Septic Shock
Conditions
Keywords
GIK, septic shock, sepsis
Brief summary
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.
Interventions
DRUGGIK
12 hour infusion of GIK solution
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Suspected or confirmed infection; 2. 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 3. Initiation of quantitative resuscitation protocol in the ED; 4. Requirement of high dose vasopressors (defined as a cumulative vasopressor index = 4) to treat shock
Exclusion criteria
1. Age \<18 years; 2. Pregnancy; 3. Any primary diagnosis other than sepsis; 4. Established Do Not Resuscitate status or advanced directives restricting aggressive care or treating physician deems aggressive care unsuitable; 5. Known hyperkalemia (serum potassium \>5.5); 6. Dialysis-dependent renal failure; 7. Anticipated requirement for immediate surgery (within 24 hours); 8. Active participation in another interventional study; 9. Transferred from another hospital setting with sepsis therapy initiated; 10. Inability to obtain informed consent; 11. Cardiopulmonary resuscitation (chest compression or defibrillation) prior to enrollment; 12. Active malignancy currently under treatment (chemo- or radiation therapy); 13. Known systemic allergy to insulin; 14. History of periodic paralysis associated with carbohydrate loading; 15. Receiving continuous intravenous inotropic support (including dobutamine, milrinone, amrinone, and levosimendan).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute safety endpoint (explicit definitions) | During infusion |
| Change in SOFA score, microcirculatory flow | During infusion |
Countries
United States
Outcome results
None listed