm A compared to a standard endovenous insulin infusion protocol algorithm B and a conventional subcutaneous insulin protocol algorithm C
Methods MICU patients with at least one blood glucose 150 mgdL and who are on mechanical ventilation or had SIRS or are admitted because of trauma or burn will be randomized to one of the following treatments algorithm A - continuous insulin infusion with adjustments guided by hand held device or desktop software targeting glucose levels between 100mgdL-130mgdL algorithm B - continuous insulin aiming glucose levels between 80mgdl-110mgdl using Van den Berghes insulin protocol algorithm C - conventional treatment - intermittent subcutaneous administration of insulin if blood glucose levels exceeds 150mgdL insulin will be administered as IV boluses in hypotensive patients
The randomization list was generated in blocks of six by computer software Patients will be randomly assigned in a 111 ratio to have their glucose controlled by one of the three insulin algorithms with the use of a central computerized system accessed by Internet permitting concealment of allocation list Randomization will be stratified according to study site
The study is planned to enroll 165 patients in order to have 80 power to detect a 20mgdl difference in blood glucose means between groups assuming standard deviation equal to 33 mgdl and two-tailed alpha equal to 005 Efficacy will be measured by the mean of patients median blood glucose and safety measured by the incidence of hypoglycemia 40 mgdL Analysis will follow the intention-to-treat principle
We designed a computer guided protocol to adjust endovenous insulin infusion aiming glucose levels between 100mgdl and 130 mgdl This trial evaluates the efficacy and safety of this protocol algorithm A compared to a standard endovenous insulin infusion protocol algorithm B and a conventional subcutaneous insulin protocol algorithm C
Methods MICU patients with at least one blood glucose 150 mgdL and who are on mechanical ventilation or had SIRS or are admitted because of trauma or burn will be randomized to one of the following treatments algorithm A - continuous insulin infusion with adjustments guided by hand held device or desktop software targeting glucose levels between 100mgdL-130mgdL algorithm B - continuous insulin aiming glucose levels between 80mgdl-110mgdl using Van den Berghes insulin protocol algorithm C - conventional treatment - intermittent subcutaneous administration of insulin if blood glucose levels exceeds 150mgdL insulin will be administered as IV boluses in hypotensive patients
The randomization list was generated in blocks of six by computer software Patients will be randomly assigned in a 111 ratio to have their glucose controlled by one of the three insulin algorithms with the use of a central computerized system accessed by Internet permitting concealment of allocation list Randomization will be stratified according to study site
The study is planned to enroll 165 patients in order to have 80 power to detect a 20mgdl difference in blood glucose means between groups assuming standard deviation equal to 33 mgdl and two-tailed alpha equal to 005 Efficacy will be measured by the mean of patients median blood glucose and safety measured by the incidence of hypoglycemia 40 mgdL Analysis will follow the intention-to-treat principle
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None