Rapid Administration of Insulin in Sepsis

Study Overview
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Brief Summary
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The purpose of this study is to determine if a glucose-insulin-potassium (GIK) solution can be safely administered to patients with septic shock. GIK has been used in thousands of critically ill patients in research studies with very few safety concerns. However, there is a lack of data in regards to patients with septic shock. There are many reasons to believe that GIK would be beneficial in sepsis, including improving heart function and decreasing inflammation. This study will administer intravenous GIK for 12 hours continuously and monitor 10 subjects for 24 hours. A control arm will be used and 10 patients will receive the same monitoring but will not receive GIK.

Official Title
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Rapid Administration of Insulin in Sepsis: A Pilot Study

Conditions
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Septic Shock

Intervention / Treatment
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* Drug: GIK


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suspected or confirmed infection; Any two of four criteria of systemic inflammatory response: Temperature > 100.4° or < 96.8° F Heart rate > 90 beats/minute Respiratory rate > 20 breaths/min. or PaCO2 < 32 mm Hg WBC >12,000 or < 4000 cells/µL or > 10% bands Initiation of quantitative resuscitation protocol in the ED; Requirement of high dose vasopressors (defined as a cumulative vasopressor index = 4) to treat shock Exclusion Criteria: Age <18 years; Pregnancy; Any primary diagnosis other than sepsis; Established Do Not Resuscitate status or advanced directives restricting aggressive care or treating physician deems aggressive care unsuitable; Known hyperkalemia (serum potassium >5.5); Dialysis-dependent renal failure; Anticipated requirement for immediate surgery (within 24 hours); Active participation in another interventional study; Transferred from another hospital setting with sepsis therapy initiated; Inability to obtain informed consent; Cardiopulmonary resuscitation (chest compression or defibrillation) prior to enrollment; Active malignancy currently under treatment (chemo- or radiation therapy); Known systemic allergy to insulin; History of periodic paralysis associated with carbohydrate loading; Receiving continuous intravenous inotropic support (including dobutamine, milrinone, amrinone, and levosimendan).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Glucose-insulin-potassium | Drug: GIK<br>* 12 hour infusion of GIK solution<br>|
| No Intervention: 2<br>Control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute safety endpoint (explicit definitions) |  | During infusion | 
| Change in SOFA score, microcirculatory flow |  | During infusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GIK, septic shock, sepsis